Übersicht zu onkologischen studien am universitätsklinikum leipzig
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Übersicht zu onkologischen Studien am Universitätsklinikum Leipzig Stand: Juni 2021
Liebe Kolleginnen und Kollegen,
der Studienflyer gibt Ihnen Übersicht über die ak-
tiven onkologischen Therapiestudien am Universi-
tätsklinikum Leipzig, in denen wir Patienten die
bestmögliche Versorgung nach aktuellem Stand der
klinischen Forschung anbieten können.
Sie finden die Studien nach Indikationen sortiert.
Aus Gründen der Übersichtlichkeit sind nur inter-
ventionelle Studien aufgelistet. Bitte nehmen Sie
mit der Studienassistenz Kontakt auf, wenn Sie wei-
tere Informationen zu einer Studie erhalten wollen.
Sie dürfen sich auch immer an das Studienteam
des Universitären Krebszentrums wenden. Wir hel-
fen Ihnen gerne weiter.
Wir freuen uns auf eine ausgezeichnete klinisch-
wissenschaftliche Kooperation mit Ihnen und hof-
fen im Sinne der Patienten, dass unser Leipziger
Studienportfolio weiterhin intensiv genutzt wird.
Mit kollegialen Grüßen
Prof. Dr. Florian Lordick Dr. Ivonne Haffner
Direktor des UCCL Leitung
klinische Forschung
Dr. Gertraud Stocker
ärztliche Leitung
StudienteamAdenokarzinom Magen und GEJ
Primärtherapie,
neoadjuvant/perioperativ/
postoperativ
VESTIGE Sophia Schmidt 0341 9712596
Adjuvant immunotherapy in patients with resected gastric
cancer following preoperative chemotherapy with high risk
for recurrence (N+ and/or R1): an open label randomized
controlled phase-2-study (VESTIGE)
EORTC
Sophia Schmidt 0341 9712596
Innovation
Integration of Trastuzumab, with or without Pertuzumab, into
perioperative chemotherapy of HER-2 positive stomach
cancer: the INNOVATION-TRIAL
RACE Sophia Schmidt 0341 9712596
Neoadjuvant Radiochemotherapy versus Chemotherapy
for Patients with Locally Advanced, Potentially Resectable
Adenocarcinoma of the Gastroesophageal Junction (GEJ)
CARDIA-Trial Nicole Kreuser 0341 9712590
Surgery for adenocarcinoma of the gastroesophageal
junction (GEJ) type II: Transthoracic esophagectomy vs.
transhiatal extended gastrectomy
ProPec Nicole Kreuser 0341 9712590
Phase II Pilotstudie zur Verminderung der Peritonealkarzinose-
Inzidenz nach kurativer Gastrektomie eines Magenkarzinoms
oder Adenokarzinoms des gastroösophagealen Übergangs
durch hypertherme intraperitoneale Chemoperfusion
PREVENT Nicole Kreuser 0341 9712590
Preventive HIPEC in combination with perioperative FLOT
versus FLOT alone for resectable diffuse type gastric and
gastroesophageal junction Type II/III adenocarcinoma
11. Linie palliativ
lokal fortgeschritten oder metastasiert
Spotlight Sophia Schmidt 0341 9712596
A phase 3, global, multi-center, double-blind, randomized,
efficacy study of Zolbetuximab (IMAB362) plus mFOLFOX6
compared with placebo plus mFOLFOX6 as first-line treatment
of subjects with Claudin (CLDN)18.2-positive, HER2-
negative, locally advanced unresectable or metastatic gastric
or gastroesophageal junction (GEJ) adenocarcinoma
Destiny 03 Sophia Schmidt 0341 9712596
Phase 1/2b multicenter, open-label, dose-escalation and
dose-expansion study to evaluate the safety, tolerability,
pharmacokinetics, immunogenicity, and antitumor activity
of Trastuzumab Deruxtecan (DS-8201a) monotherapy and
combinations in adult subjects with HER2 overexpressing
gastric cancer
Mahogany Sophia Schmidt 0341 9712596
Phase 2/3 multicenter, international study in patients with
metastatic or locally advanced, treatment-naïve, HER2-
positive gastric or gastroesophageal junction cancer
2. Linie palliativ,
lokal fortgeschritten/metastasiert
CA018-003
Sophia Schmidt 0341 9712596
FRACTION
A Phase 2, fast real-time assessment of combination therapies
in immuno-oncology study in participants with advanced
gastric cancer (FRACTION-gastric cancer)
Ramiris Sophia Schmidt 0341 9712596
Ramucirumab plus Irinotecan / Leucovorin / 5-FU versus
Ramucirumab plus Paclitaxel in patients with adavanced
or metastatic adenocarcinoma of the stomach or
gastroesophageal junction, who failed one prior line of
palliative chemotherapy
20180290-
Sophia Schmidt 0341 9712596
AMG199
A global phase 1 study evaluating the safety, tolerability,
pharmacokinetics, and efficacy of the half-life extended
bispecific T-cell engager AMG 199 in subjects with MUC17-
positive gastric and gastroesophageal junction cancer
220180292-
Sophia Schmidt 0341 9712596
AMG910
A global phase 1 study evaluating the safety, tolerability,
pharmacokinetics, and efficacy of the half-life extended
bispecific T-cell engager AMG 910 in subjects with Claudin
18.2-positive gastric and gastroesophageal junction
adenocarcinoma
Plattenephitelkarzinom Ösophagus
Primärtherapie
Scyscraper Sophia Schmidt 0341 9712596
A phase III, randomized, double-blind, placebo-controlled
study of Atezolizumab with or without Tiragolumab (anti-TIGIT
antibody), in patients with unresectable locally advanced
esophageal squamous cell carcinoma
Hepatozelluläres Karzinom (HCC)
Primärtherapie
IRITACE Carolin Straube 0341 9712328
Transarterielle Chemoembolization (TACE) mit Irinotecan und
Mitomycin C im Vergleich zur TACE mit Doxorubicin bei
Patienten mit nicht kurativ behandelbarem hepatozellulärem
Karzinom - IRITACE - eine randomisierte multicenter Phase 2
Studie. Eine Studie der „German Alliance for Liver Cancer“
(GALC)
1. Linie palliativ,
lokal fortgeschritten/metastasiert
CA209-9DW Madlen Steger 0341 9712474
A randomized, multi-center, Phase 3 study of Nivolumab in
combination with Ipilimumab compared to Sorafenib or
Lenvatinib as first-line treatment in participants with advanced
hepatocellular Carcinoma
2. Linie palliativ,
lokal fortgeschritten/metastasiert
I4T-MC-JVDE
Katja Hirschmann 0341 9712474
(REACH 2)
Randomized, double-blind, placebo-controlled, phase 3
study of Ramucirumab and Best Supportive Care (BSC) versus
placebo and BSC as second-line treatment in patients with
hepatocellular carcinoma and elevated baseline Alpha-
Fetoprotein (AFP) following first-line therapy without first
Sorafenib
3CaboRISE Carolin Straube 0341 9712474
A phase II study evaluating reduced starting dose and
dose escalation of Cabozantinib as second-line therapy for
advanced HCC in patients with compensated liver cirrhosis
Kolorektales karzinom
Primärtherapie
Radianc Sandra Schuster 0341 9716681
Radiochemotherapy +/- Durvalumab for locally-advanced
anal carcinoma. A multicenter, randomized, phase II trial of
the German Anal Cancer Study Group
ACO/ARO/
Sandra Schuster 0341 9716681
AIO-18.1
Preoperative oxaliplatin-based chemoradiotherapy and
consolidation chemotherapy versus fluorouracil-based
chemoradiotherapy for MRI-defined intermediate and high-
risk rectal cancer patients. A randomized phase III trial of the
German Rectal Cancer Study Group
ACO/ARO/
Sophia Schmidt 0341 9712596
AIO-18.2
Preoperative FOLFOX versus postoperative risk-adapted
chemotherapy in patients with locally advanced rectal cancer
and low risk for local failure: A randomized phase III trial of
the German Rectal Cancer Study Group
CIRCULATE Nicole Kreuser 0341 9712590
Evaluierung der adjuvanten Therapie beim Dickdarmkrebs im
Stadium II nach ctDNA-Bestimmung
Primärtherapie Lebermetastasen
PARLIM Yvonne Kurth 0341 9712226
Panitumumab after resection of liver metastases from
colorectal cancer in RAS wild-type patients
41. Linie palliativ,
lokal fortgeschritten/metastasiert
FIRE-4 Sophia Schmidt 0341 9712596
Randomised study of the efficacy of Cetuximab rechallenge
in patients with metastatic colorectal cancer (RAS wild-type)
responding to first-line treatment with FOLFIRI plus Cetuximab
MoLiMor Sophia Schmidt 0341 9712596
Modulation of the FOLFIRI-based standard 1st-line therapy
with cetuximab, controlled by monitoring the RAS mutation
load by liquid biopsy in RAS-mutated mCRC patients
2. Linie palliativ,
lokal fortgeschritten/metastasiert
RAMTAS Yvonne Kurth 0341 9712226
A Phase IIb study with run in safety phase of Ramucirumab
in combination with TAS102 vs. TAS102 monotherapy
refractory metastatic colorectal cancer patients
3. Linie palliativ,
lokal fortgeschritten/metastasiert
FIRE-4 Sophia Schmidt 0341 9712596
Randomised study of the efficacy of Cetuximab rechallenge
in patients with metastatic colorectal cancer (RAS wild-type)
responding to first-line treatment with FOLFIRI plus Cetuximab
Cholangiokarzinom
1. Linie palliativ,
lokal fortgeschritten/metastasiert
FIGHT II Yvonne Kurth 0341 9712226
A Phase 3, open-Label, randomized, active-controlled,
multicenter study to evaluate the efficacy and safety of
Pemigatinib versus Gemcitabine plus Cisplatin chemotherapy
in first-line treatment of participants with unresectable or
metastatic cholangiocarcinoma with FGFR2 rearrangement
(FIGHT-302)
PCIA203/18 Yvonne Kurth 0341 9712226
A multi-centre, randomised, open-label, phase 2 study
to assess the safety, tolerability and efficacy of Fimaporfin-
induced photochemical internalisation of Gemcitabine
complemented by Gemcitabine/Cisplatin chemotherapy
versus Gemcitabine/Cisplatin alone in patients with
inoperable cholangiocarcinoma
5Lungenkarzinom
Supportivtherapie
ANAM-17-21 Patricia Berger 0341 9712674
A phase III randomized, double-blind, placebo-controlled,
multicenter study to evaluate the efficacy and safety
of ANAMORELIN HCL for the treatment of malignancy
associated weight loss and anorexia in adult patients with
advanced NSCLC
1. Linie palliativ,
lokal fortgeschritten/metastasiert
MK-3475-671-
Patricia Berger 0341 9712674
06
A Phase III, randomized, double-blind trial of Platinum
doublet Chemotherapy +/- Pembrolizumab as neoadjuvant/
adjuvant therapy for participants with resectable stage II, IIIa,
and resecetable IIIb NSCLC (Keynote-671)
ABP Patricia Berger 0341 9712674
APB – Advancing Brigatinib Properties in anaplastic
lymphoma kinase positive non-small cell lung cancer
(ALK+NSCLC) patients by deep phenotyping
Prostatakarzinom
Primärtherapie
LAP-01 Dr. Holze 0341 9717629
Prospektive Studie zum Vergleich der Roboter-assistierten
und der konventionellen laparoskopischen/endoskopischen
radikalen Prostatektomie
ProLy Dr. Holze 0341 9717629
Prospektive Erfassung der Lymphozelenhäufigkeit bei
robotisch–assistierten-minimal-invasiven radikalen
Prostatektomien unter Bildung eines peritonealen Schwenk-
lappens: eine randomisierte kontrollierte verblindete klinische
Multicenter-Studie
6Zervixkarzinom
Primärtherapie
Juliane Gehrt 0341 9711379
Neue Tumoroperationen auf der Grundlage der
ontogenetischen Anatomie für die Behandlung des Zervix-
und Vaginalkarzinoms: TMMR, KMMR, EMMR, LEER und
tLNE
Vulvakarzinom
Primärtherapie
Juliane Gehrt 0341 9711379
Vulvafeldresektion und anatomische Rekonstruktion:
Neues operatives Konzept für die Lokalbehandlung des
Vulvakarzinoms
Ovarialkarzinom
Primärtherapie
AGO23/
Juliane Gehrt 0341 9711379
DUO-O
A phase III randomised, double-blind, placebo-controlled,
multicentre study of Durvalumab in combination with
chemotherapy and Bevacizumab, followed by maintenance
Durvalumab, Bevacizumab and Olaparib in newly
diagnosed advanced ovarian cancer patients
2. Linie palliativ,
lokal fortgeschritten/metastasiert
COMPASS Juliane Gehrt 0341 9711379
Comparison of quality of life between Trabectedin/PLD and
standard Platinum-based therapy in patients with Platinum
sensitive recurrent ovarian, fallopian tube and peritoneal
cancer
Endometriumkarzinom
Primärtherapie
Juliane Gehrt 0341 9711379
Prospektive monozentrische Beobachtungsstudie: Peritoneale
mesometriale Resektion (PMMR), totale mesometriale
Resektion (TMMR+) und therapeutische Lymphonodektomie
(tLNE) – neue Tumoroperation auf der Grundlage der
ontogenetischen Anatomie zur Behandlung des frühen
Endometriumkarzinoms (FIGO-Stadium I und II)
71+2. Linie palliativ,
lokal fortgeschritten/metastasiert
SIENDO/KCP-
Juliane Gehrt 0341 9711379
330-024
A randomized, double-blind, phase 3 trial of maintenance
with Selinexor / Placebo after combination chemotherapy for
patients with advanced or recurrent endometrial cancer
Mammakarzinom
Primärtherapie
ADAPTcycle Juliane Gehrt 0341 9711379
Adjuvante, auf dynamische Marker adjustierte,
personalisierte Therapie zum Vergleich einer endokrinen
Behandlung plus Ribociclib mit Chemotherapie bei
Hormonrezeptor-positivem, HER2-Rezeptor negative, mittleres
Risiko aufweisendem frühen Brustkrebs
Checkmate
Juliane Gehrt 0341 9711379
7FL
Randomisierte, multizentrische, doppelblinde, Placebo-
kontrollierte Phase 3-Studie zu Nivolumab vs. Placebo
in Kombination mit neoadjuvanter Chemotherapie und
adjuvanter endokriner Therapie bei Patienten mit primärem
Estrogenrezeptor-positivem, humaner-epidermaler-
Wachstumsfaktor-Rezeptor-2-negativem Hochrisiko-Brustkrebs
(ER+/HER2-)
1. Linie palliativ,
lokal fortgeschritten/metastasiert
EPIKB3-
Sophia Schmidt 0341 9712596
CBYL719H12301
A phase III, multicenter, randomized, double-blind, placebo-
controlled study of alpelisib (BYL719) in combination with
nab-paclitaxel in patients with advanced triple negative
breast cancer with either phosphoinositide-3-kinase catalytic
subunit alpha (PIK3CA) mutation or phosphatase and tensin
homolog protein (PTEN) loss without PIK3CA mutation
8Contessa
Juliane Gehrt 0341 9711379
TRIO
Eine multizentrische Studie der Phase II zu Tesetaxel plus drei
verschiedenen PD-(L)1-Inhibitoren bei Patienten mit dreifach
negativem, lokal fortgeschrittenem oder metastasierendem
Brustkrebs und einer Monotherapie mit Tesetaxel bei älteren
Patienten mit HER2-negativem, lokal fortgeschrittenem oder
metastasierendem Brustkrebs
ZNS-Tumore
Primärtherapie
EORTC-1709-
Nadja Talhi 0341 9718210
BTG
A phase III trial of Marizomib in combination with standard
Temozolomide-based radiochemotherapy versus standard
Temozolomide-based radiochemotherapy alone in patients
with newly diagnosed glioblastoma
DOSIS Nadja Talhi 0341 9718210
Dose-intensified image-guided fractionated stereotactic body
radiation therapy for painful spinal metastases (DOSIS)
versus conventional radiation therapy: a phase II randomised
controlled trial
SNOXA Nadja Talhi 0341 9718210
Single-arm, Dose-Escalation, Phase 1/2 Study of Olaptesed
Pegol (NOX-A12) in Combination with Irradiation in
Inoperable or Partially Resected First-line Glioblastoma
Patients with Unmethylated MGMT Promoter
EORTC IADL Nadja Talhi 0341 9718210
Development of a questionnaire to measure instrumental
activities of daily living (I-ADL) in patients with primary brain
tumors and brain metastases: Phase IV international field
testing
2. Linie palliativ,
lokal fortgeschritten/metastasiert
RAGNAR
(Solide high
Sandra Schuster 0341 9720546
grade ZNS-
Tumors)
A Phase 2 Study of Erdafitinib in subjects with advanced
solid tumors and FGFR gene alteration
9Kopf-Hals-Karzinom Primärtherapie EORTC 1420 Nadja Talhi 0341 9718210 Phase III study assessing the “best of” radiotherapy compared to the “best of” surgery (trans-oral surgery (TOS)) in patients with T1-T2, N0-N1 oropharyngeal, supraglottic carcinoma and with T1, N0 hypopharyngeal carcinoma ADRISK Kathrin Vogel 0341 9725052 Postoperative adjuvant radiochemotherapy (aRCH) with Cisplatin (C) versus aRCH with C and Pembrolizumab (P) in locally advanced head and neck squamous cell carcinoma (HNSCC); multicenter randomized Phase II study within the German interdisciplinary study group of German Cancer Society (IAG KHT); Pembro-Adjuvant-highRisk NadiHN Kathrin Vogel 0341 9725052 An Open Label, Randomized Phase 2 Clinical Trial of Nivolumab investigating efficacy and safety of Nivolumab given once prior to, concurrent to the radiotherapy (RT) and as maintenance therapy over 12 months in patients with advanced resectable HNSCC after surgery 1. Linie palliativ, lokal fortgeschritten/metastasiert EORTC 1206 Kathrin Vogel 0341 9725052 Eine randomisierte Phase II Studie zur Untersuchung der Wirksamkeit und Sicherheit einer Chemotherapie gegenüber einer Androgendeprivationstherapie bei Patienten mit einem Wiederauftreten und/oder Metastasen eines Speicheldrüsenkrebses, welcher Androgen-Rezeptoren aufweist KO-TIP-007 Kathrin Vogel 0341 9725052 A pivotal study of Tipifarnib in patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) with HRAS mutations who have failed at least one prior line of therapy ISA101b Kathrin Vogel 0341 9725052 Eine randomisierte, doppelblinde, placebokontrollierte Phase- 2-Studie zu Cemiplimab im Vergleich zur Kombination aus Cemiplimab und ISA101b bei der Behandlung von Patienten mit HPV16-positivem Oropharynxkarzinom (OPK) 10
2. Linie palliativ,
lokal fortgeschritten/metastasiert
ISA101b Kathrin Vogel 0341 9725052
Eine randomisierte, doppelblinde, placebokontrollierte Phase-
2-Studie zu Cemiplimab im Vergleich zur Kombination aus
Cemiplimab und ISA101b bei der Behandlung von Patienten
mit HPV16-positivem Oropharynxkarzinom (OPK)
AbbVie M19-
Kathrin Vogel 0341 9725052
894
A Phase 1b, Multicenter, Open-Label Study to Determine
the Safety, Tolerability, Pharmacokinetics, and Preliminary
Efficacy of ABBV-368 plus Tilsotolimod and Other Therapy
Combinations in Subjects with Recurrent/Metastatic Head
and Neck Squamous Cell Carcinoma
INTERLINK-1 Kathrin Vogel 0341 9725052
Phase 3 Randomized, Double-blind, Multicenter, Global
Study of Monalizumab or Placebo in Combination With
Cetuximab in Patients With Recurrent or Metastatic
Squamous Cell Carcinoma of the Head and Neck Previously
Treated With an Immune Checkpoint Inhibitor
Melanom
neoadjuvante Therapie
Silke
Pivotal PH- 0341 9718750/
Weidauer-Zuniga/
19IL2TNF-02/15 0341 9720015
Anja Zeuner
A phase III, open-label, randomized, controlled multi-
center study of the efficacy of L19IL2/L19TNF neoadjuvant
intratumoral treatment followed by surgery versus surgery
alone in clinical stage III B/C melanoma patients
adjuvante Therapie
Mandy Dathe/
0341 9718380/
NIVO MELA Silke Weidauer-
0341 9718750
Zuniga
A phase III randomized, controlled trial with adjuvant
nivolumab treatment and biomarker-based risk stratification in
in stage II high risk melanoma
11lokal fortgeschritten oder metastasiert
Mandy Dathe/
0341 9718380/
MK-7902-003 Silke Weidauer-
0341 9718750
Zuniga
A phase 3 randomized, placebo-controlled trial to evaluate
the safety and efficacy of Pembrolizumab (MK-3475)
and Lenvatinib (E7080/MK-7902) versus Pembrolizumab
alone as first-line intervention in participants with advanced
melanoma
Silke
0341 9718750/
CA045-001 Weidauer-Zuniga/
0341 9720015
Anja Zeuner
A phase 3, randomized, open-label study of NKTR-214
combined with Nivolumab versus Nivolumab as first-line
intervention in participants with advanced melanoma
Mandy Dathe/
0341 9718380/
V937-011 Silke Weidauer-
0341 9718750
Zuniga
A Phase 2, Randomized Clinical Study of Intravenous or
Intratumoral Administration of V937 in Combination with
Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in
Participants with Advanced/Metastatic Melanoma
Merkelzell-Karzinom
lokal fortgeschritten oder metastasiert
Anja Zeuner/
0341 9720015/
Merklin2 Silke Weidauer-
0341 9718750
Zuniga
A phase II, open label study to investigate the efficacy and
safety of Domatinostat in combination with Avelumab in
patients with advanced unresectable/metastatic merkel cell
carcinoma progressing on anti-PD-(L)1 antibody therapy
12Plattenepithelzellkarzinom der Haut
lokal fortgeschritten oder metastasiert
Silke Weidauer-
0341 9718750/
AliCe Zuniga/
0341 9718380
Mandy Dathe
Einarmige, offene, multizentrische Phase II Studie zur
Untersuchung der klinischen Aktivität und Sicherheit
von Avelumab in Kombination mit Cetuximab bei
Studienteilnehmern mit nicht reserzierbarem Stadium III oder
IV Plattenepithelkarzinom der Haut
Anja Zeuner/
0341 9720015/
Cerpass Silke Weidauer-
0341 9718750
Zuniga
A randomized, controlled, open-label, phase 2 study of
Cemiplimab as a single agent and in combination with
RP1 in patients with advanced cutaneous squamous cell
carcinoma
Sarkom
rEECur Sophia Schmidt 0341 9712596
International randomised controlled trial for the treatment of
recurrent and primary refractory ewing sarcoma
Solide Tumore
ab 1. Linie palliativ,
lokal fortgeschritten/metastasiert
Nadja Talhi/ 0341 9718210/
RAGNAR
Sophia Schmidt 03419712596
A phase 2 study of Erdafitinib in subjects with advanced
solid tumors and FGFR gene alterations
Myeloische Erkrankungen
AML
Primärtherapie
AG-120 / CC-
Sascha Grabow 0341 9712621
90012 / AGILE
Phase 3a Studie mit AG 120 bei Patienten mit akuter
myeloischer Leukämie (AML) mit einer IDH1 Mutation
13PALOMA Sascha Grabow 0341 9712621 Primary comparison of liposomal Anthracycline based treatment versus conventional care strategies before allogenic stem cell transplantation in patients with higher risk MDS and oligoblastic AML – the PALOMA study ASTX727-02 Nicole Thorn 0341 9712658 A phase 3, randomized, open-label, crossover study of ASTX727 (Cedazuridine and Decitabine fixed-dose combination) versus IV Decitabine in subjects with myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), and acute myeloid leukemia (AML) DaunoDouble Sascha Grabow 0341 9712621 Randomized comparison between two dose levels of Daunorubicin and between one versus two cycles of induction therapy for adult patients with acute myeloid leukemia ≤ 65 years Primärtherapie – Early Clinical Trials Unit Leipzig 74494550 AML1003 Karolin Hubert 0341 9720363 ELEVATE An open-label, multicenter, phase 1b study of JNJ- 74494550 (Cusatuzumab; Anti-CD70 monoclonal antibody) in combination with background therapy for the treatment of subjects with acute myeloid leukemia IMGN632-0802 Karolin Hubert 0341 9720363 Phase 1b/2 study of IMGN632 monotherapy and in combination with Venetoclax and/or Azacytidine in CD123- Positive AML patients (relapsed and front-line) Sekundärtherapie M19-708 Sascha Grabow 0341 9712621 Randomized, open-label, phase III study of Venetoclax and Azacitidine versus standard of care as maintenance therapy for patients with acute myeloid leukemia in first remission after conventional chemotherapy 14
Rezidiv, refraktär
AML003 /
Nicole Thorn 0341 9712658
ARMADA 2000
Phase III multicenter open-label randomized trial to
evaluate efficacy and safety of CPI-613 in combination with
high dose Cytarabine and Mitoxantrone (CHAM) compared
to high dose Cytarabine and Mitoxantrone (HAM) in older
patients (≥60 years) with relapsed/refractory acute myeloid
leukemia (AML)
Mautitius Nicole Thorn 0341 9712658
Midostaurin in MRD positive acute myeloid leukemia after
allogeneic stem cell transplantation
Q-HAM Nicole Thorn 0341 9712658
Quizartinib and high-dose Ara-C plus Mitoxantrone in
relapsed/refractory AML with FLT3-ITD
SHAPE Sascha Grabow 0341 9712621
Treatment of MDS/AML patients with an impending
hematological relapse with Azacitidine alone or in
combination with Pevonedistat - a randomized phase 2 trial
TUD-
Sascha Grabow 0341 9712621
PEMAZA-068
MRD-guided treatment with Pembrolizumab and Azacitidine
in NPM1mut AML patients with an imminent hematological
relapse
ETAL3-ASAP Katrin Stolle 0341 9713134
Evaluation of the impact of remission induction chemotherapy
prior to allogeneic stem cell transplantation in relapsed and
poor-response patients with AML
Rezidiv, refraktär –
Early Clinical Trials Unit Leipzig
CA-4948-102 Karolin Hubert 0341 9720363
A phase 1, open label dose escalation trial evaluating the
safety, pharmacokinetics, pharmacodynamics, and clinical
activity of orally administered CA-4948 in patients with
acute myelogenous leukemia or myelodysplastic syndrome
1567571244
Karolin Hubert 0341 9720363
AML1001
A phase 1, first-in-human, dose escalation study of JNJ-
67571244 (bispecific antibody targeting CD33 and CD3)
in subjects with relapsed or refractory AML or MDS
CD-TCR-001 Karolin Hubert 0341 9720363
A phase I/II, open-label, non-randomized, multicentre,
dose-escalation clinical trial with control group to evaluate
the safety, feasibility and preliminary efficacy of PRAME
TCR modified T cells, MDG1011, in subjects with high risk
myeloid and lymphoid neoplasms
DART - Studie Karolin Hubert 0341 9720363
A phase 1/2, first-in-human, dose escalation study of
MGD006, a CD123 x CD3 dual affinity re-targeting
(DART) bi-specific antibody-based molecule, in patients
with relapsed or refractory acute myeloid leukemia or
intermediate-2/high risk myelodysplastic syndrome
ADVANCE II
Karolin Hubert 0341 9720363
DCOne-002
An international, multicenter, open-label study to evaluate the
efficacy and safety of two different vaccination regiments of
immunotherapy with allogenic dendritic cells, DCP-001, in
patients with acute myeloid leukaemia that are in remission
with persistent MRD
IMGN632-0802 Karolin Hubert 0341 9720363
Phase 1b/2 study of IMGN632 monotherapy and in
combination with Venetoclax and/or Azacytidine in CD123-
positive AML patients (relapsed and front-line)
APL
Primärtherapie
Dr. rer. nat.
APOLLO 0341 9713061
Andrea Bendig
Eine randomisierte Phase-III-Studie zum Vergleich von
Arsentrioxid (ATO) in Verbindung mit ATRA und Idarubicin
versus ATRA in Kombination mit einer Anthracyclin-basierten
Chemotherapie (AIDA) bei Patienten mit neu diagnostizierter,
akuter Promyelozytenleukämie mit Hochrisikomerkmalen
16MDS
Primärtherapie
FGCL-4592-082 Karolin Hubert 0341 9720363
A phase 3 randomized double-blind placebo-controlled
study investigating the efficacy and safety of Roxadustat (FG-
4592) for treatment of anemia in patients with lower risk
myelodysplastic syndrome (MDS) with low red blood cell
(RBC) transfusion burden (LTB)
COMMANDS Karolin Hubert 0341 9720363
A phase 3, open-label, randomized study to compare the
efficacy and safety of Luspatercept (ace-536) versus Epoetin
alfa for the treatment of anemia due to ipss-r very low, low
or intermediate risk myelodysplastic syndromes (MDS) in ESA
naïve subjects who require red blood cell transfusions
ACE-536-
Katja Hammann 0341 9713131
LTFU-001
A phase 3B, open-label, single-arm, rollover study to
evaluate long-term safety in subjects who are participated in
other Luspatercept (ACE-536) clinical trails
M15-954
Sascha Grabow 0341 9712621
VERONA
A randomized, double-blind, phase 3 study evaluating
the safety and efficacy of Venetoclax in combination with
Azacitidine in patients newly diagnosed with higher-risk
myelodysplastic syndrome (higher-risk MDS)
Primärtherapie –
Early Clinical Trials Unit Leipzig
SLN124-002 Karolin Hubert 0341 9720363
A randomised, single-blind, placebo-controlled, phase 1,
single-ascending and multiple-dose study in adult subjects
with alpha/beta-thalassaemia and very low- and low-
risk myelodysplastic syndrome to investigate the safety,
tolerability, pharmacokinetic, and pharmacodynamic
response of SLN124
Rezidiv, refraktär
IDEAL Sascha Grabow 0341 9712621
A single-arm phase II multicenter study of IDH2 (AG 221)
inhibitor in patients with IDH2 mutated myelodysplastic
syndrome – IDEAL
1763935937
Katja Hammann 0341 9713131
MDS3001
A study to evaluate Imetelstat in transfusion-dependent
subjects with IPSS low or intermediate-1 risk
myelodysplastic syndrome (MDS) that is relapsed/refractory
to Erythropoiesis-Stimulating Agent (ESA) treatment
IDH2 Post Allo Katrin Stolle 0341 9713134
Prospective, open-label, non-randomized with 2 single
noncomparative arms, multicenter phase-II trial– Enasidenib
as consolidation or salvage therapy for patients with IDH2
Mutation with Relapse of AML, MDS, and CMML after
allogeneic SCT
SHAPE Sascha Grabow 0341 9712621
Treatment of MDS/AML patients with an impending
Hematological relapse with Azacitidine alone or in
combination with Pevonedistat - a randomized phase 2 trial
PALOMA Sascha Grabow 0341 9712621
Primary comparison of liposomal Anthracycline based
treatment versus conventional care strategies before allogenic
stem cell transplantation in patients with higher risk MDS and
oligoblastic AML – the PALOMA study
BoHemE Sascha Grabow 0341 9712621
A prospective longitudinal cohort study to investigate the
interactions of bone and hematopoiesis in the elderly
Rezidiv, refraktär –
Early Clinical Trials Unit Leipzig
CA-4948-102 Karolin Hubert 0341 9720363
A phase 1, open label dose escalation trial evaluating the
safety, pharmacokinetics, pharmacodynamics, and clinical
activity of orally administered CA-4948 in patients with
acute myelogenous leukemia or myelodysplastic syndrome
DART - Studie Karolin Hubert 0341 9720363
A phase 1/2, first-in-human, dose escalation study of
MGD006, a CD123 x CD3 dual affinity re-targeting
(DART) bi-specific antibody-based molecule, in patients
with relapsed or refractory acute myeloid leukemia or
intermediate-2/high risk myelodysplastic syndrome
1867571244
Karolin Hubert 0341 9720363
AML1001
A phase 1, first-in-human, dose escalation study of JNJ-
67571244 (bispecific antibody targeting CD33 and CD3)
in subjects with relapsed or refractory AML or MDS
64619178
Karolin Hubert 0341 9720363
EDI1001
A phase 1, first-in-human, open-label study of the safety,
pharmacokinetics, and pharmacodynamics of JNJ-
64619178, an inhibitor of protein arginine methyltransferase
5 (PRMT5) in subjects with advanced cancers
CD-TCR-001 Karolin Hubert 0341 9720363
A phase I/II, open-label, non-randomized, multicentre,
dose-escalation clinical trial with control group to evaluate
the safety, feasibility and preliminary efficacy of PRAME
TCR modified T cells, MDG1011, in subjects with high risk
myeloid and lymphoid neoplasms
SLN124-002 Karolin Hubert 0341 9720363
A randomised, single-blind, placebo-controlled, phase 1,
single-ascending and multiple-dose study in adult subjects
with alpha/beta-thalassaemia and very low- and low-
risk myelodysplastic syndrome to investigate the safety,
tolerability, pharmacokinetic, and pharmacodynamic
response of SLN124
MPN
Sekundärtherapie
Dr. rer. nat.
SRA-MMB-301 0341 9713061
Andrea Bendig
A randomized, open-label, phase 3 study to evaluate
the activity of Momelotinib (MMB) or Best Available
Therapy (BAT) in transfusion dependent subjects with
primary myelofibrosis (PMF), post-polycythemia vera (PV)
myelofibrosis, or post-essential thrombocythemia (ET)
myelofibrosis who were previously treated wth JAK inhibitor
therapy
19Sekundärtherapie –
Early Clinical Trials Unit Leipzig
MANIFEST Karolin Hubert 0341 9720363
A phase 1/2 study of CPI-0610, a small molecule inhibitor
of BET Proteins: phase 1 (dose escalation of CPI-0610 in
patients with hematological malignancies) and phase 2
(dose expansion of CPI0610 with and without Ruxolitinib in
patients with myelofibrosis)
CML
Primärtherapie
Dr. rer. nat.
FASCINATION 0341 9713061
Andrea Bendig
Frontline Asciminib combination in chronic phase CML
Rezidiv, refraktär
ENDURE / Dr. rer. nat.
0341 9713061
CML-IX Andrea Bendig
Efficacy and safety of pegylated proline Interferon alpha
2b (AOP2014) in maintaining deep molecular remissions
in patients with chronic myeloid leukemia (CML) who
discontinue ABL-kinase inhibitor therapy - a randomized
phase II, multicenter trial with post-study follow-up
Dr. rer. nat.
DasaHIT trial 0341 9713061
Andrea Bendig
DasaHIT trial, (Dasatinib Holiday for Improved Tolerability)
Treatment optimization for patients with chronic myeloid
leukemia (CML) with treatment naive disease (1st line) and
patients with resistance or intolerance against alternative Abl-
Kinase Inhibitors (≥2nd line)
Dr. rer. nat.
PONDEROSA 0341 9713061
Andrea Bendig
Observational study on CML patients in any phase treated
with Ponatinib (IclusigR) at any dose
20Multiples Myelom
Primärtherapie
AGMT_MM-2 Jenny Dietrich 0341 9720364
A randomized Phase II, 2-armed study in transplant
ineligible (TI) patients with newly diagnosed multiple
myeloma (NDMM) comparing Carfilzomib + Thalidomide
+ dexamethasone (KTd) versus Carfilzomib + Lenalidomide
+ dexamethasone (KRd) induction therapy with respect
to response rates and investigating a Carfilzomib (K)
monotherapy maintenance strategy
AGMT_MM-3 Jenny Dietrich 0341 9720364
DEFENCE
A randomized Phase II, 2-armed study in transplant
ineligible (TI) patients with newly diagnosed multiple
myeloma (NDMM) comparing Carfilzomib + Thalidomide
+ dexamethasone (KTd) versus Carfilzomib + Lenalidomide
+ dexamethasone (KRd) induction therapy with respect
to response rates and investigating a Carfilzomib (K)
monotherapy maintenance strategy
DSMM_XVII Jenny Dietrich 0341 9720364
Elotuzumab (E) in combination with Carfilzomib,
Lenalidomide and Dexamethasone (E-KRd ) versus KRd prior
to and following autologous stem cell transplant in newly
diagnosed multiple myeloma and subsequent maintenance
with Elotuzumab and Lenalidomide versus single-agent
Lenalidomide
Rezidiv, refraktär
68284528
MMY3002 Jenny Dietrich 0341 9720364
Cartitude4
A phase 3 randomized study comparing JNJ-68284528, a
Chimeric Antigen Receptor T cell (CAR-T) therapy directed
against BCMA vs Carfilzomib and Dexamethasone (Kd) or
Daratumumab, Pomalidomide and Dexamethasone (DPd)
in Participants with relapsed and Lenalidomide-refractory
multiple myeloma
DREAMM 8 Jenny Dietrich 0341 9720364
A phase III, multicenter, open-Label, randomized study to
evaluate the efficacy and safety of Belantamab Mafodotin in
combination with Pomalidomide and Dexamethasone (B-Pd)
versus Pomalidomide plus Bortezomib and Dexamethasone
(PVd) in participants with relapsed/refractory multiple
myelom
21Rezidiv, refraktär –
Early Clinical Trials Unit Leipzig
R5458-
Karolin Hubert 0341 9720363
ONC-1826
A phase I/II study that will evaluate the safety and efficacy
of an exciting new BiTE compound REGN5458 (anti-BCMA
x anti-CD3) as treatment in adult patients with relapsed or
refractory multiple myeloma
64007957
Karolin Hubert 0341 9720363
MMY1001
A phase 1/2, first-in-human, open-label, dose escalation
study of Teclistamab, a humanized BCMA x CD3 bispecific
antibody, in subjects with relapsed or refractory multiple
myeloma
Lymphatische Erkrankungen
Primärtherapie
COPA-R-CHOP,
Kitty Leuschel 0341 9713133
UKM18_0021
A prospective multicenter phase 2 study of the combination
of the phosphatidylinositol-3-kinase inhibitor copanlisib
in combination with rituximab and CHOP chemotherapy
(COPA-R-CHOP) in patients with previously untreated diffuse
large B-cell lymphoma (DLBCL)
Rezidiv, refraktär
MOR208C204 -
Kitty Leuschel 0341 9713133
B-MIND
A phase II/III, randomized, multicentre study of MOR00208
with Bendamustine versus Rituximab with Bendamustine
in patients with relapsed or refractory diffuse large b-cell
lymphoma (R-R DLBCL) who are not eligible for high-dose
chemotherapy (HDC) and autologous stem-cell transplantation
(ASCT) - B-MIND
AFM13-202,
REDIRECT Kitty Leuschel 0341 9713133
107652
A phase II open-label multicenter study to assess the efficacy
and safety of AFM13 in patients with relapsed or refractory
CD30-positive Peripheral T-Cell Lymphoma or transformed
mycosis fungoides (REDIRECT)
22R1979-
Katja Hammann 0341 9713131
ONC-1625
An open-label study to assess the anti-tumor activity and
safety of REGN1979, an Anti-CD20 X Anti-CD3 bispecific
antibody, in patients with relapsed or refractory B-cell non-
hodgkin lymphoma
Rezidiv, refraktär –
Early Clinical Trials Unit Leipzig
MK4280-003 Karolin Hubert 0341 9720363
A phase 1b clinical study to evaluate safety and efficacy of
a combination of MK-4280 an Prembrolizumab (MK-3475)
in participants with hematologic malignancies
CC-220-
Karolin Hubert 0341 9720363
NHL-001
A phase 1, multicenter, open-label study to assess safety,
pharmacokinetics, and preliminary efficacy of Iberdomide
(CC-220), alone and in combination with anti-CD20 in
subjects with relapsed or refractory lymphomas
ALL
Primärtherapie
GMALL
Kitty Leuschel 0341 9713133
08/2013
Multizentrische randomisierte Studie zur Risiko- und
subgruppenadaptierten Therapieoptimierung bei
Erwachsenen mit ALL oder lymphoblastischen Lymphomen
(Phase IV-Studie mit einem Phase III-Teil zur Evaluation der
Sicherheit und Wirksamkeit von Nelarabin bei T-ALL)
EWALL-BOLD Kitty Leuschel 0341 9713133
Phase II trial for the treatment of older patients with newly
diagnosed CD19 positive, Ph/BCR-ABL negative B-precursor
acute lymphoblastic leukemia with sequential dose reduced
chemotherapy and Blinatumomab
Rezidiv, refraktär
GMALL-
MOLACT1- Kitty Leuschel 0341 9713133
BLINA
A multicenter, single-arm study to assess the efficacy, safety,
and tolerability of the BiTE® antibody Blinatumomab in adult
patients with minimal residual disease (MRD) of B-precursor
acute lymphoblastic leukemia (Blast Successor Trial), phase II
23Rezidiv, refraktär –
Early Clinical Trials Unit Leipzig
20180257 Karolin Hubert 0341 9720363
A phase 1b open-label study to investigate the safety
and pharmacokinetics of administration of subcutaneous
Blinatumomab for the treatment of adults with relapsed or
refractory B cell precursor acute lymphoblastic leukemia
(R/R B-ALL)
Hodgkin Lymphom
Primärtherapie
HD21 Katja Hammann 0341 9713131
HD21- Therapieoptimierungsstudie für Patienten mit
Erstdiagnose eines fortgeschrittenen klassischen Hodgkin
Lymphoms: eine randomisierte Phase 3 Studie
Rezidiv
ADCT-301-201 Katja Hammann 0341 9713131
A phase 2, open-label, single-arm study to evaluate the
efficacy and safety of Camidanlumab Tesirine (ADCT-301) in
patients with relapsed or refractory hodgkin lymphoma
Rezidiv –
Early Clinical Trials Unit Leipzig
MK4280-003 Karolin Hubert 0341 9720363
A phase 1b clinical study to evaluate safety and efficacy of
a combination of MK-4280 an Prembrolizumab (MK-3475)
in participants with hematologic malignancies
Stammzelltransplantation
MOZOBL08363/
Katja Hammann 0341 9713131
OPTIMOB
Eine deutschlandweite systematische Untersuchung der
Mobilisierung und Sammlung von hämatopoetischen
Stammzellen bei schlecht mobilisierbaren Patienten vor
autologer Stammzelltransplantation
24JZP-381 15-007
Kitty Leuschel 0341 9713133
(VOD)
A phase 3, randomized, adaptive study comparing the
efficacy and safety of Defibrotide vs. best supportive care
in the prevention of hepatic veno-occlusive disease in adult
and pediatric patients undergoing hematopoietic stem cell
transplant
Graft versus Host Disease
INCB 39110-
309 / Katrin Stolle 0341 9713134
GRAVITAS
A phase 3 study of Itacitinibor placebo in combination with
corticosteroids as initial treatment for chronic graft versus host
disease (GRAVITAS 309)
MC-MSC.1
Katrin Stolle 0341 9713134
IDUNN
A randomised, open-label, multicentre, phase 3 trial
of first-line treatment with mesenchymal stromal cells
MC0518 versus best available therapy in adult and
adolescent subjects with steroid-refractory acute graft-versus
host disease after allogeneic haematopoietic stem cell
transplantation / IDUNN
CMV
SHP620-302
Kitty Leuschel 0341 9713133
AURORA
A phase 3, multicenter, randomized, double-blind, double-
dummy, active-controlled study to assess the efficacy
and safety of Maribavir compared to Valganciclovir
for the treatment of cytomegalovirus (CMV) infection in
hematopoietic stem cell transplant recipients
MCL
TRIANGLE Katrin Stolle 0341 9713134
Autologous transplantation after a Rituximab/Ibrutinib/Ara-C
containing induction in generalized mantle-cell lymphoma - a
randomized European MCL Network Trial
25Zelltherapie
Lymphom
M-2016-312,
Kitty Leuschel 0341 9713133
CART20.1
A phase I/II safety, dose finding and feasibility trial of MB-
CART20.1 in MB patients with relapsed or resistant CD20
positive B-NHL
Multiples Myelom
64007957
Karolin Hubert 0341 9720363
MMY1001
A phase 1/2, first-in-human, open-label, dose escalation
study of Teclistamab, a humanized BCMA x CD3 bispecific
antibody, in subjects with relapsed or refractory multiple
myeloma
68284528
MMY3002 Jenny Dietrich 0341 9720364
Cartitude4
A phase 3 randomized study comparing JNJ-68284528, a
Chimeric Antigen Receptor T cell (CAR-T) therapy directed
against BCMA vs Carfilzomib and Dexamethasone (Kd) or
Daratumumab, Pomalidomide and Dexamethasone (DPd)
in Participants with relapsed and Lenalidomide-refractory
multiple myeloma
Early Clinical Trials Unit Leipzig
UC02-123-01 Karolin Hubert 0341 9720363
Multizentrische, offene Phase I Studie mit Dosissteigerungen
für die Behandlung von Patienten mit CD123 positiven
hämatologischen und lymphatischen Malignomen mittels
gentechnisch veränderten T-Zellen, die universelle chimäre
Antigen-Rezeptoren (UniCAR02-T) auf der Oberfläche tragen,
und in Kombination mit einem CD123-spezifischen Zielmodul
(TM123) verabreicht werden
psychoonkologische Versorgung
SALUT Dr. Peter Esser 0341 9718800
Trauma- und belastungsbezogene Störungen bei
hämatologischen Krebspatienten: Eine Interview-basierte
Studie anhand aktualisierter diagnostischer Kriterien
26Dr. Diana Richter/ 0341 9715426/
Peer2Me
Dr. Kristina Geue 0341 9715438
Peer2Me 2.0 – Evaluation eines Peer-MentoringProgramms
zur Unterstützung junger Erwachsener mit Krebs
Prof. Dr. phil. Anja
LUPE 0341 9718800
Mehnert-Theuerkauf
Längsschnittanalyse des psychoonkologischen
Unterstützungsbedarfs bei Patienten und deren Angehörigen
stratifiziert nach biopsychosozialen Einflussfaktoren
Prof. Dr. phil. Anja
OptiScreen 0341 9718800
Mehnert-Theuerkauf
Optimierte psychoonkologische Versorgung durch einen
interdisziplinären Versorgungsalgorhytmus – vom Screening
zur Intervention
AYA-LE
Dr. Kristina Geue 0341 9715438
Längsschnitt 2
Peer2Me 2.0 – Evaluation eines Peer-Mentoringprogramms
zur Unterstützung junger Erwachsener mit Krebs
Prof. Dr. phil. Anja
AOK 0341 9718800
Mehnert-Theuerkauf
Entwicklung eines Online-Coaches für Angehörige von an
Krebs erkrankten Menschen
Prof. Dr. phil. Anja
OnkoDigitrial 0341 9718800
Mehnert-Theuerkauf
OnkoDigitrial – digitale Begleitung von Patient:innen mit
Krebserkrankung für eine nachhaltige Verbesserung der
Lebensqualität
Prof. Dr.
QualityOfLife 0341 9718820
Andreas Hinz
Gesundheitsbezogene Lebensqualität in der Onkologie und
Palliativmedizin: Die Beziehung zwischen Wichtigkeits- und
Zufriedenheitsurteilen
Dr. Kristina Geue/
0341 9715438/
ONKO-STEP Prof. Dr. phil. Anja
0341 9718800
Mehnert-Theuerkauf
Wirksamkeit der kognitiv-behavioralen Online-
Schreibtherapie Onko-STEP für Krebspatienten im jungen
Erwachsenenalter – eine randomisierte kontrollierte Studie
27ALL Pädiatrie
Primärtherapie
AIEOP-BFM ALL
Kerstin Faulhaber 0341 9726173
2017
Internationales kooperatives Behandlungsprotokoll Kinder
und Jugendliche mit Akuter lymphatischer Leukämie
EsPhALL2017/
Kerstin Faulhaber 0341 9726173
COGAALL1631
Internationale Therapiestudie zur Behandlung von
Kindern und Jugendlichen mit Philadelphia-positiver Akuter
Lymphoblastischer Leukämie
Rezidiv
IntReALL HR
Kerstin Faulhaber 0341 9726173
2010
International study for treatment of high risk childhood
relapsed ALL 2010
ALL-REZ BFM
Kerstin Faulhaber 0341 9726173
Register
Beobachtungsstudie und Biobank für Rezidive einer akuten
lymphatischen Leukämie im Kindes-und Jugendalter
AML Pädiatrie
Register
AML-BFM 2017 Kerstin Faulhaber 0341 9726173
Register zur Erfassung der myeloischen Leukämien bei
Kindern und Jugendlichen
CML Pädiatrie
Primärtherapie
CML-paed-II-
Kerstin Faulhaber 0341 9726173
Register
Protocol for standardized diagnostic procedures, registration,
and treatment recommendations in children and adolescents
with philadelphia chromosome-positive chronic myeloid
leukemia (CML)
28MDS Pädiatrie
Primärtherapie
EWOG-
Kerstin Faulhaber 0341 9726173
MDS-2006
Prospective non randomized multicenter study for
epidemiology and characterization of myelodysplastic
syndromes (MDS) and juvenile myelomonocytic leukemia
(JMML) in childhood
Lymphom Pädiatrie
Primärtherapie
B-NHL 2013 Kerstin Faulhaber 0341 9726173
Treatment protocol of the NHL-BFM and the NOPHO study
groups for mature aggressive B-cell lymphoma and leukemia
in children and adolescents
LBL 2018 Kerstin Faulhaber 0341 9726173
International cooperative treatment protocoll for children and
adolescents with lymphoblastic lymphoma
Neuroblastome Pädiatrie
Primärtherapie
Neuroblastom-
Kerstin Faulhaber 0341 9726173
Register
Erfassung von Säuglingen, Kindern und Jugendlichen und
jungen Erwachsenen mit neu diagnostizierten und/oder
Rückfall eines neuroblastischen Tumors
Rezidiv
Metro-NB 2012 Kerstin Faulhaber 0341 9726173
Metronomische Behandlung von Kindern und Jugendlichen
mit rezidiviertem oder progredientem Neuroblastom
Nephroblastome Pädiatrie
Primärtherapie
SIOP 2001/
Kerstin Faulhaber 0341 9726173
GPOH
Chemotherapy before and after surgery in treating children with
Wilm‘s Tumor
29Hepatoblastome Pädiatrie
PHITT Studie Kerstin Faulhaber 0341 9726173
Paediatric hepatic international tumor trial
Hirntumore Pädiatrie
Primärtherapie
CPT-SIOP-2009 Kerstin Faulhaber 0341 9726173
Intercontinental multidisciplinary registry and treatment
optimization study for patients with choroid plexus tumors
Kraniopharyn-
geom Register Kerstin Faulhaber 0341 9726173
2019
Multicenter registry for patients with childhood-onset
craniopharyngioma, xanthogranuloma, cysts of Rathke’s pouch,
meningioma, pituitary adenoma, arachnoid cysts
SIOP
Kerstin Faulhaber 0341 9726173
Ependymoma II
An international clinical program for the diagnosis and treatment
of children, adolescents and young adults with ependymoma
I-HIT-Med Kerstin Faulhaber 0341 9726173
For children, adolescents, and adults with medulloblastoma,
ependymoma, pineoblastoma, CNS-primitive neuroectodermal
tumours
EU-RHAB Kerstin Faulhaber 0341 9726173
A multinational registry for rhabdoid tumors of any anatomical
site
SIOP PNET 5
Kerstin Faulhaber 0341 9726173
MB-LR und -SR
Internationale, prospektive, randomisierte (SR) Phase II/III-
Studie für Kinder älter als 3-5 Jahren und jünger als 16.0 Jahre
(LR) bzw. geringer als 22.0 Jahre (SR) mit einem klinischen
Standardrisiko-Medulloblastom und niedrigem (LR) bzw.
durchschnittlichem (SR) biologischen Risikoprofil
30HIT-HGG-2013 Kerstin Faulhaber 0341 9726173
International cooperative phase III trial of the HIT-HGG study
group for the treatment of high grade glioma, diffuse intrinsic
pontine glioma, and gliomatosis cerebri in children and
adolescents < 18 years
HIT-LOGGIC
Kerstin Faulhaber 0341 9726173
Register
Prospektives multizentrisches Register für Kinder- und Jugendliche
mit einem niedrig-gradigen Gliom
Rezidiv
HIT-REZ Register Kerstin Faulhaber 0341 9726173
Multinationales multizentrisches Register für Kinder, Jugendliche
und junge Erwachsene mit therapierefraktären oder rezidivierten
Medulloblastomen, Pineoblastomen, primitiv neuroektodermalen
Tumoren des ZNS (ZNS-PNET´s) und Ependymomen
Sarkome Pädiatrie
Primärtherapie
CWS 2007-HR Kerstin Faulhaber 0341 9726173
Trial for localised high-risk rhabdomyosarcoma and
rhabdomyosarcoma-like soft tissue sarcoma
rEECur Kerstin Faulhaber 0341 9726173
International randomised controlled trial for the treatment of
recurrent and primary refractory ewing sarcoma
CWS-Register
Kerstin Faulhaber 0341 9726173
SoTiSaR
A registry for soft tissue sarcoma and other soft tissue tumours in
children, adolescents, and young adults
COSS-Register Kerstin Faulhaber 0341 9726173
Register der Cooperativen Osteosarkomstudiengruppe COSS
Keimzelltumore
Makei V Kerstin Faulhaber 0341 9726173
Multizentrische prospektive Studie zu einem randomisierten
Vergleich von Carboplatin mit Cisplatin bei extrakraniellen
malignen Keimzelltumoren
31Seltene Tumore Pädiatrie
GPOH-MET Kerstin Faulhaber 0341 9726173
Register zur Erfassung maligner endokriner Tumoren im Kindes-
und Jugendalter
STEP Kerstin Faulhaber 0341 9726173
Seltene Tumoren, die nicht in prospektive Behandlungsstudien
oder Register der GPOH eingeschlossen werden
INFORM Kerstin Faulhaber 0341 9726173
Individualized therapy for relapsed malignancies in childhood
Lebertumor-
Kerstin Faulhaber 0341 9726173
register
Register für Lebertumoren bei Kindern und Jugendlichen
NPC-2016 Kerstin Faulhaber 0341 9726173
A multicenter registry of nasopharyngeal cancer in children,
adolescents and young adults
Retinoblastom-
Kerstin Faulhaber 0341 9726173
register
Register für die Retinoblastomerkrankung in Deutschland und
Österreich
32NOTIZEN
33NOTIZEN 34
NOTIZEN
35NOTIZEN 36
NOTIZEN
37Ansprechpartner/Kontakt Dr. Ivonne Haffner Universitätsklinikum Leipzig Leitung klinische Forschung Liebigstraße 22, Haus 7; 04103 Leipzig Tel.: 0341 9712570 E-Mail: studienzentrale.uccl@medizin.uni-leipzig.de Studien durchführende Einheiten am Universitätsklinikum Leipzig Universitäres Krebszentrum Leipzig (UCCL) Direktor Prof. Dr. Florian Lordick Klinik und Poliklinik für Strahlentherapie Direktor Prof. Dr. Rolf-Dieter Kortmann Klinik und Poliklinik für Neurochirurgie Direktor Prof. Dr. Jürgen Meixensberger Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie Direktor Prof. Dr. Jan C. Simon Medizinische Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie, Pneumologie und Infektiologie (II) komm. Direktor Prof. Dr. Thomas Berg Klinik und Poliklinik für Urologie Direktor Prof. Dr. Jens-Uwe Stolzenburg Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde Direktor Prof. Dr. Andreas Dietz Klinik und Poliklinik für Frauenheilkunde Direktorin Prof. Dr. Bahriye Aktas Klinik und Poliklinik für Viszeral-, Transplantations-, Thorax- und Gefäßchirurgie Direktoren Prof. Dr. Ines Gockel (Viszeralchirurgie) und Prof. Dr. Daniel Seehofer (Hepatobiliäre Chirurgie) Medizinische Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie (I) Direktoren Prof. Dr. Uwe Platzbecker und Prof. Dr. Florian Lordick Abteilung für Pneumologie Leiter Prof. Hubert Wirtz Abteilung Medizinische Psychologie und Medizinische Soziologie Leiterin Prof. Dr. Anja Mehnert-Theuerkauf Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie Leiter Prof. Dr. Holger Christiansen
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