Benutzerspezifische Werkzeuge

Akute Leukämien

GRASPA-AML

A Multicentre, open, randomized, controlled phase IIb trial evaluating efficacy and tolerability of GRASPA (L-asparaginase encapsulated in red blood cells) plus low-dose cytarabine vs low-dose cytarabine alone, in treatment of newly diagnosed acute myeloid leukemia (AML) patients, over 65 years, unfit for intensive chemotherapy.

A Multicentre, open, randomized, controlled phase IIb trial evaluating efficacy and tolerability of GRASPA (L-asparaginase encapsulated in red blood cells) plus low-dose cytarabine vs low-dose cytarabine alone, in treatment of newly diagnosed acute myeloid leukemia (AML) patients, over 65 years, unfit for intensive chemotherapy.


Hauptprüfer Dresden: PD Dr. med. Christoph Röllig
Studiensekretariat: Una Wendler Tel: +49 351 4589463


AC220-007

A PHASE 3 OPEN-LABEL RANDOMIZED STUDY OF QUIZARTINIB (AC220) MONOTHERAPY VERSUS SALVAGE CHEMOTHERAPY IN SUBJECTS WITH FLT3-ITD POSITIVE ACUTE MYELOID LEUKEMIA (AML) REFRACTORY TO OR RELAPSED AFTER FIRST-LINE TREATMENT WITH OR WITHOUT HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT) CONSOLIDATION

A PHASE 3 OPEN-LABEL RANDOMIZED STUDY OF QUIZARTINIB (AC220) MONOTHERAPY VERSUS SALVAGE CHEMOTHERAPY IN SUBJECTS WITH FLT3-ITD POSITIVE ACUTE MYELOID LEUKEMIA (AML) REFRACTORY TO OR RELAPSED AFTER FIRST-LINE TREATMENT WITH OR WITHOUT HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT) CONSOLIDATION


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Hauptprüfer Dresden: Prof. Dr. med. Martin Bornhäuser
Studiensekretariat: Tel: +49 351 458 12091


DELTA

A randomized placebo-controlled phase 2 study of decitabine with or without eltrombopag in AML patients ≥65 years of age not eligible for intensive chemotherapy Randomisierte, Placebo-kontrollierte Phase-II-Studie für Decitabin mit oder ohne Eltrombopag bei älteren Patienten mit neu diagnostizierter akuter myeloischer Leukämie für die eine intensive Chemotherapie nicht in Frage kommt


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Hauptprüfer Dresden:
Tel: 5197


BLAST, BL-8040 in consolidation therapy

A double- blind, placebo controlled, randomized, multicenter, Phase II study to assess the efficacy of BL-8040 Addition to conSolidation Therapy in AML patients.


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Hauptprüfer Dresden: Dr. Friedrich Stölzel
Studiensekretariat: Annett Engmann Tel: +49 351 4584969


Mirros

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PHASE III STUDY OF IDASANUTLIN, AN MDM2 ANTAGONIST, WITH CYTARABINE VERSUS CYTARABINE PLUS PLACEBO IN PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML)


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Hauptprüfer Dresden: PD Dr. med. Christoph Röllig
Studiensekretariat: Ines Böde Tel: +49 351 4585616


AML004

A Phase 3, Multicenter, Open-label, Randomized Study Comparing the Efficacy and safety of AG-221 (CC-90007) Versus Conventional Care Regimes in Older Subjects with late Stage of Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation


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Hauptprüfer Dresden: PD Dr. med. Christoph Röllig
Tel: +49 351 4582541


GMALL08/2013

Therapieoptimierung bei erwachsenen Patienten mit neu diagnostizierter akuter lymphatischer Leukämie (ALL) oder lymphoblastischem Lymphom (LBL) durch individualisierte, gezielte und intensivierte Therapie


Hauptprüfer Dresden: Dr. Nael Alakel
Tel: +49 351 4585222


GMALL-MOLACT1-BLINA

A confirmatory 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)


Hauptprüfer Dresden: Dr. Nael Alakel
Tel: +49 351 4585222


BI 1315.2

An open-label, Phase I/II trial to determine the maximum tolerated dose and investigate safety, pharmacocinetics and efficacy of BI 836858 in combination with decitabine in patients with acute myeloid leukemia.


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Hauptprüfer Dresden: Dr. med. Jan Moritz Middeke
Studiensekretariat: Tel: +49 351 458 12091


MEDI 4736-MDS-001

A Randomized, Multicenter, Open- Label, Phase 2 Study Evaluating The Efficacy And Safety Of Azacitidine Subcutanous In Combination With Durvalumab (MEDI 4736) In Previously Untreated Subjects With Higher- Risk Myelodysplastic Syndromes (MDS) Or In Eldery (> 65 Years) Acute Myeloid LeuKemia (AML) Subjects Not Eligible For Hematopoietic Stem Cell Transplantation (HSCT)


Hauptprüfer Dresden: Dr. Katja Sockel
Studiensekretariat: Tel: +49 351 458 12091


Astellas2215

A Phase 3 Open-label, Multicenter, Randomized Study of ASP2215 versus Salvage Chemotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) with FLT3 Mutation


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Hauptprüfer Dresden: PD Dr. med. Christoph Röllig
Studiensekretariat: Susann Hollstein Tel: +49 351 4584535


SAMBA

Single Agent JNJ-56022473 in MDS and AML Patients failing hypomethylating agent based therapy


Hauptprüfer Dresden:
Tel: 5197


H3 Biomedicine

An Open-label, Multicenter Phase 1 Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Splicing Modulator H3B-8800 for Subjects With Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia.


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Hauptprüfer Dresden: Prof. Dr. Uwe Platzbecker
Studiensekretariat: Tel: 0351/45817520


INITIAL-1

An open label phase II study to evaluate the efficacy and safety of Inotuzumab Ozogamicin for Induction Therapy followed by a conventional chemotherapy based consolidation and maintenance therapy In patients aged 55 years and older with Acute Lymphoblastic leukemia (ALL)


Hauptprüfer Dresden: Dr. Nael Alakel
Tel: +49 351 4585222


HAMLET

A randomized controlled trial comparing outcome after hematopoietic cell transplantation from a partially matched unrelated versus haploidentical donor


Hauptprüfer Dresden: PD Dr. Johannes Schetelig
Studiensekretariat: Sandra König Tel: +49 351 4587572


Philogen PH-F16IL2CD33-03/15

A Phase I study of the tumor-targeting human F16IL2 monoclonal antibody-cytokine fusion protein in combination with the anti-CD33 antibody BI 836858 in patients with AML relapse after allogeneic hematopoietic stem cell transplantation.


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Hauptprüfer Dresden:
Studiensekretariat: Tel: 0351/45819648


GEM333

A Multicenter, Open-label, Dose-escalating, Phase I Trial with GEM333, a CD33 Targeted Bispecific Anti-body Engaging T-cells, in Relapsed or Refractory acute Myeloid Leukemia.


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Hauptprüfer Dresden:
Studiensekretariat: Tel: 0351/45817566


BERGAMO

Phase 2-Studie zur Untersuchung der Wirksamkeit und Sicherheit von Bemcentinib bei MDS- und AML-Patienten, die kein Ansprechen auf Standardtherapien zeigen


Hauptprüfer Dresden: Dr. Katja Sockel
Studiensekretariat: Lisa Deutsch Tel: 3089


Novartis CPDR001X2105

Phase 1b, multi-arm, open-label study of PDR001 and/or MBG453 in combination with decitabine in patients with acute myeloid leukemia or high risk myelodysplastic syndrome.


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Hauptprüfer Dresden:
Studiensekretariat: Tel: 0351/45819648