Übersicht der Deutschen MDS-Studiengruppe

teilnehmende Zentren variieren (Stand: 2018)

Clinical Studies

Short Title Phase Title
AMLSG 19-13/ARO-007 Phase 3 Dose-Finding Run-in Phase I Followed by a Phase III, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of Crenolanib in Combination With Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Activating FLT3 Mutations
AZA-JMML-001 Phase 2 A Phase 2, multicenter, open-label study to evaluate the pharmacokinetics, pharmacodynamics, safety and activity of azacitidine and to compare azacitidine to historical controls in pediatric subjects with newly diagnosed advanced myelodysplastic syndrome or juvenile myelomonocytic leukemia before hematopoietic stem cell transplantation.
ClAraC-SCT Phase 2 Randomized, Multi-centre, Phase II Trial to Compare the Event-Free Survival of Clofarabine / Ara-C (ClAraC) or of FLAMSA Treatment in Patients With High Risk AML or Advanced MDS Scheduled for Allogeneic Stem Cell Transplantation
CLGH447X2102 (oral LGH447) Phase 1 A Phase I, Multicenter, Open-label Study of Oral LGH447 in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
D-00272-CT2014002 Phase 1/2 Single Arm Phase I/II Study of the Safety and Efficacy of Gene-modified WT1 TCR Therapy in Patients With Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukaemia (AML) Who Have Failed to Achieve or Maintain an IWG Defined Response Following Hypomethylating Agent Therapy.
DACOTA Phase 3 A Randomized Phase III study of Decitabine with or without Hydroxyurea versus Hydroxyurea in patients with advanced proliferative Chronic Myelomonocytic Leukemia (GFM-DAC-CMML)
EQol-MDS Phase 2 Eltrombopag for the treatment of thrombocytopenia due to low- and intermediate risk myelodysplastic syndromes.
EUROPE Phase 2 Prospective validation of a predictive model of response to romiplostim in patients with IPSS low or intermediate-1 risk myelodysplastic syndrome (MDS) and thrombocytopenia – the EUROPE trial.
H3B-8800-G000-101 Phase 1 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
IMerge Phase 2/3 Study to Evaluate Imetelstat (JNJ-63935937) in Subjects With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
M15-531 (Venetoclax + AZA) (recruitment completed > Follow-up) Phase 2 A Phase 1b Dose Escalation Study Evaluating the Safety and Pharmacokinetics of Venetoclax in Combination With Azacitidine in Subjects With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)
MEDALIST Phase 3 A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Placebo for the Treatment of Anemia Due to the IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in Subjects With Ring Sideroblasts Who Require Red Blood Cell Transfusions.
MEDI4736-MDS-001 (Durvalumab + AZA) Phase 2 A Randomized, Multicenter, Open-label, Phase 2 Study Evaluating the Efficacy and Safety of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Subjects With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly (>= 65 Years) Acute Myeloid Leukemia (AML) Subjects Not Eligible for Hematopoietic Stem Cell Transplantation (HSCT)
Pevonedistat-2001 (recruitment completed > Follow-up) Phase 2 A Phase 2, Randomized, Controlled, Open-Label, Clinical Study of the Efficacy and Safety of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myelogenous Leukemia
QUAZAR (AZA-MDS-003) (recruitment completed > Follow-up) Phase 3 A Phase 3, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Subjects With Red Blood Cell Transfusion-dependent Anemia and Thrombocytopenia Due to IPSS Lower-risk Myelodysplastic Syndromes
RELAZA2 Phase 2 Treatment of Patients With MDS or AML With an Impending Hematological Relapse With Azacitidin (Vidaza)
SAMBA (on hold) Phase 2 Single agent JNJ-56022473 in MDS and AML patients failing hypomethylating agentbased therapy
SINTRA-REV Phase 3 Multicenter, randomized, double-blind, phase III study of Revlimid® (Lenalidomide) versus placebo in patients with low risk myelodysplastic syndrome (low and intermediate-1 IPSS) with alteration in 5q- and anaemia without the need of transfusion.
TRANSATRA Phase 1/2 Phase I/II Study of Sensitization of Non-M3 Acute Myeloid Leukemia (AML) Blasts to All-trans Retinoic Acid (ATRA) by Epigenetic Treatment With Tranylcypromine (TCP), an Inhibitor of the Histone Lysine Demethylase 1 (LSD1) (TRANSATRA)
VidazaAlloStudie Phase 2 Randomized, Multi-centre, Phase II Trial to Compare the Event-Free Survival of Clofarabine / Ara-C (ClAraC) or of FLAMSA Treatment in Patients With High Risk AML or Advanced MDS Scheduled for Allogeneic Stem Cell Transplantation


Registries / Non-Interventional Studies / Phase 4

Short Title Phase Title
AMLSG Bio Registry Study NIS / Registry Registry Study on Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms, and Acute Leukemias of Ambiguous Lineage The AMLSG Biology and Outcome (BiO)-Project
BOHEME NIS / Registry A Prospective Longitudinal Cohort Study to Investigate the Interactions of Bone and Hematopoiesis in the Elderly
CD34+FISH+SNP-Studie NIS / Registry CD34+FISH+SNP: Sequential comprehensive genetic analysis of circulating CD34+ cells in MDS.
EUMDS NIS / Registry A Prospective, Multicenter European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes of IPSS Low and Intermediate-1 Subtypes (expanded inclusion: IPSS high or Intermediate-2 Subtypes)
EXCALIBUR Phase 4 / PASS Eine prospektive nicht intervenionelle Studie zur Eisenchelattherapie von Patienten mit chronischer Eisenüberladung
MDS-Registry (Düsseldorf) Registry Registry on MDS capturing data on clinical, hematologic, morphologic, cytogenetic, and molecular findings, progression, therapeutic interventions, and causes of deaths
PASS MDS del5q Phase 4 / PASS A Post-authorization, Non-interventional, Safety Study Study of Patients With Myelodysplastic Syndromes (MDS) Treated With Lenalidomide.
PROMYS NIS / Registry Prognostic Significance and Longitudinal Assessment of Patient-reported Quality of Life and Symptoms in Myelodysplastic Syndromes. A Large-scale International, Observational Study: PROMYS Study