Treatment of MDS/AML Patients With an Impending Hematological Relapse With AZA or ATA and Pevonedistat
NCT04712942 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2023-08-21
Summary
MDS/AML with MRD and impending relapse after allogeneic stem cell transplantation and/or conventional chemotherapy
Conditions
- Acute Myeloid Leukemia in Remission
- Myelodysplastic Syndromes
- Minimal Residual Disease
Interventions
- DRUG
-
Pevonedistat
Patients receive pevonedistat at 20 mg/m2 i.v. (d1,3,5, q4w) up to 12 cycles
- DRUG
-
azacitidine is given at a standard dose of 75 mg/m² (d1-7 or 1-5,8,9, q4w) up to 12 cycles
Sponsors & Collaborators
-
Millennium Pharmaceuticals, Inc.
collaborator INDUSTRY -
University of Leipzig
lead OTHER
Principal Investigators
-
Uwe Platzbecker, Prof. Dr. · University Leipzig
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-01-01
- Primary Completion
- 2023-01-31
- Completion
- 2023-01-31
Countries
- Germany
Study Locations
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