Trial of Intensive Chemotherapy With or Without Volasertib in Patients With Newly Diagnosed High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
NCT02198482 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2018-02-28
Summary
Randomized Phase II Trial of Intensive Chemotherapy With or Without Volasertib (BI 6727) in Patients With Newly Diagnosed High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
Conditions
- Acute Myeloid Leukemia (AML)
- High-risk Myelodysplastic Syndrome (MDS)
Interventions
- DRUG
-
Volasertib
- DRUG
- DRUG
-
Daunorubicin
- DRUG
-
Mitoxantrone
Sponsors & Collaborators
-
University of Ulm
lead OTHER
Principal Investigators
-
Hartmut Döhner, Prof. Dr. · AMLSG Clinical Trials Office
-
Peter Paschka, MD · University Hospital Ulm
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-02-29
- Primary Completion
- 2016-11-30
- Completion
- 2016-11-30
Countries
- Germany
Study Locations
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