Trial of Intensive Chemotherapy With or Without Volasertib in Patients With Newly Diagnosed High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)

NCT02198482 ↗

Phase 2 Terminated 6 enrolled University of Ulm

RandomizedParallel-groupOpen-labelTreatment

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)

Timeline

Start: 2016-02
Primary completion: 2016-11
Completion: 2016-11

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Volasertib	Small molecule	—	Intravenous
Background	Cytarabine	Small molecule	100 mg/m2	Intravenous
Background	Cytarabine	Small molecule	1000 mg/m2	Intravenous
Background	Cytarabine	Small molecule	1500 mg/m2	Intravenous
Background	Daunorubicin	Small molecule	50 mg/m2	Intravenous
Background	Daunorubicin	Small molecule	60 mg/m2	Intravenous
Background	Mitoxantrone	Small molecule	8 mg/m2	Intravenous
Background	Mitoxantrone	Small molecule	10 mg/m2	Intravenous

Trial of Intensive Chemotherapy With or Without Volasertib in Patients With Newly Diagnosed High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)

Summary

Timeline

Drugs

Indications