NCT01174888 - Phase I Combination of Midostaurin, Bortezomib, and Chemo in Relapsed/Refractory Acute Myeloid Leukemia | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

April 30, 2014

Study Completion Date

May 31, 2016

Conditions

Acute Myeloid LeukemiaAcute Myeloid Leukemia With Multilineage Dysplasia FollowingMyelodysplastic SyndromeAdult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Del(5q)Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Recurrent Adult Acute Myeloid LeukemiaSecondary Acute Myeloid Leukemia

Interventions

DRUG

midostaurin

Drug midostaurin, Given orally given twice daily days 1-14

DRUG

Bortezomib

Bortezomib given IV on days 1, 4, 8, and 11

DRUG

mitoxantrone hydrochloride

Patients receive mitoxantrone hydrochloride IV over 10 minutes

DRUG

etoposide

Patients receive etoposide IV over 1 hour

DRUG

cytarabine

Patients receive cytarabine IV over 6 hours on days 1-6

Trial Locations (1)

43210

The Ohio State University Medical Center, Columbus