NCT02665143View on ClinicalTrials.gov

A Randomized Trial of a Combination of Nintedanib/Placebo in Combination With Induction Chemotherapy for Patients With Refractory or First Relapse Acute Myeloid Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

July 21, 2016

Primary Completion Date

March 8, 2021

Study Completion Date

March 30, 2021

Conditions
Relapsed/Refractory Acute Myeloid Leukemia
Interventions
DRUG

Nintedanib and AML induction

The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. In the phase I part, all patients will receive the combination with Nintedanib 200mg bid begun at day 8 and continued until end of cycle. If a significant incidence of dose limiting toxicities is demonstrated, Nintedanib will be given at a lower dose level (150mg bid).

Trial Locations (2)

37232

Vanderbilt Ingram Cancer Center, Nashville

06520

Yale University, New Haven

All Listed Sponsors
collaborator

Vanderbilt University

OTHER

lead

Yale University

OTHER

NCT02665143 - A Randomized Trial of a Combination of Nintedanib/Placebo in Combination With Induction Chemotherapy for Patients With Refractory or First Relapse Acute Myeloid Leukemia | Biotech Hunter | Biotech Hunter