Phase I/II Study of the Combination of Dasatinib With Chemotherapy for High Risk Acute Myeloid Leukemia (AML) Patients
PRIMARY OBJECTIVES:
I. Of the dose levels studied, to determine the maximum tolerated dose of dasatinib when
given in combination with cytarabine and idarubicin for treatment of high risk acute myeloid
leukemia (AML). (Phase I) II. To determine the anti-tumor activity of dasatinib when given
in combination with cytarabine and idarubicin, as assessed by complete remission rate (CR)
and remission duration. (Phase II)
SECONDARY OBJECTIVES:
I. To document CR and survival outcomes (overall, event-free). (Phase I) II. To estimate the
survival probabilities (overall and event-free) and cumulative incidence of
relapse/progression. (Phase II) III. To describe and summarize all toxicities by organ and
severity. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of dasatinib, followed by a phase II
study.
Patients receive cytarabine intravenously (IV) continuously over 168 hours on days 1-7,
dasatinib orally (PO) once daily (QD) on days 1-7, and idarubicin IV on days 1-3. Patients
with non-responsive disease on day 30 may receive a second course of therapy in the absence
of unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days and then every 2
months for up to 2 years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of dasatinib, determined according to incidence of dose limiting toxicity (DLT), graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
Up to 42 days
Yes
Ahmed Aribi
Principal Investigator
City of Hope Medical Center
United States: Federal Government
12393
NCT01876953
August 2013
Name | Location |
---|---|
City of Hope Medical Center | Duarte, California 91010 |