A Phase I/II Study of Ribavirin and Low-dose Cytarabine Arabinoside (Ara-C) in Acute Myeloid Leukemia (AML) M4 and M5 Subtypes, and AML With High eIF4E Expression
Primary Objectives
In the Phase I portion of this study, we will determine the maximum tolerated dose and
recommended phase II dose (RP2D) of ribavirin and low-dose ara-C. The primary objective of
the Phase II portion of the study is to determine the overall response rate, including the
complete remission (CR), complete remission with incomplete blood count recovery (CRi),
partial remission (PR) or blast response (BR), to therapy with ribavirin and low dose ara-C
at the RP2D.
STUDY DESIGN AND DURATION
This is a multicentre, open-label, single arm Phase I/II study of oral ribavirin and
low-dose ara-C for patients with AML M4/M5 or AML with high expression of eIF4E, who have
relapsed or refractory disease, or who are not suitable candidates for induction
chemotherapy. This study will determine the recommended phase II dose and will evaluate
efficacy. Correlative studies will be included to assess relevant molecular targets.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Recommended phase II dose of ribavirin when given in combination with low-dose ara-C
6-9 months
Yes
Sarit Assouline, MD
Principal Investigator
Jewish General Hospital, McGill University
Canada: Health Canada
Ribavirin-002
NCT01056523
January 2010
Name | Location |
---|