A Study of Ribavirin to Treat M4 and M5 Acute Myelocytic Leukemia

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if ribavirin (a drug commonly used to treat hepatitis C) also has activity in the treatment of patients with refractory or relapsed acute myeloid leukemia (AML) of the M4 and M5 subtype.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jewish General Hospital
• Collaborator: The Leukemia and Lymphoma Society
• Treatments: Ribavirin

Criteria

Inclusion Criteria:

• A diagnosis of acute myeloid leukemia (AML), either M4 or M5 subtype de novo or resulting from a transformation from MDS or a myeloproliferative disorder.

• Patients with AML who (a) have failed primary therapy -defined as failing two induction chemotherapies, (b) have relapsed or (c) are not suitable for intensive induction chemotherapy will be eligible. OR

• Patients with AML blast crisis from CML if they are not suitable candidates for intensive induction chemotherapy or have failed imatinib mesylate OR

• Patients with secondary AML after MDS if they are not suitable candidates for intensive induction chemotherapy.

• ECOG 0,1,2, or 3

• Life expectancy > 12 weeks.

• Adequate renal and hepatic function

Exclusion Criteria:

• Uncontrolled central nervous system involvement by AML

• Active cardiovascular disease as defined by NYHA class III-IV categorization.

• Intercurrent illness or medical condition precluding safe administration of ribavirin.

• Received any previous therapy within 28 days prior to study entry.Hydrea is permitted but must be stopped 7 days prior to starting study drug.

• Known infection with HIV.