A Study of Ribavirin to Treat M4 and M5 Acute Myelocytic Leukemia (Borden-001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00559091
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : May 9, 2011
The Leukemia and Lymphoma Society
Information provided by:
Jewish General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Myelocytic Leukemia Drug: ribavirin Phase 2

Detailed Description:

The eukaryotic translation initiation factor eIF4E is dysregulated in many human malignancies, including a subset of myeloid leukemia (M4/M5 AML and blast crisis CML). eIF4E overexpression leads to oncogenic transformation. Ribavirin impedes eIF4E mediated transformation in vitro, in primary human specimens and in animal models.

While ribavirin has been used extensively for the treatment of viral hepatitis C and its safety profile has been well defined, it has never been used in patients with AML. This study will establish the efficacy and safety of ribavirin in M4/M5 AML patients. In addition, this study will also include correlative studies to determine the effect of ribavirin on eIF4E activity and eIF4E related pathways in M4/M5 AML patients.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Ribavirin in Refractory of Relapsed Acute Myelocytic Leukemia M4 and M5 Subtypes
Study Start Date : April 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Arm Intervention/treatment
Experimental: I
Drug: ribavirin
Ribavirin will be administered orally, twice daily, in the morning and evening with food. The dose selected is 400 mg AM and 600 mg PM. Intrapatient dose escalations can also be performed in defined circumstances. The maximal dose administered will be 1000 mg AM and 1000 mg PM.
Other Name: Ribasphere (Three Rivers Pharmaceuticals)

Primary Outcome Measures :
  1. Measure: Overall response rate [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Measure: Safety and tolerability, correlative studies [ Time Frame: 6 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00559091

Canada, Ontario
McMaster Hospital
Hamilton, Ontario, Canada, L8N 3Z5
Canada, Quebec
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
Jewish General Hospital
Montreal, Quebec, Canada, H4T 1E2
Sponsors and Collaborators
Jewish General Hospital
The Leukemia and Lymphoma Society
Principal Investigator: Sarit Assouline, MD Jewish General Hospital
Study Director: Kathy Borden, PhD Université de Montréal

Additional Information:
Responsible Party: Dr. Sarit Assouline / Associate Director, Clinical Research Unit, Jewish General Hospital, McGill University Identifier: NCT00559091     History of Changes
Other Study ID Numbers: CR0620KB
First Posted: November 16, 2007    Key Record Dates
Last Update Posted: May 9, 2011
Last Verified: September 2009

Keywords provided by Jewish General Hospital:
Acute myelocytic leukemia

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents