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

This study has been completed.

Sponsor:

Collaborator:

The Leukemia and Lymphoma Society

Information provided by:

Jewish General Hospital

ClinicalTrials.gov Identifier:

NCT00559091

First received: November 15, 2007

Last updated: May 6, 2011

Last verified: September 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

November 15, 2007

Last Updated Date

May 6, 2011

Start Date ^ICMJE

April 2007

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Measure: Overall response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Measure: Overall response rate [ Time Frame: 6 months ]

Change History

Complete list of historical versions of study NCT00559091 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Measure: Safety and tolerability, correlative studies [ Time Frame: 6 months ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase II Study of Ribavirin in Refractory of Relapsed Acute Myelocytic Leukemia M4 and M5 Subtypes

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.

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Acute Myelocytic Leukemia

Intervention ^ICMJE

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)

Study Arm (s)

Experimental: I

Ribavirin

Intervention: Drug: ribavirin

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

February 2010

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00559091

Other Study ID Numbers ^ICMJE

CR0620KB, REC:06-112

Has Data Monitoring Committee

Responsible Party

Dr. Sarit Assouline / Associate Director, Clinical Research Unit, Jewish General Hospital, McGill University

Study Sponsor ^ICMJE

Jewish General Hospital

Collaborators ^ICMJE

The Leukemia and Lymphoma Society

Investigators ^ICMJE

Principal Investigator:	Sarit Assouline, MD	Jewish General Hospital
Study Director:	Kathy Borden, PhD	Université de Montréal

Information Provided By

Jewish General Hospital

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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