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Use of Ribavirin and Low Dose Ara-C to Treat Acute Myeloid Leukemia

NCT01056523 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2023-10-02

Study results available
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Summary

The purpose of the study is to determine the maximum tolerated dose of ribavirin, when given in combination with low-dose ara-C and to determine if it is safe and well-tolerated in patients with acute myeloid leukemia.

Conditions

Interventions

DRUG

Ribavirin

Dose level 1 = 1000 mg po BID/ Dose level 2 = 1400 mg po BID/ Dose level 3 = 1800 mg po BID

DRUG

Cytarabine arabinoside

Previous cohorts at 20 mg bid days 1 to 10 of every 28 day cycle. Dosage modified to 10 mg bid days 1 to 10 of every 28 day cycle for more recent cohorts.

Sponsors & Collaborators

  • The Leukemia and Lymphoma Society

    collaborator OTHER

  • Jewish General Hospital

    lead OTHER

Principal Investigators

  • Sarit Assouline, MD · Jewish General Hospital, McGill University

  • Katherine Borden, PhD · Université de Montréal

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01056523 on ClinicalTrials.gov