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

Phase 2
18 Years
Not Enrolling
Acute Myelocytic Leukemia

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Trial Information

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

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.

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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Measure: Overall response rate

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Sarit Assouline, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jewish General Hospital


Canada: Health Canada

Study ID:




Start Date:

April 2007

Completion Date:

February 2010

Related Keywords:

  • Acute Myelocytic Leukemia
  • AML
  • Acute myelocytic leukemia
  • leukemia
  • relapsed
  • refractory
  • M4
  • M5
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid