A Study of Ribavirin to Treat M4 and M5 Acute Myelocytic Leukemia (Borden-001)
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|ClinicalTrials.gov Identifier: NCT00559091|
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : May 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|Acute Myelocytic Leukemia||Drug: ribavirin||Phase 2|
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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)
- Measure: Overall response rate [ Time Frame: 6 months ]
- Measure: Safety and tolerability, correlative studies [ Time Frame: 6 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT00559091
|Hamilton, Ontario, Canada, L8N 3Z5|
|Montreal, Quebec, Canada, H1T 2M4|
|Jewish General Hospital|
|Montreal, Quebec, Canada, H4T 1E2|
|Principal Investigator:||Sarit Assouline, MD||Jewish General Hospital|
|Study Director:||Kathy Borden, PhD||Université de Montréal|