At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 29 enrolled
Drug / intervention
Ribavirin +1 moredrug
Likely dose
Ribavirin 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Study of Ribavirin and Low-dose Cytarabine Arabinoside (Ara-C) in Acute Myeloid Leukemia (AML) M4 and M5 Subtypes, and AML With High eIF4E Expression
In Brief
A Phase 2 clinical trial evaluating Ribavirin and Cytarabine arabinoside for Acute Myeloid Leukemia. Completed, enrolled 29 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia
CountriesCanada
CollaboratorsThe Leukemia and Lymphoma Society
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2010
First PostedJan 2010
Primary CompletionJan 2015
TodayJul 2026
First PostedJan 26, 2010
Enrollment StartJan 1, 2010
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 16.4 years ago
Interventions
Ribavirindrug
Dose level 1 = 1000 mg po BID/ Dose level 2 = 1400 mg po BID/ Dose level 3 = 1800 mg po BID
Cytarabine arabinosidedrug
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.