At a glance
ClinicalIndex Comparison Record- ✓Must have signed consent for Amendment 5
- ✓Must have completed visit 62 of the core IRIS trial or be in follow-up
- ✓Must be on STI571 treatment
- ✓If on IFN treatment, must be willing to cross over to STI571 treatment
- ✕Patients who have discontinued from the study and are in follow-up
- ✕Patients who are on IFN treatment and do not want to cross over to STI571 treatment
- ✕Patients who have not consented to amendment 5
- ✕Patients who did not complete the amendment 5 protocol
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Study of STI571 Versus Interferon-α (IFN-α) Combined With Cytarabine (Ara-C) in Patients With Newly Diagnosed Previously Untreated Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
In Brief
A Phase 3 clinical trial evaluating imatinib mesilate, interferon-alpha (INF-a), and 1 other intervention for Chronic Myelogenous Leukemia. Completed, enrolled 1,106 participants across 163 sites in 16 countries.
Detailed Summary
The purpose of this study is to evaluate and compare the side effects and anti-leukemic benefits of imatinib with those of interferon and Ara-C for patients who have chronic myeloid leukemia (CML) in the chronic phase. Patients in this study will be randomized (1:1) to receive either interferon plus Ara-C or imatinib as initial treatment.
Study Details
Timeline
Interventions
imatinib supplied as 100 mg and 400 mg tablets or 100 mg capsules.
interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m\^2/day.
cytarabine 20 mg/m\^2/day (max 40 mg) SC for 10 days every month.