Phase 3
N=1,106
Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
Chronic Myelogenous Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00333840 ↗Enrolled (actual)
1,106
Serious AEs
37.7%
Results posted
Oct 2013
Primary outcome: Primary: Kaplan-Meier Estimates of Overall Survival (All Randomized Participants) — 98.9; 97.7; 96.0; 93.6 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- imatinib mesilate (Drug); interferon-alpha (INF-a) (Drug); cytarabine (ARA-C) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kaplan-Meier Estimates of Overall Survival (All Randomized Participants) |
98.9; 97.7; 96.0; 93.6; 92.4; 89.8 | — |
| SECONDARY Kaplan Meier Estimates of Event Free Survival (All Randomized Participants) |
96.6; 79.4; 89.6; 70.0; 85.3; 67.0 | — |
| SECONDARY Percentage of Participants With Event Free Survival Events (All Randomized Participants) |
17.9; 32.2; 6.9; 12.8; 2.7; 7.6 | — |
| SECONDARY Kaplan Meier Estimates of Time to Progression to Accelerated Phase (AP) or Blast Crisis (BC) (All Randomized Participants) |
98.5; 92.9; 95.7; 90.0; 94.0; 87.9 | — |
| SECONDARY Percentage of Participants With Best Cytogenetic Response (First-line Treatment) |
89.0; 23.3; 82.8; 11.6; 6.1; 11.8 | — |
| SECONDARY Percentage of Participants With Best Cytogenetic Response (Second-line Treatment) |
14.3; 86.0; 7.1; 81.0; 7.1; 5.0 | — |
| SECONDARY Number of Participants With Serious Adverse Events as a Measure of Safety (First-line Treatment) |
226; 163 | — |
| SECONDARY Number of Participants With Serious Adverse Events as a Measure of Safety (Second-line Treatment) |
2; 160 | — |
| SECONDARY Percentage of Participants With Major Molecular Response (First-line Treatment) |
50.2; 9.6; 69.6; 25.0; 76.5; 28.6 | — |
| SECONDARY Percentage of Participants With Major Molecular Response (Second-line Treatment) |
51.2; 69.4; 78.5; 81.9; 86.2; 91.1 | — |
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.
Eligibility Criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Additional protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00333840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.