Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00333840 | Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia | PHASE3 | COMPLETED | 1,106 | — | — | Jun 1, 2000 | Mar 1, 2012 | Oct 14, 2013 | 163 | United States, Australia +14 |
Overall survival was defined as the time between date of randomization and death due to any cause. The time was censored at last examination date for patients who were still being treated and at date of last contact for patients who discontinued treatment. Kaplan-Meier estimates of the percentage of participants at each time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment.
| Arm | Type | Description |
|---|---|---|
| imatinib (STI571) | EXPERIMENTAL | In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10\^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m\^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m\^2/day (max 40 mg) SC injection for 10 days every month. Maximum study duration was 11.5 years. |
| IFN-a+Ara-C | ACTIVE_COMPARATOR | In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m\^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m\^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10\^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years. |
| Name | Type | Description |
|---|---|---|
| imatinib mesilate | DRUG | imatinib supplied as 100 mg and 400 mg tablets or 100 mg capsules. |
| interferon-alpha (INF-a) | DRUG | interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m\^2/day. |
| cytarabine (ARA-C) | DRUG | cytarabine 20 mg/m\^2/day (max 40 mg) SC for 10 days every month. |
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 ...