At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years with histologically confirmed Ph+ leukemia: accelerated phase CML, relapsed/refractory ALL or AML, or lymphoid blastic phase CML
- ✓Serum AST/ALT ≤3x ULN (or ≤5x ULN if suspected leukemic liver involvement)
- ✓Serum creatinine ≤2x ULN
- ✓Total serum bilirubin ≤3x ULN
- ✕ECOG performance status ≥3
- ✕Known leukemic involvement of the central nervous system (CNS)
- ✕Recent treatment with interferon-alpha (within 48 hours), hydroxyurea (within 24 hours), homoharringtonine (within 14 days), cytosine arabinoside (within 7-28 days depending on dose), vinca alkaloids, 6-mercaptopurine, or steroids (within 7 days)
- ✕Recent treatment with anthracyclines, mitoxantrone, etoposide, methotrexate, or cyclophosphamide (within 21 days) or busulfan (within 6 weeks)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Extension to a Phase II Study to Determine the Safety and Anti-Leukemic Effects of STI571 in Adult Patients With Philadelphia Chromosome Positive Leukemia Including Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, and Accelerated Phase Chronic Myeloid Leukemia
In Brief
A Phase 2 clinical trial evaluating STI571 400 mg and STI571 600 mg for Philadelphia Positive Chronic Myeloid Leukemia and 2 related conditions. Completed, enrolled 293 participants across 12 sites in 5 countries.
Detailed Summary
The objectives of Part 1 of the study were: * To determine the rate of hematologic response (HR) lasting ≥4 weeks in participants with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the accelerated phase (AP). * To evaluate duration of HR, overall survival, cytogenetic response (CyR), time to blast crisis in CML participants in the AP, improvement of symptomatic parameters, tolerability and safety of STI571 treatment. The objective of the extension (Part 2) was: -To enable participants to have access to study drug and continue study treatment and to decrease data collection to include only overall survival and serious adverse events.
Study Details
Timeline
Interventions
STI571 capsules and tablets
STI571 capsules and tablets