Phase 2 study of imatinib-combined chemotherapy for newly diagnosed BCR-ABL-positive acute lymphoblastic leukemia (JALSG Ph+ALL202)
- Conditions
- Acute lymphoblastic leukemia
- Registration Number
- JPRN-C000000065
- Lead Sponsor
- Japan Adult Leukemia Study Group
- Brief Summary
Remission induction therapy resulted in complete remission (CR) in 77 patients (96.2%), resistant disease in one patient, and early death in two patients, as well as polymerase chain reaction negativity of bone marrow in 71.3%. The profile and incidence of severe toxicity were not different from those associated with our historic chemotherapy-alone regimen. Relapse occurred in 20 patients after median CR duration of 5.2 months. Allogeneic hematopoietic stem-cell transplantation (HSCT) was performed for 49 patients, 39 of whom underwent transplantation during their first CR. The 1-year event-free and overall survival (OS) rates were estimated to be 60.0%, and 76.1%, respectively, which were significantly better than those for our historic controls treated with chemotherapy alone (P < .0001 for both). Among the current trial patients, the probability for OS at 1 year was 73.3% for those who underwent allogeneic HSCT, and 84.8% for those who did not.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
(1) Uncontrolled active infection (2) Another severe and/or life-threatening disease (3) Positive for HIV antibody and/or HBs antigen tests (4) Another primary malignancy which is clinically active and/or requires medical interventions (5) Pregnant and/or lactating woman (6) Past history of renal failure
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of complete remission
- Secondary Outcome Measures
Name Time Method The duration of remission, overall survival at one year, toxicity