Phase II study of dasatinib (DA) in combination with chemotherapy and allogeneic stem cell transplantation (SCT) for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia by Japan Acute Leukemia Study Group (JALSG Ph+ALL213)
- Conditions
- Philadelphia chromosome-positive acute lymphoblastic leukemia
- Registration Number
- JPRN-UMIN000012173
- Lead Sponsor
- JALSG
- Brief Summary
DA-based two-step induction in which DA was introduced instead of IM to enhance efficacy and two-step induction to minimize toxicity showed improved survival significantly in terms of the primary endpoint of 3Y-EFS. Toxicity was minimized. No one died of chemotherapy-related toxicity. However, 16% of patients died of transplanted-related toxicity. 3Y-EFS and OS for the evaluable patients were 66% and 82%, Those of patients who underwent alloHSCT in CR1 were 72% and 88%, respectively
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 81
Not provided
1. Heart insufficiency. 2. Pulmonary fibrosis, interstitial pneumonitis. 3. Uncontrollable diabetes mellitus. 4. Grade 4 infection. 5. HIV antibody positive. 6. HBs antigen positive. 7. Concurrent disease which may exaggerate adverse events by dasatinib. 1) Pleural effusion, ascites, or other fluid retention.. 2) Congenital bleeding diathesis. 3) Diseases requiring anticoagulant or anti-platelet agents. 4) Acquired bleeding diathesis.. 8. Psychiatric illness. 9. Active another malignancy. 10. Female patients who are breast feeding or pregnant. 11. Patients who, in the judgment of the investigator, would be inappropriate for entry into this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3-year event-free survival
- Secondary Outcome Measures
Name Time Method Key secondary endpoints are; 1. The proportion of complete hematological remission (CHR) after induction. 2. The proportion of complete molecular remission (CMR) at the following points. (1) after intensive consolidation (2) pre- and day30, day100 post- SCT. 3. 3-, and 5-year OS, EFS, RFS. 4. Prognostic significance of CMR at the following points. (1) after intensive consolidation, (2) pre-SCT, (3) day30 of post-SCT, (4) day100 of post-SCT 5. The efficacy of hematopoietic SCT; day100, 1-year OS, RFS, relapse rate, non-relapse mortality. 6. Prognostic significance of additional cytogenetic abnormalities 7. The proportion of therapy related mortality 8. Analysis of early death in induction and intensive consolidation therapy. 9. The frequency of adverse events in each steps of treatment. 10. Safety of hematopoietic SCT; frequency of graft failure, acute and chronic GVHD.