Philadelphia chromosome-positive acute lymphoblastic leukemia
Conditions
Interventions
After the 7-day PSL therapy, during which positivity of BCR-ABL fusion transcript must be proved, 4-week DA is given with 3-week PSL to achieve CHR. Then 4-week DA is given following 4 drugs (VCR,CPM,
Sponsors
JALSG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Acute lymphoblastic leukemia. 2. BCR/ABL positive. 3. aged >= 15 years and < 64 years. 4. Patients must not be previously treated except PSL in the prephase PSL therapy. 5. ECOG performance status of 0, 1, 2 or 3. 6. Patients must have adequate cardiac, hepatic, renal, and pulmonary functions. 7. Voluntary written consent must be given before enrollment.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year event-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactIsamu Sugiura
Toyohashi Municipal Hospital Division of Hematology/Oncology
Outcome results
None listed