precursor T acute lymphoblastic leukemia
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Recognized ALL 2. Precursor T-ALL (diagnosed by WHO Classification) 3. Age 25 to 64 4. Performance Status: 0 to 3 5. Adequate hepatic, renal and cardiac function 6. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Previously treated with leukapheresis 2. Congestive heart failure 3. Recent history of myocardial infarction 4. Malignant hypertension 5. Lung fibrosis 6. Interstitial pneumonitis 7. Severe comorbidity (diabetes mellitus, infection or liver cirrhosis) 8. Positive anti-HIV antibody or HBs antigen 9. Thrombosis which need treatment 10. Psychological disorders 11. Other active neoplasms 12. Pregnant and/or lactating woman 13. Judged to be inadequate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 year event free survival (EFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete remission rate Adverse event rate 3 year overall survival (OS), and relapse free survival (RFS) Efficacy and safety of hematopoietic stem cell transplantation such as treatment related mortality, relapse, engraftment, acute graft versus host disease (GVHD), and chronic GVHD Relationship between initial steroid reactivity (Blast rates of bone marrow on Day 15) and prognosis such as OS, EFS and RFS | — |
Countries
Japan
Contacts
JALSG-ALL-213 research secretariat Tokyo Women Medical University, Department of Hematology