Phase II study of multi-agent chemotherapy in patients with adult precursor T acute lymphoblastic leukemia.

Phase 2

• Conditions: precursor T acute lymphoblastic leukemia

• Registration Number: JPRN-UMIN000010642
• Lead Sponsor: Japan Adult Leukemia Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-15
• Study Completion: 2020-06-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3 year event free survival (EFS)

Secondary Outcome Measures

Name	Time	Method
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