Single-arm confirmatory trial for the strategy including allogeneic hematopoietic stem cell transplantation for adult T-cell leukemia-lymphoma(JCOG0907, ATL-alloHSCT)

Phase 3

• Conditions: adult T-cell leukemia-lymphoma

• Registration Number: JPRN-UMIN000004147
• Lead Sponsor: Japan Clinical Oncology Group (JCOG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-02
• Study Completion: 2022-03-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Not provided

Exclusion Criteria

1) History of glaucome 2) Uncontrollable diabetes mellitus or administration of insulin 3) Uncontrollable hypertension 4) Poor cardiac function 5) Active infection requiring systemic therapy 6) Fever over 38 degrees centigrade 7) HBs antigen positive 8) HCV antibody positive 9) HIV antibody positive 10) Acute hepatitis or liver cirrhosis 11) Interistitial pneumonitis, pulmonary fibrosis or pulmonary emphysema 12) Synchronous or metachronous malignancy 13) History of malignant lymphoma or leukemia 14) Women during pregnancy or milk breast-feeding 15) Psychological problem 16) Radiation for bulky mass 17) Systemic steroid treatment 18) History of interferon-alpha administration 19) History of allergic reaction by antibody drugs except for gamma globulin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of 3-year survival

Secondary Outcome Measures

Name	Time	Method
Overall survival, 3-year survival of subgroups, adverse events, treatment related mortality