Haplo-RIC in Kakogawa

Phase 2

Recruiting

• Conditions: Hematological malignancy; Lymphoma, leukemia, hematological malignancy; 018 019 020

• Registration Number: JPRN-jRCTs051180119
• Lead Sponsor: Okamura Atsuo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

1. Hematopoietic malignant tumors suitable for hematopoietic stem cell transplantation
2. Disease status; remission phase or non-remission phase
3. Age; >=16 year-old, <=65 year-old
4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 2
5. Adequate organ function:
a. Ejection fraction >=50%
b. T-Bil <= 2.0 mg/dl, AST and ALT <= 3 times of the high end of the normal range
c. CCr >=30ml/min
d. SpO2 >=95% (room air)
6. No HLA-matched related donor
7. No HLA-matched unrelated donor
8. Written informed consent

Exclusion Criteria

1. HIV antibody positivity
2. Active multiple primary cancers
3. Active infection
4. Pregnant, unwilling to practice contraception during the study, or lactating female
5. Hypersensitivity to agents used for conditioning and GVHD prophylaxis
6. Specific HLA antibody against donor HLA
7. Administration of anticancer drugs except the study protocol within 13 days before transplantation
8. Other, determination of the attending physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Engraftment

Secondary Outcome Measures

Name	Time	Method
incidence rate and severity of acute/chronic GVHD, incidence rate of infection, GVHD free/relapse free survival, discontinuance rate of immune-suppressive agents, Fever during day 0 and day7, adverse events