Haplo-RIC in Kakogawa

JRCT ID: jRCTs051180119

Registered date:13/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hematological malignancy
• Date of first enrollment: 18/12/2017
• Target sample size: 23
• Study type: Interventional
• Intervention(s): HLA-haploidentical related hematopoietic stem cell transplantation with non-myeloablative conditioning using fludarabine 150 mg/M2, buslfan 6.4 mg/kg and cyclophosphamide 29 mg/kg, and GVHD prophylaxis using post-transplantion CY (cyslophosphamide 50mg/kg/day for 2 days)

Outcome(s)

• Primary Outcome: Engraftment
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 65age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Okamura Atsuo