JRCT ID: jRCTs051180118
Registered date:13/03/2019
Haplo-MAC in Kakogawa
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Hematological malignancy |
Date of first enrollment | 28/09/2017 |
Target sample size | 25 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | HLA-haploidentical related hematopoietic stem cell transplantation with myeloablative conditioning using fludarabine 125 mg/m2, buslfan 12.8 mg/kg and cyclophosphamide 29 mg/kg, and GVHD prophylaxis using post-transplantion CY (syslophosphamide 50mg/kg/day for 2 days) |
Outcome(s)
Primary Outcome | One-year survival rate following transplantation |
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Secondary Outcome | Graft survival rate, 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 |
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Age maximum | <= 60age 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, <=60 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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Atsuo Okamura |
Address | 439, Honmachi Kakogawa-cho Kakogawa-shi, Hyogo, Japan Hyogo Japan 675-8611 |
Telephone | +81-79-451-5500 |
atsuo-okamura@kakohp.jp | |
Affiliation | Kakogawa Central City Hospital |
Scientific contact | |
Name | Atsuo Okamura |
Address | 439, Honmachi Kakogawa-cho Kakogawa-shi, Hyogo, Japan Hyogo Japan 675-8611 |
Telephone | +81-79-451-5500 |
atsuo-okamura@kakohp.jp | |
Affiliation | Kakogawa Central City Hospital |