Clinical trial for HLA-haploidentical transplantation using alpha-beta T cell and B cell depletio
- Conditions
- Fanconi anenia severe combined immunodeficiency
- Registration Number
- JPRN-jRCTs032230287
- Lead Sponsor
- Iguchi Akihiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 3
1)Patients with Fanconi anemia or severe combined immunodeficiency who are difficult to receive allogeneic hematopoietic stem cell transplantation (HSCT) using PTCY.
2)At time of registration, patients who require allogeneic HSCT, but HLA7/8 antigen (A, B, C, DRB1) matched or 8/8 antigen matched donor is not available. Therefore, the intended donor is one of the following.
a. HLA4/8 antigen (A, B, C, DRB1) matched related donor.
b. HLA5/8 antigen (A, B, C, DRB1) matched related donor.
c. HLA6/8 antigen (A, B, C, DRB1) matched related donor.
3)Patients under 18 years of age at the time of HSCT.
4)Patients with an ECOG performance status (PS) score of 0-2 at enrollment.
5)Patients with adequate organ function who meet the following criteria at the time of enrollment. Laboratory findings must be within 30 days prior to enrollment.
a.Serum direct bilirubin <1.5mg/dL
b.Serum creatinine
<5 years old, <0.8mg/dL
5-9 years old, <1.2mg/dL
>10 years old, <1.5mg/dL
c.Ejection fraction>45% and QTc<0.45sec
6)Patients whose written consent from legal representative have been obtained to participate in this study.
1) Patients who had received prior HSCT.
2) The donor is unable to use G-CSF due to allergy or other reasons.
3) Patients who have uncontrollable infection.
4) Patients with severe mental disorder.
5) Patients with pregnant or likely to be pregnant.
6) Patients who are ineligible by physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method