JPRN-jRCTs031180399
Recruiting
Phase 2
Single agent graft-versus-host disease prophylaxis with post-transplant cyclophosphamide for stem cell transplantation: a phase II study - SAP-P2
Sakaguchi Hirotoshi0 sites30 target enrollmentStarted: March 20, 2019Last updated:
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Sakaguchi Hirotoshi
- Enrollment
- 30
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- ot applicable to < 20age old (—)
- Sex
- All
Inclusion Criteria
- •1\) Diagnosed as acute leukemia (acute lymphoblastic leukemia/acute myeloblastic leukemia), or lymphoma
- •2\) First or second remission, and planned to have stem cell transplantation
- •3\) Donor for transplantation is one of the follows;
- •a. HLA 6/6 (A, B, DR) matched related donor
- •b. HLA 5/6 (A, B, DR) matched related donor
- •c. HLA 6/6 (A, B, DR) matched unrelated donor
- •4\) Age at transplantation \<20 years
- •5\) ECOG Performance status: 0\-2
- •6\) Sufficient organ function, as follows;
- •a. T\-Bil \<\= 1\.5 mg/dl
Exclusion Criteria
- •1\. Prior allogeneic stem cell transplantation
- •2\. Effusion with grade 2 or worse at CTCAE ver 4\.0
- •3\. Uncontrolled infection
- •4\. Severe psychological disorders
- •5\. Pregnant or suspected pregnancy
- •6\. Not eligible for this study at the discretion of the investigator.
Investigators
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