Evaluation of the safety and efficacy of allogeneic hematopoietic stem cell transplantation (HSCT) using alemtuzumab for patients with aplastic anemia
Phase 1
- Conditions
- Aplastic anemia
- Registration Number
- JPRN-C000000356
- Lead Sponsor
- GCP-ISS HE0403 group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 38
Inclusion Criteria
Not provided
Exclusion Criteria
(1)Diabetes uncontrollable even with regular insulin use. (2)Uncontrollable hypertension. (3)Current active infection. (4)5% or more malignant cell involvement in bone marrow. (5)Abnormality in chromosome 7 detected by bone marrow G-banding or FISH. (6)Current active cancer. (7)Pregnant or nursing women or women who may be pregnant. (8)Uncontrollable mental illness. (9)Hepatitis B virus antigen-positive (HBsAg or HBeAg). (10)HIV-positive. (11)A history of hypersensitivity to transplant conditioning agents (fludarabine phosphate, cyclophosphamide) or agents for GVHD prophylaxis (ciclosporin, methotrexate). (12)A history of hematopoietic stem cell transplantation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival on day 60 after transplantation Engraftment within 60 days Incidence of grade II to IV acute GVHD within 60 days
- Secondary Outcome Measures
Name Time Method •Regimen-related toxicity •Incidence of infectious disease •Overall survival at day 365 •Therapeutic efficacy for aplastic anemia