JPRN-C000000356
Completed
Phase 1
Evaluation of the safety and efficacy of allogeneic hematopoietic stem cell transplantation (HSCT) using alemtuzumab for patients with aplastic anemia - HSCT for aplastic anemia using alemtuzumab
GCP-ISS HE0403 group0 sites38 target enrollmentMarch 20, 2006
ConditionsAplastic anemia
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Aplastic anemia
- Sponsor
- GCP-ISS HE0403 group
- Enrollment
- 38
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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