Evaluation of the safety and efficacy of allogenic hematopoietic stem cell transplantation (HSCT) from HLA-mismatched related donors using alemtuzumab in patients with hematological malignancies.
- Conditions
- Hematological malignancies
- Registration Number
- JPRN-C000000357
- Lead Sponsor
- GCP-ISS HE0402 group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 48
Not provided
(1)Adult T cell leukemia/lymphoma (2)Diabetes uncontrollable even with regular insulin use. (3)Uncontrollable hypertension. (4)Active infection. (5)Refractory hematological malignancies with bone marrow involvement more than 30% of tumor cells. (6)Active central nervous system involvement. (7)Current active double cancer. (8)Women who are or may be pregnant, or who are nursing. (9)Uncontrollable mental illness. (10)Hepatitis B virus antigen-positive (HBsAg or HBeAg). (11)HIV-positive. (12)A history of hypersensitivity to transplant conditioning agents (fludarabine phosphate, busulfan, cyclophosphamide) or agents for GVHD prophylaxis (ciclosporin, methotrexate). (13)A history of hematopoietic stem cell transplantation. However, a single prior autologous transplantation is permitted.
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 III to IV acute GVHD within 60 days
- Secondary Outcome Measures
Name Time Method •Progression-free survival at day 365 •Progression-free mortality at day 365 •Regimen-related toxicity •Incidence of infectious disease •Overall survival at day 365 •Anti-tumor effects