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.

UMIN ID: C000000357

Registered date:20/03/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hematological malignancies
• Date of first enrollment: 2004/12/01
• Target sample size: 48
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Alemtuzumab is added to the TBI-based or fludarabine-based regimens at 0.16 – 0.25 mg/kg per day for 6 days (days -8 to -3).

Outcome(s)

• Primary Outcome: Survival on day 60 after transplantation Engraftment within 60 days Incidence of grade III to IV acute GVHD within 60 days
• Secondary Outcome: • 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: (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.

Related Information

• Primary Sponsor: GCP-ISS HE0402 group
• Source(s) of Monetary Support: 2004 Health and Labor Sciences Research Grant (Research on Human Genome, Tissue Engineering and Food Biotechnology) of the Ministry of Health, Labor and Welfare.