A phase I/II trial of HLA haploidentical peripheral blood stem cell transplantation following reduced-intensity conditioning

UMIN ID: C000000253

Registered date:01/10/2005

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Chronic myeloid leukemia, Acute myeloid leukemia, Acute lymphoid leukemia, Myelodysplastic syndrome, Malignant lymphoma
• Date of first enrollment: 2005/10/01
• Target sample size: 25
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): HLA haploidentical peripheral blood stem cell transplantation following reduced-intensity conditioning

Outcome(s)

• Primary Outcome: Neutrophil engraftment within 35 days after transplantation (Phase I) Overall survival at day 100 after transplantion (Phase II)
• Secondary Outcome: Incidence and severity of acute GVHD Incidence and severity of chonic GVHD Overall survival at 1 year after transplantation Diase free survival at 1 year after transplantation Treatment related mortality at 1 year after transplantation Incidence and severity of infectious disease after transplantation Immune reconstitution after transplantation

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: 1) Allergy for the agents used in conditioning or GVHD prophylaxis 2) Positivity for HBs antigen and/or HIV antibody 3) Active lesions in CNS 4) Active infections 5) Patients who are considered as inappropriate with other reasons

Related Information

• Primary Sponsor: Health and Labour Sciences Research Grants, Research on Human Genome, Tissue Engineering, Ministry of Health, Labour and Welfare
• Source(s) of Monetary Support: none