HLA2-3 antigen mismatched stem cell transplantation from related donor

UMIN ID: C000000403

Registered date:12/04/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Refractory hematologic malignancies (acute myeloid leukemia, chronic myeloid leukemia, myelodysplastic syndrome, malignant lymphoma, multiple myeloma, severe aplastic anemia)
• Date of first enrollment: 2006/04/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): HLA 2-3 antigen mismatched stem cell transplantation from related donor

Outcome(s)

• Primary Outcome: Rate of donor cell engraftment (>90% of donor origin) and incidence of severe GVHD (Phase I) Disease free survival at 1 year after transplantation (Phase II)
• Secondary Outcome: Incidence and severity of chronic GVHD Treatment related mortality within 1 year after transplantation Incidence of infections (bacteria, fungus, virus, etc) Immune reconstitution after transplantation GVL effect Late onset transplantation related complications

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: 45years-old
• Gender: Male and Female
• Exclude criteria: 1) Allergy for the agents used in conditioning or GVHD prophylaxis 2) Patients who are considered as inappropriate with other reasons

Related Information

• Primary Sponsor: Hyogo College of Medicine
• Source(s) of Monetary Support: none