The efficacy of cyclospolin A and low dose mycophenolate mofetil to prevent GVHD for reduced-intensity (fludarabine , cyclophosphamide , total body irradiation) cord blood stem cell transplantation

UMIN ID: UMIN000001758

Registered date:06/03/2009

Basic Information

• Health condition(s) or Problem(s) studied: Hematologic malignancies
• Date of first enrollment: 2008/10/01
• Target sample size: 57
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Intravenous injection of fludarabine (30mg/m2/day, for 6 days) and cyclophosphamide (50mg/kg/day,once) Use cyclospolin A and mycophenolate mofetil ( for 30 days) as a GVHD prophylaxis

Outcome(s)

• Primary Outcome: Non relapse mortality on day 100 post transplantaion
• Secondary Outcome: 1)Incidence and severity of acute GVHD 2)Incidence of hepatic veno-occlusive disease and thrombotic microangiopathy 3)Incidence of infectious disease 4)Disease-free survival and overall survival rate at 1 year and 2 years after transplantation 5)Engraftment rate 100 days after transplantation 6)Time to hematopoietic recovery

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Double cancer 2) Sever mental disease 3)Seropositive to HIV 4) History of adverse reaction for the agents included in the protocol in conditioning (fludarabine, cyclophosphamide), in GVHD prophylaxis (Cyclosporine A, mycophenolate mofetil) 5) Pregnant or lactating women 6)Inadequate to entry judged by investigators.

Related Information

• Primary Sponsor: RICBT Study Group
• Source(s) of Monetary Support: None