A phase II multicenter study of mycophenolate mofetil for acute graft-versus-host disease (aGVHD) prophylaxis in allogeneic hematopoietic stem cell transplantation from related donors
- Conditions
- Patients with hematological disease scheduled to undergo first hematopoietic stem cell transplantation.
- Registration Number
- JPRN-UMIN000003713
- Lead Sponsor
- Grant for anticancer project from Ministry of Health, Welfare, and Labor of Japan.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 19
Not provided
(1)Major organ dysfunction(non-myeloablative SCT): (a)Ejection fraction: <40% (b)Pulmonary function test: %VC<30%, FEV1.0% <40%, or SaO2 <90% on room air (c)Serum creatinine: >2.0mg/dl (d)Liver function: total bilirubin >2.0mg/dl, AST or ALT >3 x UNL, or patients with chronic active hepatitis or liver cirrhosis (2)Poorly controlled hypertension (3)HIV antibody positivity (4)Uncontrolled active infection (5)Uncontrolled CNS invasion (6)Pregnant, nursing or possibly pregnant woman (7)Patients with severe mental disorder who are likely unable to participate in the study (8)Known hypersensitivity or allergy to any of the drugs in the conditioning regimen of this transplant, or drugs used for GVHD prophylaxis (9)No indication for this study as judged by physician in charge.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of grade II to IV aGVHD before day100 post-transplantation
- Secondary Outcome Measures
Name Time Method