A Pharmacokinetics (PK)/Phase I study of intravenous (i.v.) administration of mycophenolate mofetil (MMF) for graft-versus-host disease (GVHD) prophylaxis after allogeneic hematopoietic stem cell transplantation (allo-SCT)
- Conditions
- Refractory hematologic disorders, including 1. Acute myelogenous leukemia 2. Acute lymphoblastic leukemia 3. Myelodysplastic syndrome 4. Chronic myelogenous leukemia 5. Malignant lymphoma 6. Aplastic anemia
- Registration Number
- JPRN-UMIN000004264
- Lead Sponsor
- Kobe University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Not provided
1. Contraindication of MMF administration 2. SpO2 of less than 93% without oxygen inhalation 3. Serum creatinin of greater than 2.0mg/dl 4. Liver function with serum total bilirubin of greater than 2.0mg/dl, or AST of greater than 4.0 x ULN 5. Left ventricular ejection fraction of less than 50% 6. Past history of cardiac event, or significant cardiac disease 7. Uncontrolled diabetus mellitus 8. Another active neoplastic disease 9. Uncontrolled active infections 10. Serologically positive for HIV antibody and/or HBs antigen 11. Pregnant, or during breast feeding 12. Uncontrolled psychiatric disease 13. Allergic history to drugs used in the conditioning regimens or GVHD prophylaxis regimens 14. Patients suggested as ineligible by their attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. PK analysis of i.v. MMF, and comparison of PK parameters between i.v. and p.o. MMF 2. Grade of treatment-related toxicity by using i.v. MMF
- Secondary Outcome Measures
Name Time Method 1. Time to hematopoietic recovery 2. The cumulative incidence and severity of acute GVHD until day 100 3. Overall survival and progression-free survival at day 100 and 1-year after allo-SCT 4. Drug interaction studies with MMF