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)

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) - A PK/Phase I study of i.v. MMF for GVHD prophylaxis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004264

Enrollment

Registered

2010-11-01

Start date

2010-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

For GVHD prophylaxis, MMF is administered 4-6 h after allo-SCT at a dose of 1000 mg i.v. (diluted to a concentration of 6 mg/ml using 5% Dextrose, over 2 h) thrice daily (or twice daily in the case of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age between 15 and 69 years 2. ECOG performance status 0 or 1 3. Written informed consent for participation

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactAtsuo Okamura

Kobe University Hospital Medical Oncology/Hematology

atsuo@med.kobe-u.ac.jp078-382-5820

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026