World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 2 April 2019
Main ID:  JPRN-UMIN000004264
Date of registration: 01/11/2010
Prospective Registration: Yes
Primary sponsor: Kobe University Graduate School of Medicine
Public title: 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)
Scientific title:
Date of first enrolment: 2010/11/01
Target sample size: 10
Recruitment status: Complete: follow-up complete
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005113
Study type:  Interventional
Study design:  Single arm Non-randomized  
Phase:  Not selected
Countries of recruitment
Japan
Contacts
Name: Hironobu Minami   
Address:  7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo Japan
Telephone: 078-382-5820
Email: hminami@med.kobe-u.ac.jp
Affiliation:  Kobe University Graduate School of Medicine Medical Oncology/Hematology, Department of Medicine
Name: Atsuo Okamura   
Address:  7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo Japan
Telephone: 078-382-5820
Email: atsuo@med.kobe-u.ac.jp
Affiliation:  Kobe University Hospital Medical Oncology/Hematology
Key inclusion & exclusion 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: 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


Age minimum: 15years-old
Age maximum: 69years-old
Gender: Male and Female
Health Condition(s) or Problem(s) studied
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
Intervention(s)
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 cord blood transplantation) from day 0 to day 10 (for up to 14 days). Thereafter, patients are changed to p.o. MMF at the same dose and interval. After day 31, the dose tapers depending on individual risk factors for GVHD.
Blood samples (2 ml) for PK analysis are collected in EDTA tubes at 0, 0.5, 1, 2, 4, 8, and 12 h after the morning dose on days 2 and 9 during i.v. MMF administration and at 0, 1, 2, 4, 8, and 12 h on day 16 during p.o. MMF administration.
Total mycophenolic acid (MPA) levels are quantified by reverse-phase HPLC.
After quantification, non-compartmental analyses of total MPA concentration time data are conducted to estimate the AUC.
Primary Outcome(s)
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(s)
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
Secondary ID(s)
Source(s) of Monetary Support
None
Secondary Sponsor(s)
School of Pharmacy and Pharmaceutical Science, Mukogawa Women's University
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history