UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004264 |
|---|---|
| Receipt number | R000005113 |
| Scientific 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) |
| Date of disclosure of the study information | 2010/11/01 |
| Last modified on | 2018/10/01 15:29:02 |
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Basic information
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)
Acronym
A PK/Phase I study of i.v. MMF for GVHD prophylaxis
Scientific 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:Acronym
A PK/Phase I study of i.v. MMF for GVHD prophylaxis
Region
| Japan |
Condition
Condition
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
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This PK/Phase I study is conducted to establish i.v. MMF dosing for GVHD prophyraxis as a substitute for p.o. MMF at the inability to oral intake after allo-SCT.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Age between 15 and 69 years
2. ECOG performance status 0 or 1
3. Written informed consent for participation
Key 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
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironobu Minami |
Organization
Kobe University Graduate School of Medicine
Division name
Medical Oncology/Hematology, Department of Medicine
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5820
hminami@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuo Okamura |
Organization
Kobe University Hospital
Division name
Medical Oncology/Hematology
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5820
Homepage URL
atsuo@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
School of Pharmacy and Pharmaceutical Science, Mukogawa Women's University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
神戸大学医学部附属病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/295117
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 24 | Day |
Last modified on
| 2018 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005113
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