UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003714 |
|---|---|
| Receipt number | R000004010 |
| Scientific Title | A phase II multicenter study of mycophenolate mofetil for acute graft-versus-host disease (aGVHD) prophylaxis in allogeneic hematopoietic stem cell transplantation from unrelated donors |
| Date of disclosure of the study information | 2010/06/04 |
| Last modified on | 2018/09/21 23:05:05 |
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Basic information
Public title
A phase II multicenter study of mycophenolate mofetil for acute graft-versus-host disease (aGVHD) prophylaxis in allogeneic hematopoietic stem cell transplantation from unrelated donors
Acronym
MMF for aGVHD prophylaxis in allo HSCT from unrelated donors.
Scientific Title
A phase II multicenter study of mycophenolate mofetil for acute graft-versus-host disease (aGVHD) prophylaxis in allogeneic hematopoietic stem cell transplantation from unrelated donors
Scientific Title:Acronym
MMF for aGVHD prophylaxis in allo HSCT from unrelated donors.
Region
| Japan |
Condition
Condition
Patients with hematological disease scheduled to undergo first hematopoietic stem cell transplantation.
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess incidence of grade II to IV aGVHD during use of tacrolimus and micophenolate mofetil as prophylaxis of GVHD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of grade II to IV aGVHD before day100 post-transplantation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients receive cotinuous intravenous tacrolimus (0.03mg/kg/day) from day -1.
Patients receive oral mycophenolate mofetil 3000mg/day from 6h after completion of hematopoietic stem cell transplantation
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
| 16 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with hematological disease who are scheduled to undergo first stem cell transplantation. ATG use as part of conditioning regimen is not permitted. Patients must have HLA-A, B, DR antigen-matched unrelated donor in the bone marrow donor registry, must undergo HLA-A, B, C, DRB1 allele typing test and meet one of the following criteria.
*8/8 HLA match by allele typing
*Only a single antigen or allele disparity allowed for HLA-C, excepting high-risk HLA mismatch combinations for severe aGVHD(7/8 HLA match by allele typing)
*Only a single allele disparity allowed for HLA-DR, excepting high-risk HLA mismatch combinations for severe aGVHD(7/8 HLA match by allele typing)
Eligible diseases;
(a)AML
1. First CR with high or intermediate risk
2. Second CR or greater
3. Relapse or failure to achieve CR after the first course of induction chemotherapy
(b)ALL
1. First CR
2. Second CR or greater
3. Relapse or failure to achieve CR after the first course of induction chemotherapy
(c)Acute leukemias of ambiguous lineage
1. First CR
2. Second CR or greater
3. Relapse or failure to achieve CR after the first course of induction chemotherapy
(d)MDS
1. Patients with poor prognosis who have IPSS scores of int-2 or high
2. Transfusion dependence requiring RBC transfusion over 2 units per week or platelet transfusion over 10 units per week
(e)CML
1. Second CP or greater
2. AP
3. First CP or tyrosine kinase inhibitor failure
(f)Malignant lymphoma
1. Indolent lymphoma
First relapse or greater /progression, regardless of sensitivity to prior chemotherapy
2. Agressive lymphoma
First relapse which are not sensitive to chemotherapy
Patient in second relapse or greater, or relapse after autologous stem cell transplantation who are not likely to relapse or progress within 3 month after transplantation
*ECOG performance status score:0 or 1.
*Normal function of major organ
*Signed informed consent
*A life expectancy beyond 3 months
Key exclusion criteria
(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.
Target sample size
29
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Fukuda |
Organization
National Cancer Center Hospital
Division name
Department of Stem Cell Transplantation
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaaki Kurihara |
Organization
Japanese Clinical Reserch Support Unit
Division name
Data center
Zip code
Address
Nishiyama Kougyou Ochanomizu Bldg. 3F,1-2-13, Yushima, Bunkyo-ku, Tokyo, 113-0034, JAPAN
TEL
03-5297-6258
Homepage URL
Sponsor or person
Institute
Grant for anticancer project from Ministry of Health, Welfare, and Labor of Japan.
Institute
Department
Personal name
Funding Source
Organization
Grant for anticancer project from Ministry of Health, Welfare, and Labor of Japan.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
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 | 04 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 04 | Day |
Last modified on
| 2018 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004010
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