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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003713
Receipt No. R000004008
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 related donors
Date of disclosure of the study information 2010/06/04
Last modified on 2018/09/21

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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 related donors
Acronym MMF for aGVHD prophylaxis in allo-HSCT from related 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 related donors
Scientific Title:Acronym MMF for aGVHD prophylaxis in allo-HSCT from related 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 cyclosporine and micophenolate mofetile 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 intravenous cyclosporine (3mg/kg/day) from day -1.
Patients receive oral mycophenolate mofetil 1500mg/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 and who have a 6/6 HLA antigen-matched related donor
ATG use as part of conditioning regimen is not permitted.

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
Patients in second or greater relapse 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 19

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
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masaaki Kurihara
Organization Japanese Clinical Research 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
Email

Sponsor
Institute Grant for anticancer project from Ministry of Health, Welfare, and Labor of Japan.
Institute
Department

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
Email

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 09 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004008

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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