UMIN-CTR Clinical Trial

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
Email

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
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
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IRB Contact (For public release)
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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
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Results Delayed
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Baseline Characteristics
Participant flow
Adverse events
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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
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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=R000004010

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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