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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028008
Receipt No. R000030840
Scientific Title A randomized trial comparing conventional GVHD prophylaxis vs. anti-thymocyte globulin-combined GVHD prophylaxis in HLA 1-locus mismatched unrelated bone marrow transplantation.
Date of disclosure of the study information 2017/07/01
Last modified on 2017/07/11

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Basic information
Public title A randomized trial comparing conventional GVHD prophylaxis vs. anti-thymocyte globulin-combined GVHD prophylaxis in HLA 1-locus mismatched unrelated bone marrow transplantation.
Acronym A randomized trial comparing ATG vs. no ATG in HLA 1-locus mismatched transplantation.
Scientific Title A randomized trial comparing conventional GVHD prophylaxis vs. anti-thymocyte globulin-combined GVHD prophylaxis in HLA 1-locus mismatched unrelated bone marrow transplantation.
Scientific Title:Acronym A randomized trial comparing ATG vs. no ATG in HLA 1-locus mismatched transplantation.
Region
Japan

Condition
Condition Acute myeloid leukemia
Acute lymphoblastic leukemia
Adult T cell leukemia
Chronic myelogenous leukemia
Myelodysplastic syndrome
Non-Hodgkin lymphoma
Hodgkin lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the treatment success rate of conventional GVHD prophylaxis of tacrolimus /methotrexate with anti-thymocyte globulin-combined GVHD prophylaxis in hematopoietic stem cell transplantation from an unrelated donor with HLA-1 locus mismatch
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Success rate at 1 year after transplantation
(Success is defined as the situation without the following events within 1 year after transplantation
1. Death
2. Relapse
3. Grades III-IV acute GVHD
4. Severe chronic GVHD or mild chronic GVHD requiring systemic steroid treatment)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Conventional GVHD prophylaxis (non ATG group)
Tacrolimus is started on day -1 at a dose of 0.02 - 0.03 mg/kg per day by continuous infusion, and the dose is adjusted to maintain a blood concentration between 12 and 15 ng/mL. Methotrexate is administered at 10 mg/m2 on day 1 and 7 mg/m2 on days 3, 6, 11.


Interventions/Control_2 ATG group
Tacrolimus is started on day -1 at a dose of 0.02 - 0.03 mg/kg per day by continuous infusion, and the dose is adjusted to maintain a blood concentration between 12 and 15 ng/mL. Methotrexate is administered at 10 mg/m2 on day 1 and 7 mg/m2 on days 3, 6, 11.
Thymoglobulin is administered at 1.25 mg/kg per day on day-4 and day-3.
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
65 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients who have one of the following disease statuses
(a) AML: any stages with <=50% of blasts in BM and PB
(b) ALL: any stages with <=50% of blasts in BM and PB
(c) ATL: any stages with <=50% of malignant cells in BM and PB
(d) CML: stages with either >=CP2, AP, BP, or failure to 2 types of TKIs, with <=50% of blasts in BM and PB
(e) MDS: IPSS, intermediate-II or high; WPSS, intermediate-II or high; relapse after remission
(f) NHL: patients who have one of the following statuses
(1)low-grade lymphoma: chemo-refractory, relapse after autologous SCT, CR or PR after >=3 lines of chemotherapy
(2) intermediate-grade lymphoma: PR,>=CR2
(3) high-grade lymphoma: PR, CR
(g) Hodgkin lymphoma: PR, >=CR2
2. Patients who are 16 to 65 years old
3. Patients who do not have an available HLA-A, -B, -DR matched related donor
4. Patients who do not have an HLA-A, -B, -C, -DRB1 8/8 allele matched unrelated donor candidate, or it takes long time for donor coordination because of lack of allele information, etc, despite many HLA-A, -B, -DR antigen matched donor candidates.
5. Patients who have an unrelated bone marrow donor with an HLA-1 locus mismatch at HLA-A, -B, -C, and -DRB1 locus.
6. Donors who are 20 to 55 years old
7. Patients with ECOG performance status of 0, 1, or 2
8. Patients whose major organ functions (heart, lung, liver, kidney) are preserved and who meet all of the following criteria
(a) Ejection fraction>=40%
(b) SaO2>=94% on room air or SpO2>=94% on room air
(c) Pulmonary function test: %VC>=70%, FEV1.0%>=70%
(d) Serum total bilirubin <=2.0 mg/dl and serum AST<=5 x UNL
(e) Ccr >=30ml/min
Key exclusion criteria 1. Presence of donor-specific HLA antibodies
2. Patients with HBs antibody positive
3. Patients with HIV antibody positive
4. Patients with serious mental disorder who are likely unable to participate in the study
5. Patients who are pregnant, nursing, or possibly pregnant
6. Patients with coexistence of malignancy
7. Patients with poorly controlled active infection
8. Patients who are allergic to ATG
9. Prior history of allogeneic hematopoietic cell transplantation within 1 year
Target sample size 130

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinobu Kanda
Organization Jichi Medical University Hospital
Division name Department of Hematology
Zip code
Address Yakusiji 3311-1, Simotsuke city, Tochigi, Japan
TEL 0285-58-7353
Email ycanda-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junya Kanda
Organization Kyoto University Hospital
Division name Department of Hematology and Oncology
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL 075-751-3152
Homepage URL
Email jkanda16@kuhp.kyoto-u.ac.jp

Sponsor
Institute Clinical research committee of the Japan Society for Hematopoietic Cell Transplantation
Institute
Department

Funding Source
Organization Clinical research committee of the Japan Society for Hematopoietic Cell Transplantation
Organization
Division
Category of Funding Organization Other
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
2017 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Open public recruiting
Date of protocol fixation
2017 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 10 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
2017 Year 06 Month 30 Day
Last modified on
2017 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030840

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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