UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028008 |
|---|---|
| Receipt number | 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 | 2022/07/07 14:09:37 |
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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;IPSS-R, intermediate, high or very 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 | Yoshinobu |
| Middle name | |
| Last name | Kanda |
Organization
Jichi Medical University Hospital
Division name
Department of Hematology
Zip code
329-0431
Address
Yakusiji 3311-1, Simotsuke city, Tochigi, Japan
TEL
0285-58-7353
ycanda-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Junya |
| Middle name | |
| Last name | Kanda |
Organization
Kyoto University Hospital
Division name
Department of Hematology and Oncology
Zip code
606-8507
Address
54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3152
Homepage URL
jkanda16@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Clinical research committee of the Japan Society for Hematopoietic Cell Transplantation
Institute
Department
Personal name
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
Jichi Medical University Clinical Research Ethics Committee
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan
Tel
0285-58-7550
rinri@jichi.ac.jp
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
| 2017 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
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
| 2022 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030840
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