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UMIN-CTR Clinical Trial |
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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 | 2020/12/31 |
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 |
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Condition | ||
Condition | Acute myeloid leukemia
Acute lymphoblastic leukemia Adult T cell leukemia Chronic myelogenous leukemia Myelodysplastic syndrome Non-Hodgkin lymphoma Hodgkin lymphoma |
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Classification by specialty |
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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 |
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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. |
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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. |
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Interventions/Control_3 | ||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 130 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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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 |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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Recruitment status | Open public recruiting | ||||||
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Last modified on |
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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 | |
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Research case data | |
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