JRCT ID: jRCTs031180435
Registered date:27/03/2019
A randomized trial of ATG in HLA 1-locus mismatched unrelated bone marrow transplantation
Basic Information
Recruitment status | Recruiting |
---|---|
Health condition(s) or Problem(s) studied | AML, ALL, ATL, CML, MDS, NHL, HL |
Date of first enrollment | 05/09/2017 |
Target sample size | 130 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Conventional GVHD prophylaxis (non ATG group) Tacrolimus is started on day -1 at a dose of 0.01 - 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. ATG group Tacrolimus is started on day -1 at a dose of 0.01 - 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. |
Outcome(s)
Primary Outcome | 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) |
---|---|
Secondary Outcome | 1. Cumulative incidence of neutrophil engraftment 2. Cumulative incidence of platelet engraftment 3. Cumulative incidence of acute GVHD and severity 4. Cumulative incidence of chronic GVHD and severity 5. Cumulative incidence of relapse 6. Cumulative incidence of non-relapse mortality 7. Probability of disease-free survival 8. Probability of overall survival |
Key inclusion & exclusion criteria
Age minimum | >= 16age old |
---|---|
Age maximum | <= 70age old |
Gender | Both |
Include 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 or high or very high;WPSS, high or very 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 70 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 |
Exclude 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 |
Related Information
Primary Sponsor | Kanda Yoshinobu |
---|---|
Secondary Sponsor | |
Source(s) of Monetary Support | Clinical research committee of the Japanese Society for Transplantation and Cellular Therapy |
Secondary ID(s) | UMIN000028008 |
Contact
Public contact | |
Name | Shinichiro Fujiwara |
Address | 3311-1 Yakushiji,Shimotsuke-shi,Tochigi Tochigi Japan 329-0498 |
Telephone | +81-285-58-7353 |
sfujiwar@jichi.ac.jp | |
Affiliation | Jichi Medical University |
Scientific contact | |
Name | Yoshinobu Kanda |
Address | 3311-1 Yakushiji,Shimotsuke-shi,Tochigi Tochigi Japan 329-0498 |
Telephone | +81-285-58-7353 |
ycanda-tky@umin.ac.jp | |
Affiliation | Jichi Medical University |