NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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) studiedAML, ALL, ATL, CML, MDS, NHL, HL
Date of first enrollment05/09/2017
Target sample size130
Countries of recruitment
Study typeInterventional
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 OutcomeSuccess 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 Outcome1. 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
GenderBoth
Include criteria1. 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 criteria1. 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

Contact

Public contact
Name Shinichiro Fujiwara
Address 3311-1 Yakushiji,Shimotsuke-shi,Tochigi Tochigi Japan 329-0498
Telephone +81-285-58-7353
E-mail 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
E-mail ycanda-tky@umin.ac.jp
Affiliation Jichi Medical University