A randomized trial of ATG in HLA 1-locus mismatched unrelated bone marrow transplantatio

Phase 3

Recruiting

• Conditions: AML, ALL, ATL, CML, MDS, NHL, HL; D015470, D054198, D015459, D015464, D009190, D008228, D006689; AML, ALL, ATL, CML, MDS, NHL, H

• Registration Number: JPRN-jRCTs031180435
• Lead Sponsor: Kanda Yoshinobu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 130

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 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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified