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Clinical Trials/JPRN-jRCTs031180435
JPRN-jRCTs031180435RecruitingPhase 3

A randomized trial comparing conventional GVHD prophylaxis vs. anti-thymocyte globulin-combined GVHD prophylaxis in HLA 1-locus mismatched unrelated bone marrow transplantation for patients with hematological malignancies. - A randomized trial of ATG in HLA 1-locus mismatched unrelated bone marrow transplantation

Kanda Yoshinobu0 sites130 target enrollmentStarted: March 27, 2019Last updated:
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Trial Snapshot

Phase
Phase 3
Status
Recruiting
Sponsor
Enrollment
130
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
>= 16age old to <= 70age old (—)
Sex
All

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

Investigators

Sponsor
Kanda Yoshinobu

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