HLA-mismatched HSCT for high-risk hematological disease with adjusted immunosuppressabts and low-dose alemtuzumab

Phase 1

• Conditions: Patients with high-risk advanced hematological disease; High-risk advanced hematological disease; D006402

• Registration Number: JPRN-jRCTs031180237
• Lead Sponsor: Kanda Yoshinobu

Brief Summary

The rate of the achievement of primary outcome measure was more than 80%, but the RR at 1 year was high. Most patients had uncontrollable, non-remission disease, and in addition, many patients had a history of previous allogeneic transplantation. These affected outcomes a lot, but we need to decrease a relapse rate by inducing new methods, such as the further reduction of immunosuppressants after transplantation and donor lymphocyte infusion (DLI) at the early phase after transplantation.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-12
• Study Completion: 2020-02-10
• Results First Posted: 2021-01-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

1.Patients who do not have an available HLA-matched or one locus-mismatched related donor.
2.Patients who have a two- or three-locus-mismatched haploidentical related donor in good condition. (This donor should precede an HLA-matched or one locus-mismatched related donor according to the disease status.)
3.Patients who do not have an HLA-matched or one allele-mismatched unrelated donor, or patients whose disease status preclude time-consuming donor coordination.
4.Patients with high-risk advanced hematological disease. Leukemia and malignant lymphoma in non-remission, MDS with more than 20% of blast, and relapsed disease after allogeneic transplantation are included in high-risk group.
5.Patients who are 16 to 70 years old
6.Patients in performance status of 0 or 1.
7.Patients whose major organ functions are preserved.

Exclusion Criteria

1.Patients with poorly controlled active infection.
2.Patients with coexistence of malignancy.
3.Patients who are pregnant or nursing.
4.Patients with serious mental disorder.
5.Patients with HIV antibody positive.
6.Patients who are allergic to drugs used in conditioning regimen or GVHD prophylaxis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified