HLA-mismatched HSCT for standard-risk hematological disease using low-dose alemtuzumab

Phase 2

• Conditions: Patients with standard-risk advanced hematological disease; D006402; Standard-risk advanced hematological disease

• Registration Number: JPRN-jRCTs031180238
• Lead Sponsor: Kanda Yoshinobu

Brief Summary

The primary outcome measure of this study was DFS at 1 year, but it was below 50%, which was DFS at 1 year in the previous study using alemtuzumab. In this study, MDS with complex karyotype was included as a standard risk, and such patients relapsed. Risk stratification should be reconsidered. NRM was in an acceptable range. The improvements to decrease the RR are needed, such as the reduction of methotrexate dose based on the protocol which had used in high-risk patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-12
• Study Completion: 2020-12-08
• Results First Posted: 2021-01-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 12

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.
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 standard-risk advanced hematological disease. High-risk acute leukemia, advanced CML, refractory malignant lymphoma, advanced MDS, acute or lymphoma type ATLL, advanced IPF or refractory severe aplastic anemia are regarded as advanced hematological disease, and in advanced disease, leukemia and malignant lymphoma in remission, MDS, IPF or severe aplastic anemia are included in stndard-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