Reduced Intensity Flu/Mel/TBI Conditioning for HAPLO HCT Patients With Hematologic Malignancies

Summary

This is a single arm, phase II trial of HLA-haploidentical related hematopoietic cells transplant (Haplo-HCT) using reduced intensity conditioning (fludarabine and melphalan and total body irradiation). Peripheral blood is the donor graft source. This study is designed to estimate disease-free survival (DFS) at 18 months post-transplant.

Timeline

Start

2019-12-06

Primary completion

2024-02-11

Completion

2024-02-14

Outcome

Met primary endpoint

registry analysis (superiority test); Conditioning Regimen + Transplant; p = 0.002; PFS at 18 Months 70.8; Log Rank; note: One sided log rank test NCT04191187 ↗

Drugs

Indications