Haploidentical Hematopoietic Cell Transplantation Combined With an Unrelated Cord Blood Unit Compared to Haploidentical Hematopoietic Cell Transplantation for Acute T Cell Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating haploidentical hematopoietic cell transplantation combined with an unrelated cord blood unit (haplo-cord HCT) to treat acute T cell lymphoblastic leukemia (T-ALL). This phase 3 trial aims to determine if co-infusing cord blood lowers relapse rates compared to standard haploidentical transplantation alone and to assess the safety of this approach. The study is sponsored by The First Affiliated Hospital of Soochow University and uses a randomized, open-label design. Participants are assigned to one of two groups: one receives the haplo-cord HCT, which includes both haploidentical graft infusion and an unrelated cord blood unit on the same day, while the other group receives the typical haploidentical hematopoietic cell transplantation without cord blood. The trial compares these two treatments to see which better controls T-ALL. During the study, participants will be monitored for outcomes including progression-free survival, overall survival, relapse rates, non-relapse mortality, and adverse events for up to two years after randomization. Researchers will collect medical data and track participants’ health status to evaluate the effectiveness and safety of the treatments. Total participation time depends on follow-up schedules extending over two years.

Haplo-cord HCT vs. Haplo-HCT for T-ALL Patients