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

Phase 3RecruitingNCT06381817

The First Affiliated Hospital of Soochow University146 enrolled

Overview

The goal of this clinical trial is to learn if haploidentical hematopoietic cell transplantation combined with an unrelated cord blood unit (haplo-cord HCT) works to treat acute T cell lymphoblastic leukemia (T-ALL). It will also learn about the safety of the transplantation. The main questions it aims to answer are: Dose co-infusion of cord blood in haploidentical hematopoietic cell transplantation (haplo-HCT) lower the rate of relapse? What medical problems do participants have when having haplo-cord HCT? Researchers will compare haplo-cord HCT to haplo-HCT to see if haplo-cord HCT works to treat T-ALL. Participants will be infused an unrelated cord blood unit at the same day of haploidentical graft infusion.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

146

Conditions

Acute T Cell Lymphoblastic Leukemia Haploidentical Hematopoietic Stem Cell Transplantation Cord Blood

Interventions

Haplo-cord HCTBIOLOGICAL

Haploidentical hematopoietic cell transplantation will be performed with coinfusion of an unrelated cord blood unit

Haplo-HCTBIOLOGICAL

Hematopoietic cell transplantation will be performed with a haploidentical donor

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with acute T cell lymphoblastic leukemia * With available minimal residual disease parameters assessed by flow cytometry and/or quantitative polymerase chain reaction * Willing to undergo haploidentical hematopoietic cell transplantation and having a suitable haploidentical donor * With Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 * Signing an informed consent form, having the ability to comply with study and follow-up procedures Exclusion Criteria: * With other malignancies * Failing to acquire a suitable unrelated cord blood unit * With a previous history of autologous hematopoietic cell transplantation, allogeneic hematopoietic cell transplantation or chimeric antigen receptor T cell therapy * With uncontrolled infection intolerant to haploidentical hematopoietic cell transplantation * With severe organ dysfunction * In pregnancy or lactation period * With any conditions not suitable for the trial (investigators' decision)