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

NCT06381817 · tracked via the Priya Life Science China tracker

Sponsor

The First Affiliated Hospital of Soochow University

Phase

Phase 3

Started

2024-04-01

Last updated

2024-04-26

Condition(s) studied

Acute T Cell Lymphoblastic LeukemiaHaploidentical Hematopoietic Stem Cell TransplantationCord Blood

Investigational drug(s) / intervention(s)

Haplo-cord HCTHaplo-HCT

Haplo-cord HCT: Haploidentical hematopoietic cell transplantation will be performed with coinfusion of an unrelated cord blood unit

Haplo-HCT: Hematopoietic cell transplantation will be performed with a haploidentical donor

Study summary

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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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)

Primary outcome measure(s)

Progression-free survival — 2 years after randomization
estimated progression-free survival at 2 year

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu	Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06381817 on ClinicalTrials.gov ↗ ← All trials in China