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Recruiting NCT06381817

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

Phase III Interventional Acute T Cell Lymphoblastic Leukemia Haploidentical Hematopoietic Stem Cell Transplantation Cord Blood

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Haplo-cord HCT, Haplo-HCT.
Who it may be relevant to
Registry conditions: Acute T Cell Lymphoblastic Leukemia, Haploidentical Hematopoietic Stem Cell Transplantation, Cord Blood. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Haploidentical Hematopoietic Cell Transplantation Combined With an Unrelated Cord Blood Unit for Acute T Cell Lymphoblastic Leukemia Compared to Haploidentical Hematopoietic Cell Transplantation: a Multicenter, Randomized, Open-label Trial

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.

Interventions

  • Biological Haplo-cord HCT
    Haploidentical hematopoietic cell transplantation will be performed with coinfusion of an unrelated cord blood unit
  • Biological Haplo-HCT
    Hematopoietic cell transplantation will be performed with a haploidentical donor

Primary outcome measures

  • Progression-free survival [Time frame: 2 years after randomization]
Secondary outcome measures (4)
  • Overall survival [Time frame: 2 years after randomization]
  • Cumulative incidence of relapse [Time frame: 2 years after randomization]
  • Non-relapse mortality [Time frame: 2 years after randomization]
  • Adverse events [Time frame: 2 years after randomization]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Soochow University — Suzhou

Identifiers

NCT: NCT06381817 · 2024112

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗