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

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

Recruiting
All
Phase 3

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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.

Eligibility

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)

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

NCT06381817

The First Affiliated Hospital of Soochow University

30 April 2024

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FAQs

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