Actively Recruiting

Phase 3
All Genders
NCT06381817

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

Led by The First Affiliated Hospital of Soochow University · Updated on 2024-04-26

146

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

Sponsors

T

The First Affiliated Hospital of Soochow University

Lead Sponsor

C

Children's Hospital of Soochow University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with acute T cell lymphoblastic leukemia
  • 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
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
  • Signed informed consent and ability to comply with study and follow-up procedures
Not Eligible

You will not qualify if you...

  • Presence of other malignancies
  • Failure to acquire a suitable unrelated cord blood unit
  • Previous history of autologous hematopoietic cell transplantation, allogeneic hematopoietic cell transplantation, or chimeric antigen receptor T cell therapy
  • Uncontrolled infection intolerant to haploidentical hematopoietic cell transplantation
  • Severe organ dysfunction
  • Pregnancy or lactation period
  • Any condition deemed unsuitable for the trial by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215000

Actively Recruiting

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Research Team

Y

Yang XU

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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