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

NCT06381817 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2024-04-26

No results posted yet for this 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.

Conditions

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

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

Sponsors & Collaborators

  • Children's Hospital of Soochow University

    collaborator OTHER
  • Ruijin Hospital

    collaborator OTHER
  • Nanfang Hospital, Southern Medical University

    collaborator OTHER
  • Fujian Medical University Union Hospital

    collaborator OTHER
  • First Affiliated Hospital Xi'an Jiaotong University

    collaborator OTHER
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    collaborator OTHER
  • Zhejiang University

    collaborator OTHER
  • The First Affiliated Hospital of Soochow University

    lead OTHER

Principal Investigators

  • Yang XU · The First Affiliated Hospital of Soochow University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2028-03-31
Completion
2028-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06381817 on ClinicalTrials.gov