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NCT Number: NCT06381817

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

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.

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Key information

Conditions

Acute T Cell Lymphoblastic Leukemia Cord Blood Haploidentical Hematopoietic Stem Cell Transplantation Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location status: Recruiting

Location contact

Yang XU

CONTACT

[email protected]

86+051267781850

Yang Xu

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Haplo-cord HCT

Biological

Haploidentical hematopoietic cell transplantation will be performed with coinfusion of an unrelated cord blood unit

Haplo-HCT

Biological

Hematopoietic cell transplantation will be performed with a haploidentical donor

Primary outcomes

  1. Progression-free survival

    Time frame: 2 years after randomization

    estimated progression-free survival at 2 year

Secondary outcomes

  1. Overall survival

    Time frame: 2 years after randomization

    estimated overall survival at 2 year

  2. Cumulative incidence of relapse

    Time frame: 2 years after randomization

    estimated cumulative incidence of relapse at 2 year

  3. Non-relapse mortality

    Time frame: 2 years after randomization

    estimated non-relapse mortality at 2 year

  4. Adverse events

    Time frame: 2 years after randomization

    Number of participants with adverse events. Frequencies of toxicities based on Common Terminology Criteria for Adverse Events (CTCAE) will be tabulated.

Study contacts

Contact information is provided by the study sponsor or research team.

Yang XU

CONTACT

[email protected]

86+051267781850

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Collaborators

  • Children's Hospital of Soochow University
  • First Affiliated Hospital Xi'an Jiaotong University
  • Fujian Medical University Union Hospital
  • Nanfang Hospital, Southern Medical University
  • Ruijin Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Zhejiang University

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 24, 2024
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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