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

April 24, 2024 updated by: The First Affiliated Hospital of Soochow University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

146

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:
        • Principal Investigator:
          • Yang Xu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Haplo-cord HCT
Patients enrolled in this arm will receive a coinfusion of cord blood unit in addition to a typical haploidentical hematopoietic cell transplantation
Biological: Haplo-cord HCT
Haploidentical hematopoietic cell transplantation will be performed with coinfusion of an unrelated cord blood unit
Active Comparator: Haplo-HCT
Patients enrolled in this arm will receive a typical haploidentical hematopoietic cell transplantation
Biological: Haplo-HCT
Hematopoietic cell transplantation will be performed with a haploidentical donor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 2 years after randomization
estimated progression-free survival at 2 year
2 years after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 2 years after randomization
estimated overall survival at 2 year
2 years after randomization
Cumulative incidence of relapse
Time Frame: 2 years after randomization
estimated cumulative incidence of relapse at 2 year
2 years after randomization
Non-relapse mortality
Time Frame: 2 years after randomization
estimated non-relapse mortality at 2 year
2 years after randomization
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.
2 years after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Collaborators

First Affiliated Hospital Xi'an Jiaotong University
Ruijin Hospital
Wuhan Union Hospital, China
Fujian Medical University Union Hospital
Zhejiang University
Children's Hospital of Soochow University
Nanfang Hospital, Southern Medical University

Investigators

  • Principal Investigator: Yang XU, The First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

April 19, 2024

First Submitted That Met QC Criteria

April 19, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024112

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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