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

NCT ID: NCT06381817

Last Updated: 2024-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2028-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Haplo-cord HCT

Intervention Type BIOLOGICAL

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

Haplo-HCT

Patients enrolled in this arm will receive a typical haploidentical hematopoietic cell transplantation

Group Type ACTIVE_COMPARATOR

Haplo-HCT

Intervention Type BIOLOGICAL

Hematopoietic cell transplantation will be performed with a haploidentical donor

Interventions

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Haplo-cord HCT

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

Intervention Type BIOLOGICAL

Haplo-HCT

Hematopoietic cell transplantation will be performed with a haploidentical donor

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Soochow University

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role collaborator

Fujian Medical University Union Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role collaborator

Zhejiang University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yang XU

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochow University

Locations

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The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yang XU

Role: CONTACT

86+051267781850

Facility Contacts

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Yang XU

Role: primary

86+051267781850

Other Identifiers

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2024112

Identifier Type: -

Identifier Source: org_study_id

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