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

Soochow University

Status and phase: Enrolling; Phase 3

Conditions: Haploidentical Hematopoietic Stem Cell Transplantation; Cord Blood; Acute T Cell Lymphoblastic Leukemia

Treatments: Biological: Haplo-HCT; Biological: Haplo-cord HCT

Study type: Interventional

Funder types: Other

Identifiers

NCT06381817

2024112

Details and patient eligibility

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.

Enrollment: 146 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

Haplo-cord HCT

Experimental group

Description:

Patients enrolled in this arm will receive a coinfusion of cord blood unit in addition to a typical haploidentical hematopoietic cell transplantation

Treatment:

Biological: Haplo-cord HCT

Haplo-HCT

Active Comparator group

Description:

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

Treatment:

Biological: Haplo-HCT