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

Phase 3

Recruiting

• Conditions: Acute T Cell Lymphoblastic Leukemia; Haploidentical Hematopoietic Stem Cell Transplantation; Cord Blood
• Interventions: Biological: Haplo-cord HCT; Biological: Haplo-HCT

• Registration Number: NCT06381817
• Lead Sponsor: The First Affiliated Hospital of Soochow University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-04-01
• Study First Submitted: 2024-04-19
• Study First Submitted QC: 2024-04-19
• Study First Posted: 2024-04-24
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-26
• Primary Completion: 2028-03-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 146

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Haplo-cord HCT	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
Haplo-HCT	Haplo-HCT	Patients enrolled in this arm will receive a typical haploidentical hematopoietic cell transplantation

Primary Outcome Measures

Name	Time	Method
Progression-free survival	2 years after randomization	estimated progression-free survival at 2 year

Secondary Outcome Measures

Name	Time	Method
Adverse events	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.
Cumulative incidence of relapse	2 years after randomization	estimated cumulative incidence of relapse at 2 year
Overall survival	2 years after randomization	estimated overall survival at 2 year
Non-relapse mortality	2 years after randomization	estimated non-relapse mortality at 2 year

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China