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

Haploidentical Hematopoietic Stem Cell Transplantation Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06381817
• Other study ID #: 2024112
• Status: Recruiting
• Phase: Phase 3
• Start date: April 1, 2024
• Est. completion date: March 31, 2028

Study information

• Verified date: April 2024
• Source: The First Affiliated Hospital of Soochow University
• Contact: Yang XU
• Phone: 86+051267781850
• Email: xuyang1020[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: March 31, 2028
• Est. primary completion date: March 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Cord Blood
• Haploidentical Hematopoietic Stem Cell Transplantation
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Biological:
• Haplo-cord HCT
Haploidentical hematopoietic cell transplantation will be performed with coinfusion of an unrelated cord blood unit
• Haplo-HCT
Hematopoietic cell transplantation will be performed with a haploidentical donor

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (8)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University	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, Wuhan Union Hospital, China, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	estimated progression-free survival at 2 year	2 years after randomization
Secondary	Overall survival	estimated overall survival at 2 year	2 years after randomization
Secondary	Cumulative incidence of relapse	estimated cumulative incidence of relapse at 2 year	2 years after randomization
Secondary	Non-relapse mortality	estimated non-relapse mortality at 2 year	2 years after randomization
Secondary	Adverse events	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