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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Contact Information
Primary
Yang XU
xuyang1020@126.com
86+051267781850
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 146
Treatments
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
Active_comparator: Haplo-HCT
Patients enrolled in this arm will receive a typical haploidentical hematopoietic cell transplantation
Sponsors
Leads: The First Affiliated Hospital of Soochow University
Collaborators: Nanfang Hospital, Southern Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Ruijin Hospital, Zhejiang University, First Affiliated Hospital Xi'an Jiaotong University, Fujian Medical University Union Hospital, Children's Hospital of Soochow University

This content was sourced from clinicaltrials.gov

Similar Clinical Trials