NCT06381817

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Haplo-cord HCT	Haploidentical hematopoietic cell transplantation will be performed with coinfusion of an unrelated cord blood unit
BIOLOGICAL	Haplo-HCT	Hematopoietic cell transplantation will be performed with a haploidentical donor

Timeline

• Start date: 2024-04-01
• Primary completion: 2028-03-31
• Completion: 2028-03-31
• First posted: 2024-04-24
• Last updated: 2024-04-26

Locations

1 site across 1 country: China