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.
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
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
Parallel
Haplo-cord HCT
Biological/VaccineHaploidentical hematopoietic cell transplantation will be performed with coinfusion of an unrelated cord blood unit
Haplo-HCT
Biological/VaccineHematopoietic cell transplantation will be performed with a haploidentical donor
Progression-free survival
estimated progression-free survival at 2 year
Overall survival
estimated overall survival at 2 year
Cumulative incidence of relapse
estimated cumulative incidence of relapse at 2 year
Non-relapse mortality
estimated non-relapse mortality at 2 year
Adverse events
Number of participants with adverse events. Frequencies of toxicities based on Common Terminology Criteria for Adverse Events (CTCAE) will be tabulated.
Click on the lead sponsor to view all of their trials.
The First Affiliated Hospital of Soochow University
Lead sponsor
Children's Hospital of Soochow University
Collaborator
Ruijin Hospital
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
Fujian Medical University Union Hospital
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Zhejiang University
Collaborator
