Acute T Cell Lymphoblastic Leukemia, Cord Blood, Haploidentical Hematopoietic Stem Cell Transplantation
Conditions
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.
Interventions
BIOLOGICALHaplo-cord HCT
Haploidentical hematopoietic cell transplantation will be performed with coinfusion of an unrelated cord blood unit
BIOLOGICALHaplo-HCT
Hematopoietic cell transplantation will be performed with a haploidentical donor
Sponsors
Children's Hospital of Soochow University
Ruijin Hospital
Nanfang Hospital, Southern Medical University
Fujian Medical University Union Hospital
First Affiliated Hospital Xi'an Jiaotong University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Zhejiang University
The First Affiliated Hospital of Soochow University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 2 years after randomization | estimated progression-free survival at 2 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 2 years after randomization | estimated overall survival at 2 year |
| Cumulative incidence of relapse | 2 years after randomization | estimated cumulative incidence of relapse at 2 year |
| Non-relapse mortality | 2 years after randomization | estimated non-relapse mortality at 2 year |
| 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. |
Countries
China
Contacts
Primary ContactYang XU
Outcome results
None listed