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
The First Affiliated Hospital of Soochow University
146 participants
Apr 1, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria7
- 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)
Interventions
Haploidentical hematopoietic cell transplantation will be performed with coinfusion of an unrelated cord blood unit
Hematopoietic cell transplantation will be performed with a haploidentical donor
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06381817