Haplo-cord HCT vs. Haplo-HCT for T-ALL Patients
Recruiting now · Phase 3
Conditions studied: Acute T Cell Lymphoblastic Leukemia, Haploidentical Hematopoietic Stem Cell Transplantation, Cord Blood
In brief
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.
Key facts
- Study ID
- NCT06381817
- Run by
- The First Affiliated Hospital of Soochow University
- People needed
- 146
- Starts
- 2024-04-01
- Expected to finish
- 2028-03-31
- Last updated by the study team
- 2024-04-26
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)
Full record on ClinicalTrials.gov
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