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

RECRUITINGPhase 3Sponsored by The First Affiliated Hospital of Soochow University
Actively Recruiting
PhasePhase 3
SponsorThe First Affiliated Hospital of Soochow University
Started2024-04-01
Est. completion2028-03-31
Eligibility
Healthy vol.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.

Eligibility

Healthy volunteers accepted
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)

Conditions4

Acute T Cell Lymphoblastic LeukemiaCancerCord BloodHaploidentical Hematopoietic Stem Cell Transplantation

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