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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorThe First Affiliated Hospital of Soochow University

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Haplo-cord HCT
  • Haplo-HCT

Treatment groups

146 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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