Clinical trial NCT06381817: Haplo-cord HCT vs. Haplo-HCT for T-ALL Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acute T Cell Lymphoblastic Leukemia
Haploidentical Hematopoietic Stem Cell Transplantation
Cord Blood
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Soochow University
name: Ruijin Hospital
name: Nanfang Hospital, Southern Medical University
name: Fujian Medical University Union Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: Wuhan Union Hospital, China
name: Zhejiang University
First posted: 2024-04-24
Enrollment: 146
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Progression-free survival
timeFrame: 2 years after randomization
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years after randomization
measure: Cumulative incidence of relapse
timeFrame: 2 years after randomization
measure: Non-relapse mortality
timeFrame: 2 years after randomization
measure: Adverse events
timeFrame: 2 years after randomization
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Yang XU
role: PRINCIPAL_INVESTIGATOR
References: