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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06381817
Other study ID # 2024112
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 1, 2024
Est. completion date March 31, 2028

Study information

Verified date April 2024
Source The First Affiliated Hospital of Soochow University
Contact Yang XU
Phone 86+051267781850
Email xuyang1020@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 146
Est. completion date March 31, 2028
Est. primary completion date March 31, 2028
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms

  • Cord Blood
  • Haploidentical Hematopoietic Stem Cell Transplantation
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Biological:
Haplo-cord HCT
Haploidentical hematopoietic cell transplantation will be performed with coinfusion of an unrelated cord blood unit
Haplo-HCT
Hematopoietic cell transplantation will be performed with a haploidentical donor

Locations

Country Name City State
China The First Affiliated Hospital of Soochow University Suzhou Jiangsu

Sponsors (8)

Lead Sponsor Collaborator
The First Affiliated Hospital of Soochow University Children's Hospital of Soochow University, First Affiliated Hospital Xi'an Jiaotong University, Fujian Medical University Union Hospital, Nanfang Hospital, Southern Medical University, Ruijin Hospital, Wuhan Union Hospital, China, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival estimated progression-free survival at 2 year 2 years after randomization
Secondary Overall survival estimated overall survival at 2 year 2 years after randomization
Secondary Cumulative incidence of relapse estimated cumulative incidence of relapse at 2 year 2 years after randomization
Secondary Non-relapse mortality estimated non-relapse mortality at 2 year 2 years after randomization
Secondary Adverse events Number of participants with adverse events. Frequencies of toxicities based on Common Terminology Criteria for Adverse Events (CTCAE) will be tabulated. 2 years after randomization
See also
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Recruiting NCT06423131 - Prospective Clinical Trial for Children With TCRαβ Depleted vs Traditional Haplo Identicle HSCT N/A
Recruiting NCT02014506 - Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation in Children and Adolescents Phase 1/Phase 2
Recruiting NCT05166967 - Individualized Dose Study of ATG in Haploidentical Hematopoietic Stem Cell Transplantation Phase 4
Active, not recruiting NCT04778618 - Individualized Dose Study of ATG in Haploidentical Hematopoietic Stem Cell Transplantation Phase 2
Completed NCT03236220 - Effect of NAC on the Hematopoietic Reconstitution After Haploidentical Hematopoietic Stem Cell Transplantation Phase 2