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
Sponsor study identifier
interventional
146
1 country
1
Study Start
April 1, 2024
Actual (reported)Primary Completion
March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2024
Actual (reported)April 19, 2024
Actual (reported)April 24, 2024
Actual (reported)March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Progression-free survival
estimated progression-free survival at 2 year
2 years after randomization
Overall survival
2 years after randomization
Cumulative incidence of relapse
2 years after randomization
Non-relapse mortality
2 years after randomization
Adverse events
2 years after randomization
Patients enrolled in this arm will receive a coinfusion of cord blood unit in addition to a typical haploidentical hematopoietic cell transplantation
Patients enrolled in this arm will receive a typical haploidentical hematopoietic cell transplantation
Haploidentical hematopoietic cell transplantation will be performed with coinfusion of an unrelated cord blood unit
Hematopoietic cell transplantation will be performed with a haploidentical donor
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000, China
Yang XU
The First Affiliated Hospital of Soochow University
First Submitted
April 19, 2024
First Posted
April 24, 2024
Study Start
April 1, 2024
Actual (reported)Primary Completion
March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Prospective Clinical Trial for Children With TCRαβ Depleted vs Traditional Haplo Identicle HSCT
Contact the study team to confirm eligibility.
Study Completion
March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 26, 2024
Record last verified: 2024-04
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Source: ClinicalTrials.gov.
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