An Open-label, Multicenter, Randomized, Phase 3 Trial to Assess the Efficacy and Safety of Coinfusion With Unrelated Cord Blood Unit for Patients With Acute Myeloid Leukemia Undergoing Haploidentical Hematopoietic Cell Transplantation
Sponsor study identifier
interventional
134
1 country
5
Study Start
June 1, 2017
Actual (reported)Primary Completion
December 31, 2022
Actual (reported)Study Completion
March 31, 2023
Actual (reported)Patients who have acute myeloid leukemia and will undergo haplo-identical donor hematopoeitic cell transplantation (haplo HCT) are potential candidates of this trial. Participants will randomized into two arms: Arm A will undergo a typical haplo HCT, while Arm B will receive an coinfusion of an unrelated cord blood unit (haplo-cord HCT) in addition to Arm A. Progression-free survival, overall survival, cumulative incidence of relapse and nonrelapse mortality will be recorded as endpoints.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2017
Actual (reported)October 22, 2018
Actual (reported)October 25, 2018
Actual (reported)December 31, 2022
Actual (reported)March 31, 2023
Actual (reported)Overall survival
estimated overall survival at 3 year
3 year after randomization
Progression-free survival
3 year after randomization
Cumulative incidence of relapse
3 year after randomization
Cumulative incidence of non-relapse mortality
3 year after randomization
people enrolled in this arm will receive a typical haploidentical donor HCT
people enrolled in this arm will receive a coinfusion of cord blood unit in addition to a typical haploidentical donor HCT
HCT will be performed with a haploidentical donor
Haploidentical donor HCT will be performed with coinfusion of unrelated cord blood unit
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The Second People's Hospital of Huai'an
Huai'an, Jiangsu, 223000, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Soochow Hopes Hematology Hospital
Suzhou, Jiangsu, 215100, China
Hygeia Suzhou Yongding Hospital
Suzhou, Jiangsu, 215200, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
Zhou B, Chen J, Liu T, Ye Y, Zhang Y, Ding Y, Liu H, Zhu M, Ma X, Li X, Zhao L, Lin Z, Huang H, Xu Y, Wu D. Haploidentical hematopoietic cell transplantation with or without an unrelated cord blood unit for adult acute myeloid leukemia: a multicenter, randomized, open-label, phase 3 trial. Signal Transduct Target Ther. 2024 May 6;9(1):108. doi: 10.1038/s41392-024-01820-5.
Depei Wu, M.D., Ph.D.
The First Affiliated Hospital of Soochow University
134 participants (actual enrollment reported by the registry).
First Submitted
October 22, 2018
First Posted
October 25, 2018
Study Start
June 1, 2017
Actual (reported)Study of DAC Combined With HAAG Regimen in Newly Diagnosed Younger AML Patients
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2022
Actual (reported)Study Completion
March 31, 2023
Actual (reported)Last Updated
June 27, 2023
Record last verified: 2023-06
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Source: ClinicalTrials.gov.
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