Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
146 participants
INTERVENTIONAL
2024-04-01
2028-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Haplo-cord HCT
Patients enrolled in this arm will receive a coinfusion of cord blood unit in addition to a typical haploidentical hematopoietic cell transplantation
Haplo-cord HCT
Haploidentical hematopoietic cell transplantation will be performed with coinfusion of an unrelated cord blood unit
Haplo-HCT
Patients enrolled in this arm will receive a typical haploidentical hematopoietic cell transplantation
Haplo-HCT
Hematopoietic cell transplantation will be performed with a haploidentical donor
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
ALL
No
Sponsors
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Children's Hospital of Soochow University
OTHER
Ruijin Hospital
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Fujian Medical University Union Hospital
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Zhejiang University
OTHER
The First Affiliated Hospital of Soochow University
OTHER
Responsible Party
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Principal Investigators
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Yang XU
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Soochow University
Locations
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024112
Identifier Type: -
Identifier Source: org_study_id
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