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Trial Title:
Haplo-cord HCT vs. Haplo-HCT for T-ALL Patients
NCT ID:
NCT06381817
Condition:
Acute T Cell Lymphoblastic Leukemia
Haploidentical Hematopoietic Stem Cell Transplantation
Cord Blood
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Haplo-cord HCT
Description:
Haploidentical hematopoietic cell transplantation will be performed with coinfusion of an
unrelated cord blood unit
Arm group label:
Haplo-cord HCT
Intervention type:
Biological
Intervention name:
Haplo-HCT
Description:
Hematopoietic cell transplantation will be performed with a haploidentical donor
Arm group label:
Haplo-HCT
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.
Criteria for 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)
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yang XU
Phone:
86+051267781850
Email:
xuyang1020@126.com
Investigator:
Last name:
Yang Xu
Email:
Principal Investigator
Start date:
April 1, 2024
Completion date:
March 31, 2028
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Collaborator:
Agency:
Children's Hospital of Soochow University
Agency class:
Other
Collaborator:
Agency:
Ruijin Hospital
Agency class:
Other
Collaborator:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Collaborator:
Agency:
Fujian Medical University Union Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital Xi'an Jiaotong University
Agency class:
Other
Collaborator:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Collaborator:
Agency:
Zhejiang University
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06381817
