Status:
UNKNOWN
TCDαβ/CD45RA Haploidentical Transplantation in Children With Leukemia
Lead Sponsor:
Shanghai Children's Medical Center
Collaborating Sponsors:
Nanfang Hospital, Southern Medical University
Children's Hospital of Soochow University
Conditions:
Relapsed Pediatric ALL
Acute Graft-Versus-Host Disease (Gvhd) Grade IV (Diagnosis)
Eligibility:
All Genders
2-18 years
Phase:
NA
Brief Summary
This is a multi-center clinical study in China using CliniMACS TCRα/β+ and CD45RA+ T cell depleted stem cell grafts from haploidentical donors for hematopoietic stem cell transplantation in children.
Detailed Description
This clinical study will the CliniMACS TCRα/β and CD45RA Systems to deplete TCRα/β+ and CD45RA+ cells from the mobilized peripheral blood stem cells of a haploidentical donors to treat pediatric patie...
Eligibility Criteria
Inclusion
- Pediatric patients with hematological malignancies in complete remission (CR), partial remission (PR) or with stable disease
- Acute myeloid leukemia (AML):
- Patients with high-risk AML in CR1 Patients with relapsed or primary therapy-refractory AML
- Acute lymphoid leukemia (ALL):
- Patients with high-risk ALL in CR1 Patients with relapsed or primary refractory ALL
Exclusion
- Age \>18 years or \<8 weeks
- Patients with progressive disease prior HCT
- \<3 months after preceding hematopoietic cell transplantation (HCT)
- History of neurological impairment (active seizures, severe peripheral neuropathy, signs of leukencephalopathy, active CNS infection)
- Fungal infections with radiological and clinical progression
- Liver function abnormalities with bilirubin \>2 mg/dL and elevation of transaminases higher than 400 U/L
- Chronic active viral hepatitis
- Ejection fraction \<40% or shortening fraction \<25% on echocardiography
- Patients with \> grade II hypertension by Common Toxicity Criteria (CTC)
- Creatinine clearance below threshold defined for stem cell transplantation according to local clinical standard
- Respiratory failure necessitating supplemental oxygen
- HIV infection
- Concurrent severe or uncontrolled medical disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which by assessment of the treating physician could compromise participation in the study
- Patients with a history of psychiatric illness or a condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism/drug addiction)
- Patients unwilling or unable to comply with the protocol or unable to give informed consent
- Treatment with any investigational product within 4 weeks prior to study treatment (transfusion of the IMP)
Key Trial Info
Start Date :
November 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 8 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04033627
Start Date
November 10 2020
End Date
May 8 2024
Last Update
September 29 2022
Active Locations (1)
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1
Shanghai Children's Medical Center
Shanghai, China