TCDαβ/CD45RA Haploidentical Transplantation in Children With Leukemia

Launched by SHANGHAI CHILDREN'S MEDICAL CENTER · Jul 23, 2019

Keywords

ClinConnect Summary

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 patients who were suffuring form relapsed or refactory leukemia.

Aming to evaluate the safety/tolerability and feasibility of haploidentical PBSC grafts depleted of TCRα/β+ and CD45RA+ cells using the CliniMACS TCRαβ/CD45RA System in pediatric patients with hematological malignancies diseases. And the incidence of grade II-IV acute graft-versus-host disease (GVHD) until Day 100 post-transplantation...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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)