Overview
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.
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 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 of this new In Vitro T cell depletion technology in China.
The investigators will monitor the incidence of grade I acute GVHD until Day 100 post-transplantation, incidence and severity of chronic GVHD after 1 year and 2 years, incidence of NRM at all visits throughout the study, and graft failure from Day 0 to Day 28 at the same time.
Eligibility
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)