tcdαβ/cd45ra haploidentical transplantation in children with leukemia

Conditions: Relapsed Pediatric ALL; Acute Graft-Versus-Host Disease (Gvhd) Grade IV (Diagnosis); Relapsed Pediatric AML

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.

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 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)

Keywords: in vitro t cell depletion haploidentical transplantation gvhd leukemia tcrab cd45ra clinimacs