Acute Graft-Versus-Host Disease (Gvhd) Grade IV (Diagnosis), Relapsed Pediatric ALL, Relapsed Pediatric AML
Conditions
Keywords
In Vitro T cell depletion, haploidentical transplantation, GVHD, leukemia, TCRab, CD45RA, CliniMACS
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 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.
Interventions
PROCEDUREIn Vitro T cells depletion using CliniMCAS system
Use the CliniMACS TCRα/β and CD45 Systems to deplete TCRα/β+ and CD45RA+ cells from the mobilized peripheral blood stem cells of a haploidentical donor in patients with leukemia.
Sponsors
Nanfang Hospital, Southern Medical University
Children's Hospital of Soochow University
Chinese University of Hong Kong
Miltenyi Biomedicine GmbH
Shanghai Children's Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 18 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Log number of In Vitro T cells depletion | One week | Log number of In Vitro T cells depletion using CliniMACS TCRab/CD45RA system. |
| Incidence of grade II-IV acute GVHD | up to 3 months | Incidence of grade II-IV acute graft-versus-host disease (GVHD) until Day 100 post-transplantation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grade I aGVHD | up to 3 months | Incidence of grade I acute GVHD until Day 100 post-transplantation |
| cGVHD | 2 years | Incidence and severity of chronic GVHD in 1 year and 2 years |
| NRM | 1 year | Incidence of NRM at all visits throughout the study |
| Graft failure | 1 month | incidence of Graft failure from Day 0 to Day 28 |
Countries
China
Contacts
Primary Contactluo chengjuan
Outcome results
None listed