TCDαβ/CD45RA Haploidentical Transplantation in Children With Leukemia

Sponsor

Shanghai Children's Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04033627

Collaborator

Nanfang Hospital of Southern Medical University (Other), Children's Hospital Of Soochow University (Other), Chinese University of Hong Kong (Other), Miltenyi Biomedicine GmbH (Industry)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Relapsed Pediatric ALL Acute Graft-Versus-Host Disease (Gvhd) Grade IV (Diagnosis) Relapsed Pediatric AML	Procedure: In Vitro T cells depletion using CliniMCAS system	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multi-center Prospective 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 With Leukemia

Anticipated Study Start Date :

Sep 1, 2019

Anticipated Primary Completion Date :

Aug 31, 2021

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: In Vitro T cell depletion 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.	Procedure: In 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.

Arm

Intervention/Treatment

Experimental: In Vitro T cell depletion

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.

Procedure: In 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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)