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TCDαβ/CD45RA Haploidentical Transplantation in Children With Leukemia

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
In Vitro T cells depletion using CliniMCAS system
Sponsored by
Shanghai Children's Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed Pediatric ALL focused on measuring In Vitro T cell depletion, haploidentical transplantation, GVHD, leukemia, TCRab, CD45RA, CliniMACS

Eligibility Criteria

2 Months - 18 Years (Child, Adult)All SexesDoes not accept 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)

Sites / Locations

  • Shanghai Children's Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

In Vitro T cell depletion

Arm Description

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.

Outcomes

Primary Outcome Measures

Log number of In Vitro T cells depletion
Log number of In Vitro T cells depletion using CliniMACS TCRab/CD45RA system.
Incidence of grade II-IV acute GVHD
Incidence of grade II-IV acute graft-versus-host disease (GVHD) until Day 100 post-transplantation.

Secondary Outcome Measures

Grade I aGVHD
Incidence of grade I acute GVHD until Day 100 post-transplantation
cGVHD
Incidence and severity of chronic GVHD in 1 year and 2 years
NRM
Incidence of NRM at all visits throughout the study
Graft failure
incidence of Graft failure from Day 0 to Day 28

Full Information

First Posted
June 12, 2019
Last Updated
September 28, 2022
Sponsor
Shanghai Children's Medical Center
Collaborators
Nanfang Hospital, Southern Medical University, Children's Hospital of Soochow University, Chinese University of Hong Kong, Miltenyi Biomedicine GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04033627
Brief Title
TCDαβ/CD45RA Haploidentical Transplantation in Children With Leukemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2020 (Actual)
Primary Completion Date
July 18, 2022 (Actual)
Study Completion Date
May 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Children's Medical Center
Collaborators
Nanfang Hospital, Southern Medical University, Children's Hospital of Soochow University, Chinese University of Hong Kong, Miltenyi Biomedicine GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed Pediatric ALL, Acute Graft-Versus-Host Disease (Gvhd) Grade IV (Diagnosis), Relapsed Pediatric AML
Keywords
In Vitro T cell depletion, haploidentical transplantation, GVHD, leukemia, TCRab, CD45RA, CliniMACS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
In Vitro T cell depletion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
In Vitro T cells depletion using CliniMCAS system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Log number of In Vitro T cells depletion
Description
Log number of In Vitro T cells depletion using CliniMACS TCRab/CD45RA system.
Time Frame
One week
Title
Incidence of grade II-IV acute GVHD
Description
Incidence of grade II-IV acute graft-versus-host disease (GVHD) until Day 100 post-transplantation.
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
Grade I aGVHD
Description
Incidence of grade I acute GVHD until Day 100 post-transplantation
Time Frame
up to 3 months
Title
cGVHD
Description
Incidence and severity of chronic GVHD in 1 year and 2 years
Time Frame
2 years
Title
NRM
Description
Incidence of NRM at all visits throughout the study
Time Frame
1 year
Title
Graft failure
Description
incidence of Graft failure from Day 0 to Day 28
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
luo chengjuan
Phone
+86 021 38626161
Ext
82030
Email
luochengjuan@scmc.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Chen
Organizational Affiliation
Shanghai Children's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Children's Medical Center
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Chen
Phone
18930830632
Email
chenjing@scmc.com.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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TCDαβ/CD45RA Haploidentical Transplantation in Children With Leukemia

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