TCDαβ/CD45RA Haploidentical Transplantation in Children With Leukemia

NCT04033627 | Unknown

• 1 other identifier: TCD Haplo
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Log number of In Vitro T cells depletion

  Log number of In Vitro T cells depletion using CliniMACS TCRab/CD45RA system.

  One week

• Incidence of grade II-IV acute GVHD

  Incidence of grade II-IV acute graft-versus-host disease (GVHD) until Day 100 post-transplantation.

  up to 3 months

Secondary Outcomes (4)

• Grade I aGVHD

  up to 3 months

• cGVHD

  2 years

• NRM

  1 year

• Graft failure

  1 month

Study Arms (1)

In Vitro T cell depletion

EXPERIMENTAL

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

Interventions

In Vitro T cells depletion using CliniMCAS system PROCEDURE

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.

In Vitro T cell depletion

Eligibility Criteria

• Age: 2 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Children's Medical Center: lead
• Nanfang Hospital, Southern Medical University: collaborator
• Children's Hospital of Soochow University: collaborator
• Chinese University of Hong Kong: collaborator
• Miltenyi Biomedicine GmbH: collaborator

Study Sites (1)

Shanghai Children's Medical Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Graft vs Host Disease; Disease; Leukemia

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jing Chen

  Shanghai Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

luo chengjuan

CONTACT

+86 021 38626161; luochengjuan@scmc.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: July 26, 2019
• Study Start: November 10, 2020
• Primary Completion: July 18, 2022
• Study Completion: May 8, 2024
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)