TCDαβ/CD45RA Haploidentical Transplantation in Children With Leukemia
NCT ID: NCT04033627
Last Updated: 2022-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
30 participants
INTERVENTIONAL
2020-11-10
2024-05-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation in Children and Adolescents
NCT02014506
Expanded Access Protocol (EAP) Using the CliniMACS® Device for Pediatric Haplocompatible Donor Stem Cell Transplant
NCT01200017
Allogeneic Stem Cell Transplantation in Pediatric Patients With Malignant and Non-malignant High-risk Diseases
NCT00945126
Safety and Preliminary Efficacy of Donor-derived Anti-leukemia Cytotoxic T Lymphocytes for the Prevention of Leukemia Relapse in Children Given Haploidentical Hematopoietic Stem Cell Transplantation
NCT06865352
Haplo-cord HCT vs. Haplo-HCT for T-ALL Patients
NCT06381817
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
2 Months
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nanfang Hospital, Southern Medical University
OTHER
Children's Hospital of Soochow University
OTHER
Chinese University of Hong Kong
OTHER
Miltenyi Biomedicine GmbH
INDUSTRY
Shanghai Children's Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jing Chen
Role: PRINCIPAL_INVESTIGATOR
Shanghai Children's Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Shanghai Children's Medical Center
Shanghai, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TCD Haplo
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.