TCDαβ/CD45RA Haploidentical Transplantation in Children With Leukemia

Relapsed Pediatric ALL Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04033627
• Other study ID #: TCD Haplo
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2020
• Est. completion date: May 8, 2024

Study information

• Verified date: September 2022
• Source: Shanghai Children's Medical Center
• Contact: luo chengjuan
• Phone: +86 021 38626161
• Email: luochengjuan[@]scmc.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 8, 2024
• Est. primary completion date: July 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Procedure:
• In Vitro T cells depletion using CliniMCAS system
Use the CliniMACS TCRa/ß and CD45 Systems to deplete TCRa/ß+ and CD45RA+ cells from the mobilized peripheral blood stem cells of a haploidentical donor in patients with leukemia.

Locations

Country	Name	City	State
China	Shanghai Children's Medical Center	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Shanghai Children's Medical Center	Children's Hospital Of Soochow University, Chinese University of Hong Kong, Miltenyi Biomedicine GmbH, Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Log number of In Vitro T cells depletion	Log number of In Vitro T cells depletion using CliniMACS TCRab/CD45RA system.	One week
Primary	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	Grade I aGVHD	Incidence of grade I acute GVHD until Day 100 post-transplantation	up to 3 months
Secondary	cGVHD	Incidence and severity of chronic GVHD in 1 year and 2 years	2 years
Secondary	NRM	Incidence of NRM at all visits throughout the study	1 year
Secondary	Graft failure	incidence of Graft failure from Day 0 to Day 28	1 month