Trials / Unknown
UnknownNCT04033627
TCDαβ/CD45RA Haploidentical Transplantation in Children With Leukemia
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Shanghai Children's Medical Center · Academic / Other
- Sex
- All
- Age
- 2 Months – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Relapsed Pediatric ALL
- Acute Graft-Versus-Host Disease (Gvhd) Grade IV (Diagnosis)
- Relapsed Pediatric AML
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-11-10
- Primary completion
- 2022-07-18
- Completion
- 2024-05-08
- First posted
- 2019-07-26
- Last updated
- 2022-09-29
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04033627. Inclusion in this directory is not an endorsement.