Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Young Adults
- Conditions
- Hematologic Diseases
- Interventions
- Device: CliniMACS TCR α/β Reagent Kit and CliniMACS CD19
- Registration Number
- NCT04249830
- Lead Sponsor
- Alice Bertaina
- Brief Summary
The purpose of the CliniMACS® TCRαβ-Biotin System and CliniMACS® CD19 is to improve the safety and efficacy of allogeneic HLA-partially matched related or unrelated donors HSCT when no matched donors are available, to treat malignant and nonmalignant disorders for which HSCT is the recommended best available therapy. Initially this device will be used in a single-center, open-label, single-arm, phase II clinical trial to evaluate the efficacy of haploidentical PBSC grafts depleted of TCRα/β+ and CD19+ cells using the CliniMACS® TCRαβ/CD19 System in children and adults with hematological and non-hematological malignancies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 204
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stem Cell Transplant -Malignant Allogeneic Stem Cell Transplant The participant with a malignancy will undergo a stem cell transplant using donor cells that have been manipulated through an investigational device. Participants will be followed for outcomes for two years. Stem Cell Transplant -Malignant CliniMACS TCR α/β Reagent Kit and CliniMACS CD19 The participant with a malignancy will undergo a stem cell transplant using donor cells that have been manipulated through an investigational device. Participants will be followed for outcomes for two years. Stem Cell Transplant - Non-Malignant Allogeneic Stem Cell Transplant The participant with a non-malignant disease will undergo a stem cell transplant using donor cells that have been manipulated through an investigational device. Participants will be followed for outcomes for two years. Stem Cell Transplant - Non-Malignant CliniMACS TCR α/β Reagent Kit and CliniMACS CD19 The participant with a non-malignant disease will undergo a stem cell transplant using donor cells that have been manipulated through an investigational device. Participants will be followed for outcomes for two years. Stem Cell Transplant - Compassionate Allogeneic Stem Cell Transplant Patients with malignant or non-malignant disorders who do not qualify for experimental arms but who may still benefit from participation in this study may be enrolled in this arm. Stem Cell Transplant - Compassionate CliniMACS TCR α/β Reagent Kit and CliniMACS CD19 Patients with malignant or non-malignant disorders who do not qualify for experimental arms but who may still benefit from participation in this study may be enrolled in this arm.
- Primary Outcome Measures
Name Time Method Number of participants with grade II-IV acute GvHD after HSCT Through Day 100 after HSCT
- Secondary Outcome Measures
Name Time Method Number of participants with secondary graft failure at after HSCT 1 and 2 year after HSCT Number of participants with grade III-IV acute GvHD after HSCT Through Day 100 after HSCT Incidence rate of primary graft failure after HSCT Day 42 after HSCT Incidence of moderate and severe chronic GvHD after HSCT 1 year after HSCT Leukemia-free survival after HSCT 1 and 2 years after HSCT Leukemia-free survival defined as the time of enrollment to disease relapse or death from any cause.
Trial Locations
- Locations (1)
Lucile Packard Children's Hospital
🇺🇸Palo Alto, California, United States
Lucile Packard Children's Hospital🇺🇸Palo Alto, California, United States