Study of Combined Kidney and Blood Stem Cell Transplant From a Brother or Sister Donor (OneLegacy)
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|ClinicalTrials.gov Identifier: NCT03707262|
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : December 4, 2019
The purpose of this study is to find out if an investigational treatment will allow kidney transplant recipients to better accept their new kidney and stop immunosuppressive medicines. This study is for kidney transplant recipients who receive a kidney from a sibling donor.
The investigational treatment is started after kidney transplant. It begins with a regimen of a drug called rabbit anti-thymocyte globulin (rATG) combined with radiation therapy (known as total lymphoid irradiation, or TLI) to the lymph nodes and spleen. This is followed by an infusion of blood stem cells, which will be donated by the same sibling who donated their kidney. Researchers think that this treatment allows immune cells from the donor and recipient to live side by side, a condition referred to as "mixed chimerism." Mixed chimerism may help create a state of "tolerance" in kidney transplant recipients in which all immunosuppressive medications can be stopped without rejection of the transplanted kidney.
This study will test whether (1) the investigational treatment will allow patients to stop immunosuppressive medications after their kidney transplant and (2) if the treatment impacts the rate of kidney rejection and the side effects of immunosuppressive medications.
|Condition or disease||Intervention/treatment||Phase|
|Renal Transplant Rejection Tolerance Kidney Transplant||Biological: Donor CD34+ and CD3+ cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Donor Chimerism and Graft Survival Following Combined HLA-Identical Sibling Living Donor Kidney and Hematopoietic Stem Cell Transplantation Utilizing a Conditioning Regimen of Total Lymphoid Irradiation and Rabbit Anti-Thymocyte Globulin|
|Actual Study Start Date :||November 6, 2019|
|Estimated Primary Completion Date :||February 2023|
|Estimated Study Completion Date :||February 2025|
Experimental: Donor CD34+ and CD3+ cell infusion
The investigational products are (1) an intravenous infusion of granulocyte colony-stimulating factor (GCSF)-mobilized, Miltenyi-enriched CD34+ cells (≥ 5 million cells per kilogram) followed by (2) an infusion of CD3+ cells (5 million cells per kilogram) from an HLA-identical sibling living donor.
The cells are infused around Day 11 post-transplant after the following pre-conditioning regimen:
Biological: Donor CD34+ and CD3+ cells
Infusion of GCSF-mobilized, Miltenyi-enriched CD34+ hematopoietic stem/progenitor cells (HSPCs) (≥ 5 million cells/kg) and CD3+ cells (5 million cells/kg) from an HLA-identical sibling living donor, following pre-conditioning regimen of rATG and TLI.
- Withdrawal from immunosuppressive drugs [ Time Frame: 12 months post-kidney transplant ]Percentage of subjects free from all immunosuppressive drugs at 12 months after kidney transplantation.
- Graft rejection [ Time Frame: 48 months post-kidney transplant ]Percentage of patients with graft rejection within 48 months post-transplant defined as (1) meets Banff criteria for rejection either on protocol biopsy or biopsy performed to confirm clinical suspicion of rejection or (2) clinical suspicion of rejection demonstrating response to corticosteroids in absence of biopsy when confirmatory biopsy contraindicated or declined.
- Time to graft rejection [ Time Frame: 48 months post-kidney transplant ]Time to graft rejection
- Graft failure [ Time Frame: 48 months post-kidney transplant ]Percentage of patients with graft failure as determined by return to dialysis and/or re-transplantation.
- Time to graft failure [ Time Frame: 48 months post-kidney transplant ]Time to graft failure
- Survival [ Time Frame: 12, 24, 36, and 48 months post-kidney transplant ]Percentage of subjects alive at 12, 24, 36, and 48 months post-kidney transplant
- Time to death [ Time Frame: 48 months post-kidney transplant ]Time to death (months post-transplant)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707262
|Contact: Dana Levin||(310) email@example.com|
|United States, California|
|University of California, Los Angeles||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Dana Levin, MPH 310-794-8893 DLevin@mednet.ucla.edu|
|Contact: Jenny Lester, MPH 310-794-9728 firstname.lastname@example.org|
|Principal Investigator: Jeffrey Veale, MD|
|Principal Investigator:||Jeffrey Veale, MD||University of California, Los Angeles|