Delayed Tolerance Through Mixed Chimerism
Sponsor: Massachusetts General Hospital • ClinicalTrials.gov ID: NCT05900401
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Check Eligibility →Description
This study will examine the safety and effectiveness of a bone marrow transplant after kidney transplant (from either a living or deceased donor). An investigational medication and other treatments will be given prior to and after the transplant to help protect the transplanted kidney from being attacked by the body's immune system
Interventions
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Bone Marrow Transplant
(Other)
Months-Years after standard transplant, patients will undergo bone marrow transplant (either from prospective collection of stem cells from their living donor, or from bone marrow collected at the time of deceased donation)
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Peripheral Blood Stem Cell Collection
(Procedure)
PBSC will be collected from the LD via leukapheresis 1-4 weeks before the scheduled HSCT. The donor will first undergo standard GCSF mobilization: GCSF (can be TBO-GCSF) dosed at 10 mcg/kg/d (rounded to nearest pre-filled syringe) administered subcutaneously daily for 5 consecutive days. On the 5th day, the donor will undergo standard large volume leukapheresis. The target yield will be 2-3 x 106 CD34+ cells / kg of actual recipient body weight. A maximum of 3 days of pheresis will be allowed. A minimum of 2 x 106 CD34+ cells / kg of actual recipient body weight will be required to proceed.
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Fludarabine
(Drug)
Fludarabine 15 mg/m2/day on days -5 to -3 (3 doses)
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Cyclophosphamide
(Drug)
Cyclophosphamide (CP) 30 mg/kg/day on days -5 and -4
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Rituximab
(Drug)
Rituximab on study day -6
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Siplizumab
(Drug)
Siplizumab (anti-CD2 mAb) on days, -2, -1, 0 and +1.
Eligibility criteria
Conditions
Locations
- Massachusetts General Hospital — Boston, Massachusetts, United States
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Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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