Lymphodepleting Chemotherapy With Fludarabine and Cyclophosphamide Prior to Infusion of CAR T Cell Therapy in Patients With Moderate-Severe Renal Dysfunction
Northside Hospital, Inc.
Summary
This is a prospective, descriptive study designed to assess the feasibility of administering CAR T therapy among patients with moderate to severe renal impairment using dose adjusted lymphodepleting chemotherapy.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Receiving lymphodepleting chemotherapy prior to commercial CAR-T administration for multiple myeloma, leukemia, or lymphoma * Adequate bone marrow function to receive lymphodepleting chemotherapy * Renal function \</= 60mL/min/1.73m2 * ECOG 0-2 Exclusion Criteria: * Relative CNS disorders * Active uncontrolled infection or any other concurrent disease or medical condition that was deemed to interfere with the conduct of the study as judged by the investigator * Use of therapeutic dose systemic corticosteroids (defined as \>20mg/day prednisone or equivalent) within 72 h…
Interventions
- DrugFludarabine
Received IV on Days -5 to -3 before CAR T cell therapy
- DrugCyclophosphamide
Received IV on Days -5 to -3 before CAR T cell therapy
Location
- Caitlin GuzowskiAtlanta, Georgia