NCT05909059PHASE2Recruiting
CAR T-cell Therapy in Patients With Renal Dysfunction
Northside Hospital, Inc.
Start Date
11/18/2024
Completion Date
8/31/2027
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 Criteria
Age Range: 18 years to No maximum
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 hours of CAR-T administration
Interventions
DRUG
Fludarabine
DRUG
Cyclophosphamide
Conditions
Non-hodgkin Lymphoma,B CellMultiple MyelomaAcute Lymphoblastic Leukemia, Adult
Locations
Caitlin Guzowski
Atlanta, Georgia 30342
United States