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Lymphodepleting Chemotherapy With Fludarabine and Cyclophosphamide Prior to Infusion of CAR T Cell Therapy in Patients With Moderate-Severe Renal Dysfunction


Description

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.

Trial Eligibility

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

Study Info

Organization

Northside Hospital, Inc.


Primary Outcome

Occurrence of CRS


Outcome Timeframe 90 days

NCTID NCT05909059

Phases PHASE2

Primary Purpose TREATMENT

Start Date 2024-11-18

Completion Date 2025-08-31

Enrollment Target 20

Interventions

DRUG Fludarabine

DRUG Cyclophosphamide

Locations Recruiting

Caitlin Guzowski

United States, Georgia, Atlanta


Interested in joining this trial?

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