RecruitingPhase 2NCT05909059
CAR T-cell Therapy in Patients With Renal Dysfunction
Lymphodepleting Chemotherapy With Fludarabine and Cyclophosphamide Prior to Infusion of CAR T Cell Therapy in Patients With Moderate-Severe Renal Dysfunction
Sponsor
Northside Hospital, Inc.
Enrollment
20 participants
Start Date
Nov 18, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria3
- 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
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05909059
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