CAR T-cell Therapy in Patients With Renal Dysfunction
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthside Hospital, Inc.
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Fludarabine
- Cyclophosphamide
Treatment groups
20 Participants
are divided into 3 treatment groupsSponsors and collaborators
Northside Hospital, Inc.
Lead sponsor
Blood and Marrow Transplant Group of Georgia
Collaborator
Source ClinicalTrials.gov