CAR T-cell Therapy in Patients With Renal Dysfunction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fludarabine, Cyclophosphamide.
- Who it may be relevant to
- Registry conditions: Non-hodgkin Lymphoma,B Cell, Multiple Myeloma, Acute Lymphoblastic Leukemia, Adult. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Lymphodepleting Chemotherapy With Fludarabine and Cyclophosphamide Prior to Infusion of CAR T Cell Therapy in Patients With Moderate-Severe Renal Dysfunction
Overview
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.
Interventions
- Drug Fludarabine
Received IV on Days -5 to -3 before CAR T cell therapy - Drug Cyclophosphamide
Received IV on Days -5 to -3 before CAR T cell therapy
Primary outcome measures
- Occurrence of CRS [Time frame: 90 days]
- Occurrence of ICANS [Time frame: 90 days]
- Occurrence of Cytopenias [Time frame: 90 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Caitlin Guzowski — Atlanta
Identifiers
NCT: NCT05909059 · NSH 1375