Acute Lymphoblastic Leukemia, Adult, Multiple Myeloma, Non-hodgkin Lymphoma,B Cell
Conditions
Brief 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.
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
Sponsors
Northside Hospital, Inc.
Blood and Marrow Transplant Group of Georgia
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of CRS | 90 days | Collection of maximum grade of CRS (based on CTCAE v5) and when this event occurs post CAR T cell therapy infusion |
| Occurrence of ICANS | 90 days | Collection of maximum grade of ICANs (based on CTCAE v5) and when this event occurs after CAR T cell therapy infusion |
| Occurrence of Cytopenias | 90 days | Collection of grade 3 or higher (based on CTCAE v5) cytopenias not resolved by Day 30 post CAR T cell infusion |
Countries
United States
Contacts
CONTACTMelhem Solh, MD
CONTACTCaitlin Guzowski, MBA, MHA
Outcome results
None listed