Back to resultsCAR T-cell Therapy in Patients With Renal Dysfunction
Primary Purpose
Non-hodgkin Lymphoma,B Cell, Multiple Myeloma, Acute Lymphoblastic Leukemia, Adult
Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fludarabine
Cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Non-hodgkin Lymphoma,B Cell
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
Sites / Locations
- Caitlin Guzowski
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Moderate Renal Dysfunction
Severe Renal Dysfunction
Dialysis Participants
Arm Description
Moderate renal dysfunction will receive a 20% dose reduction of fludarabine and no dose reduction for cyclophosphamide.
Several renal dysfunction will receive a 40% dose reduction of fludarabine and no dose reduction for cyclophosphamide.
Participants on dialysis will receive a 50% dose reduction of fludarabine and a 25% dose reduction of cyclophosphamide.
Outcomes
Primary Outcome Measures
Occurrence of CRS
Collection of maximum grade of CRS (based on CTCAE v5) and when this event occurs post CAR T cell therapy infusion
Occurrence of ICANS
Collection of maximum grade of ICANs (based on CTCAE v5) and when this event occurs after CAR T cell therapy infusion
Occurrence of Cytopenias
Collection of grade 3 or higher (based on CTCAE v5) cytopenias not resolved by Day 30 post CAR T cell infusion
Secondary Outcome Measures
Full Information
NCT ID
NCT05909059
First Posted
June 9, 2023
Last Updated
June 9, 2023
Sponsor
Northside Hospital, Inc.
Collaborators
Blood and Marrow Transplant Group of Georgia
1. Study Identification
Unique Protocol Identification Number
NCT05909059
Brief Title
CAR T-cell Therapy in Patients With Renal Dysfunction
Official Title
Lymphodepleting Chemotherapy With Fludarabine and Cyclophosphamide Prior to Infusion of CAR T Cell Therapy in Patients With Moderate-Severe Renal Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 31, 2023 (Anticipated)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northside Hospital, Inc.
Collaborators
Blood and Marrow Transplant Group of Georgia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-hodgkin Lymphoma,B Cell, Multiple Myeloma, Acute Lymphoblastic Leukemia, Adult
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Moderate Renal Dysfunction
Arm Type
Experimental
Arm Description
Moderate renal dysfunction will receive a 20% dose reduction of fludarabine and no dose reduction for cyclophosphamide.
Arm Title
Severe Renal Dysfunction
Arm Type
Experimental
Arm Description
Several renal dysfunction will receive a 40% dose reduction of fludarabine and no dose reduction for cyclophosphamide.
Arm Title
Dialysis Participants
Arm Type
Experimental
Arm Description
Participants on dialysis will receive a 50% dose reduction of fludarabine and a 25% dose reduction of cyclophosphamide.
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Received IV on Days -5 to -3 before CAR T cell therapy
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Received IV on Days -5 to -3 before CAR T cell therapy
Primary Outcome Measure Information:
Title
Occurrence of CRS
Description
Collection of maximum grade of CRS (based on CTCAE v5) and when this event occurs post CAR T cell therapy infusion
Time Frame
90 days
Title
Occurrence of ICANS
Description
Collection of maximum grade of ICANs (based on CTCAE v5) and when this event occurs after CAR T cell therapy infusion
Time Frame
90 days
Title
Occurrence of Cytopenias
Description
Collection of grade 3 or higher (based on CTCAE v5) cytopenias not resolved by Day 30 post CAR T cell infusion
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melhem Solh, MD
Phone
404-255-1930
Email
msolh@bmtga.com
First Name & Middle Initial & Last Name or Official Title & Degree
Caitlin Guzowski, MBA, MHA
Phone
404-851-8523
Email
caitlin.guzowski@northside.com
Facility Information:
Facility Name
Caitlin Guzowski
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
12. IPD Sharing Statement
Learn more about this trial
CAR T-cell Therapy in Patients With Renal Dysfunction
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