CAR T-cell Therapy in Patients With Renal Dysfunction

March 29, 2024 updated by: Northside Hospital, Inc.

Lymphodepleting Chemotherapy With Fludarabine and Cyclophosphamide Prior to Infusion of CAR T Cell Therapy in Patients With Moderate-Severe Renal Dysfunction

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Caitlin Guzowski

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moderate Renal Dysfunction
Moderate renal dysfunction will receive a 20% dose reduction of fludarabine and no dose reduction for cyclophosphamide.
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
Experimental: Severe Renal Dysfunction
Several renal dysfunction will receive a 40% dose reduction of fludarabine and no dose reduction for cyclophosphamide.
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
Experimental: Dialysis Participants
Participants on dialysis will receive a 50% dose reduction of fludarabine and a 25% dose reduction of cyclophosphamide.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of CRS
Time Frame: 90 days
Collection of maximum grade of CRS (based on CTCAE v5) and when this event occurs post CAR T cell therapy infusion
90 days
Occurrence of ICANS
Time Frame: 90 days
Collection of maximum grade of ICANs (based on CTCAE v5) and when this event occurs after CAR T cell therapy infusion
90 days
Occurrence of Cytopenias
Time Frame: 90 days
Collection of grade 3 or higher (based on CTCAE v5) cytopenias not resolved by Day 30 post CAR T cell infusion
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northside Hospital, Inc.

Collaborators

Blood and Marrow Transplant Group of Georgia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2024

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

June 9, 2023

First Submitted That Met QC Criteria

June 9, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSH 1375

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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