RECRUITING

CAR T-cell Therapy in Patients With Renal Dysfunction

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-18
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05909059

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Receiving lymphodepleting chemotherapy prior to commercial CAR-T administration for multiple myeloma, leukemia, or lymphoma
  2. * Adequate bone marrow function to receive lymphodepleting chemotherapy
  3. * Renal function \</= 60mL/min/1.73m2
  4. * ECOG 0-2
  1. * Relative CNS disorders
  2. * 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
  3. * Use of therapeutic dose systemic corticosteroids (defined as \>20mg/day prednisone or equivalent) within 72 hours of CAR-T administration

Contacts and Locations

Study Contact

Melhem Solh, MD
CONTACT
404-255-1930
msolh@bmtga.com
Caitlin Guzowski, MBA, MHA
CONTACT
404-851-8523
caitlin.guzowski@northside.com

Study Locations (Sites)

Caitlin Guzowski
Atlanta, Georgia, 30342
United States

Collaborators and Investigators

Sponsor: Northside Hospital, Inc.

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 Registration Dates

Study Start Date2024-11-18
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2024-11-18
Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Non-hodgkin Lymphoma,B Cell
  • Multiple Myeloma
  • Acute Lymphoblastic Leukemia, Adult