RECRUITING

BHB & CAR-T for Lymphomas

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

The aim of this study is to assess the feasibility of β-hydroxybutyrate (BHB) supplementation in individuals who are receiving therapy for lymphoma with standard-of-care anti-CD19 CAR T-cells (CAR-T) to determine whether BHB supplementation is safe and tolerable in this patient population. Additionally, this study will determine whether BHB supplementation leads to changes the gut microbiome and peripheral blood mononuclear cells (PBMCs). BHB supplementation will be performed through oral administration of HVMN Ketone-IQ, a commercially available BHB supplement, with an active ingredient of R- 1,3-Butanediol, which is converted to BHB.

Official Title

Preliminary Investigation of Β-hydroxybutyrate Supplementation for Lymphoma Patients Receiving Anti-CD19 CAR T-cells

Quick Facts

Study Start:2025-01-07
Study Completion:2026-10-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06610344

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. * Age of 18 years or older
  2. * History of pathologically-confirmed large B-cell lymphoma (LBCL)
  3. * Planned treatment with a commercially available anti-CD19 CAR-T product (Yescarta or Kymriah)
  4. * Eligible for and with adequate organ function (investigator discretion) and performance status (ECOG PS 2 or less) for standard of care, anti-CD19 CAR-T
  5. * Not enrolled on a clinical trial of bridging therapy prior to CAR-T
  6. * Patients must have a PET/CT scan (preferred), diagnostic CT scan, or MRI with at least one bi-dimensionally measurable lesion (≥ 1.5 cm for nodal lesions or ≥ 1cm for extra- nodal lesions in largest dimension by low-dose computerized tomography \[CT\] scan with FDG-uptake ≥ liver) documented prior to leukapheresis for CAR-T manufacturing
  7. * Resolution of toxicities from prior therapy to a grade that does not contraindicate trial participation in the opinion of the investigator
  8. * Can provide informed consent
  9. * Willing to comply with all study procedures and available for the duration of the study
  1. * Subject is pregnant or breast feeding
  2. * History of allergy to energy drinks
  3. * History of inflammatory bowel disease
  4. * History of type 1 diabetes mellitus or requirement for insulin
  5. * History of chronic kidney disease with an eGFR \< 30 mL/min/1.73m2
  6. * Additional second primary malignancy for which the subject is receiving active therapy or that will impede the ability of the investigator to assess lymphoma response

Contacts and Locations

Study Contact

Brittany Koch, MPH
CONTACT
215-615-4312
Brittany.Koch@pennmedicine.upenn.edu
Kaitlin Kennard, BSN, RN
CONTACT
267-804-4080
Kaitlin.Kennard@pennmedicine.upenn.edu

Principal Investigator

Elise Chong, MD
PRINCIPAL_INVESTIGATOR
Abramson Cancer Center at the University of Pennsylvania

Study Locations (Sites)

Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Abramson Cancer Center at Penn Medicine

  • Elise Chong, MD, PRINCIPAL_INVESTIGATOR, Abramson Cancer Center at the University of Pennsylvania

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 Date2025-01-07
Study Completion Date2026-10-15

Study Record Updates

Study Start Date2025-01-07
Study Completion Date2026-10-15

Terms related to this study

Additional Relevant MeSH Terms

  • Large B-cell Lymphoma