Status:
RECRUITING
BHB & CAR-T for Lymphomas
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Conditions:
Large B-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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) ...
Eligibility Criteria
Inclusion
- Age of 18 years or older
- History of pathologically-confirmed large B-cell lymphoma (LBCL)
- Planned treatment with a commercially available anti-CD19 CAR-T product (Yescarta or Kymriah)
- 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
- Not enrolled on a clinical trial of bridging therapy prior to CAR-T
- 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
- Resolution of toxicities from prior therapy to a grade that does not contraindicate trial participation in the opinion of the investigator
- Can provide informed consent
- Willing to comply with all study procedures and available for the duration of the study
Exclusion
- Subject is pregnant or breast feeding
- History of allergy to energy drinks
- History of inflammatory bowel disease
- History of type 1 diabetes mellitus or requirement for insulin
- History of chronic kidney disease with an eGFR \< 30 mL/min/1.73m2
- 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
Key Trial Info
Start Date :
January 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2026
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06610344
Start Date
January 7 2025
End Date
October 15 2026
Last Update
February 12 2025
Active Locations (1)
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1
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104