Large B-cell Lymphoma
Conditions
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) 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.
Interventions
DIETARY_SUPPLEMENTR-1,3-Butanediol
R-1,3-Butanediol 35 mL
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | From CART infusion to day 28 visit after CART | Assess number and severity of adverse events as well as number of patients who complete treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in gut microbiome | prior to BHB administration to day 28 visit after CART | compare changes in stool microbiome diversity assessed by stool 16S rRNA gene sequencing, metabolomics, qPCR |
| Changes in peripheral blood mononuclear cells | prior to BHB administration to day 28 visit after CART | compare changes in number and phenotype using flow cytometry, single cell RNAseq, qPCR |
Countries
United States
Contacts
CONTACTBrittany Koch, MPH
CONTACTKaitlin Kennard, BSN, RN
PRINCIPAL_INVESTIGATORElise Chong, MD
Abramson Cancer Center at the University of Pennsylvania
Outcome results
None listed