Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Location contact
Brittany Koch, MPH
CONTACT
Kaitlin Kennard, BSN, RN
CONTACT
NCT Number: NCT06610344
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Brittany Koch, MPH
CONTACT
Kaitlin Kennard, BSN, RN
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
R-1,3-Butanediol 35 mL
Other names: Ketone
Time frame: 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
Time frame: 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
Time frame: prior to BHB administration to day 28 visit after CART
compare changes in number and phenotype using flow cytometry, single cell RNAseq, qPCR
Contact information is provided by the study sponsor or research team.
Brittany Koch, MPH
CONTACT
Kaitlin Kennard, BSN, RN
CONTACT
Abramson Cancer Center at Penn Medicine
Other
Preliminary Investigation of β-hydroxybutyrate Supplementation for Lymphoma Patients Receiving Anti-CD19 CAR T-cells
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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