BHB & CAR-T for Lymphomas
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: R-1,3-Butanediol.
- Who it may be relevant to
- Registry conditions: Large B-cell Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Preliminary Investigation of β-hydroxybutyrate Supplementation for Lymphoma Patients Receiving Anti-CD19 CAR T-cells
Overview
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 supplement R-1,3-Butanediol
R-1,3-Butanediol 35 mL
Primary outcome measures
- Safety and tolerability [Time frame: From CART infusion to day 28 visit after CART]
Secondary outcome measures (2)
- Changes in gut microbiome [Time frame: prior to BHB administration to day 28 visit after CART]
- Changes in peripheral blood mononuclear cells [Time frame: prior to BHB administration to day 28 visit after CART]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Abramson Cancer Center at University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT06610344 · UPCC 41424 · IRB#856611