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Trial Title:
BHB & CAR-T for Lymphomas
NCT ID:
NCT06610344
Condition:
Large B-cell Lymphoma
Conditions: Official terms:
Lymphoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
R-1,3-Butanediol
Description:
R-1,3-Butanediol 35 mL
Arm group label:
R-1,3-Butanediol
Other name:
Ketone
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Abramson Cancer Center at University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Contact:
Last name:
Brittany Koch, MPH
Phone:
215-615-4312
Email:
Brittany.Koch@pennmedicine.upenn.edu
Contact backup:
Last name:
Kaitlin Kennard, BSN, RN
Phone:
267-804-4080
Email:
Kaitlin.Kennard@pennmedicine.upenn.edu
Start date:
October 15, 2024
Completion date:
October 15, 2026
Lead sponsor:
Agency:
Abramson Cancer Center at Penn Medicine
Agency class:
Other
Source:
Abramson Cancer Center at Penn Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06610344
