Ketogenic Diet in Patients With Untreated Low Tumor Burden Mantle Cell Lymphoma (NCT04231734) | Clinical Trial Compass
WithdrawnNot Applicable
Ketogenic Diet in Patients With Untreated Low Tumor Burden Mantle Cell Lymphoma
Stopped: Low accrual
United States0Started 2023-04
Plain-language summary
This study evaluates adherence to a ketogenic diet in patients with low tumor burden, treatment-naïve mantle cell lymphoma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed diagnosis of mantle cell lymphoma
* Age ≥ 18 years
* No prior systemic therapy for lymphoma
* ECOG performance status ≤ 2
* Required initial laboratory parameters:
* Absolute neutrophil count (ANC) ≥ 1000 cells/mm3
* Platelet count ≥ 75,000 cells/mm3
* Calculated creatinine clearance ≥ 30 ml/min by Cockcroft-Gault formula
* Total bilirubin ≤ 2.0 x ULN
* AST/SGOT or ALT/SGPT ≤ 3.0 x ULN
* Understand and voluntarily sign an ICF prior to any study related assessments and procedures are conducted
Exclusion Criteria:
* Patients with blastoid histology
* Patients with known or suspected central nervous system (CNS) involvement
* Patients with a clear indication for treatment of lymphoma, including those with a tumor larger than 6 cm, more than 3 lymph nodes more than 3 cm, or constitutional symptoms
* Active viral infection with HIV or hepatitis type B or C. Seropositive HBV patients are eligible if they are negative for HBV DNA by PCR and receive concomitant antiviral therapy during treatment and for additional six months after coming off study.
* Active uncontrolled systemic fungal, bacterial or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment)
* Uncontrolled moderate to severe hypertriglyceridemia (TG\>300 mg/dL).
* Strong family history of hypertriglyceridemia and coronary artery disease.
* Myocardi…
What they're measuring
1
Number of subjects who adhere to ketogenic diet
Timeframe: 12 weeks
Trial details
NCT IDNCT04231734
SponsorWeill Medical College of Cornell University