Ketogenic Diet in Patients With Untreated Low Tumor Burden Mantle Cell Lymphoma

NCT04231734 | Withdrawn DMC

• 1 other identifier: 19-05020213
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates adherence to a ketogenic diet in patients with low tumor burden, treatment-naïve mantle cell lymphoma.

Conditions

Mantle Cell Lymphoma; Ketogenic Dieting

Outcome Measures

Primary Outcomes (1)

• Number of subjects who adhere to ketogenic diet

  Number of subjects who adhere to ketogenic diet as defined by serum betahydroxybutyrate \> 1.0 mM at 7 out of 11 timepoints

  12 weeks

Secondary Outcomes (12)

• Number of subjects who achieve a partial or complete response

  12 weeks

• Number of subjects who exhibit a significant change in fasting serum metabolic markers

  Baseline, 16 weeks

• Number of subjects who exhibit a significant change in serum mediators of inflammation

  Baseline, 16 weeks

• Number of subjects who exhibit a significant change in blood cell populations

  Baseline, 16 weeks

• Change in body composition as measured by difference in ideal body weight and actual body weight at the end of study compared to baseline

  Baseline, 16 weeks

Study Arms (1)

All Subjects

EXPERIMENTAL

Low tumor burden, treatment-naïve MCL

Other: Ketogenic Diet

Interventions

Ketogenic Diet OTHER

Prepared ketogenic meals, 3 per day for up to 12 weeks (Day 1 through Day 84)

All Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Myocardial infarction within 6 months of cycle 1, day 1. \[Subjects with a history of myocardial infarction between 6 and 12 months prior to cycle 1, day 1, who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event, may participate\].
• Symptomatic coronary artery disease (CAD), e.g., angina Canadian Class II-IV. In any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present.
• An ECG recorded at screening showing evidence of cardiac ischemia (ST depression of ≥ 2 mm, measured from isoelectric line to the ST segment). If in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present.
• Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV definitions and/or ejection fraction \< 40% by multigated acquisition (MUGA) scan or \< 50% by echocardiogram and/or magnetic resonance imaging (MRI).
• Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before the start of study medication.
• Patients requiring dual anti-platelets treatment for cardiac conditions or patients who are on anticoagulation for arterial or venous thrombosis.
• Patients with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Type I diabetes

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Related Links

• WCM Joint Clinical Trials Office

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Peter Martin, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 18, 2020
• Study Start: April 1, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)