Non Hodgkin Lymphoma Clinical Trial
Tazemetostat and Venetoclax in Relapsed/Refractory Non-Hodgkin Lymphoma
The goal of this clinical trial is to learn about how a combination of tazemetostat and venetoclax in people with relapsed/refractory Non-Hodgkin Lymphoma (R/R NHL). The main questions that this trial aims to answer are what is the best dose of venetoclax to give with tazemetostat to people with R/R NHL; what types of side effects do people with R/R NHL get when taking venetoclax with tazemetostat; and what effects does this combination have on R/R NHL. Participants will need to take pills by mouth every day and regularly come to the clinic for blood work and imagining to monitor side effects and cancer progression. Participants may receive study drugs for up to 24 months.
This a phase 1, single arm, non-randomized trial of tazemetostat in combination with venetoclax in participants with two types of relapsed/refractory non-Hodgkin lymphoma. The purpose of this study is to evaluate the safety of the combination of tazemetostat and venetoclax in patients with relapsed/refractory (R/R) Follicular Lymphoma (FL) and Diffuse Large B-cell Lymphoma (DLBCL). This trial will be conducted in two parts. Part one will be a single-arm, open-label sequential dose escalation (3+3) of venetoclax in combination with a fixed dose of tazemetostat (800mg BID) to determine the maximum tolerated dose (MTD) of venetoclax. In part two, two expansion cohorts (R/R DLBCL and R/R FL) will be enrolled to further characterize the safety and tolerability of the combination, and to estimate the preliminary efficacy. Up to 18 participants will be enrolled in part 1 and 20 participants will be enrolled in part 2.
Histologically confirmed, biopsy-proven diagnosis of FL or DLBCL.
Subjects must have been treated with at least one prior line of therapy for lymphoma with evidence of disease progression.
Subjects are eligible if they have progressed after ASCT OR if they are ineligible for ASCT
Significant cardiovascular impairment, such as history of congestive heart failure, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug
Known hypersensitivity to any of the study drugs
History of other cancer (some exceptions apply)
Known CNS (brain or spinal cord) involvement at diagnosis
Richter's transformation from CLL
Evidence of uncontrolled systemic infection (viral, bacterial, or fungal)
Major surgery within 3 weeks prior to the start of study treatment
Venous thrombosis or pulmonary embolism within the last 3 months before starting study
Uncontrolled infection with human immunodeficiency virus (HIV) or human T-cell leukemia virus 1
Pregnant or lactating (people capable of becoming pregnant or getting someone else pregnant must be willing to use highly effective birth control)
Malabsorption syndrome or other condition that precludes enteral route of administration
Inability to swallow tablets
Known allergy to both xanthine oxidase inhibitors and rasburicase
Clinically significant history of liver disease, including but not limited to viral or other hepatitis, current alcohol abuse, or cirrhosis
Active hepatitis C (defined as a positive HCV viral load)
Chronic use of moderate or strong CYP3A4 modulators (inhibitor or inducer); chronic use of a P-gp inhibitor, or a P-gp substrate with a narrow therapeutic index; or use of certain other prohibited medications
Prior exposure to either tazemetostat or venetoclax
Prior history of T-LBL/T-ALL
Previous solid organ transplant
Requires the use of warfarin (because of potential drug-drug interactions that may potentially increase the exposure of warfarin)
Vaccination with live vaccines within 28 days prior to treatment
Consumed grapefruit or grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of study drug
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