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Tazemetostat and Venetoclax in Relapsed/Refractory Non-Hodgkin Lymphoma | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Tazemetostat and Venetoclax in Relapsed/Refractory Non-Hodgkin Lymphoma

Phase I Trial of Tazemetostat in Combination With Venetoclax in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma

NCT05618366•Weill Medical College of Cornell University

Summary

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.

Detailed Description

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. 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) we will conduct a phase I trial in two parts. In part one, we will perform a single-arm, open-label sequential dose escalation (3+3) of venetoclax in combination with tazemetostat, given at its recommended phase II dose (RP2D) of 800mg BID, to determine the maximum tolerated dose (MTD) of venetoclax. In part two, we will enroll two expansion cohorts (R/R DLBCL and R/R FL) 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must meet the following criteria for study entry:
•1. Adults aged ≥18
•2. Require therapy as determined by the treating physician
•3. Patients must have adequate organ and bone marrow function:
•* Absolute neutrophil count (ANC) ≥ 1 x 109/L without growth factor support (filgrastim or pegfilgrastim) for at least 14 days
•* Platelet count ≥75 x 109/L, evaluated at least 7 days after last platelet transfusion
•* Hemoglobin ≥9.0g/dL, independent of transfusion
•* Total bilirubin \< 1.5 x's the upper limit of the normal range (ULN), except Gilbert's disease
•* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 3 x's ULN.
•* Calculated creatinine clearance according to the Cockcroft-Gault equation. ≥ 40 mL/min
+10 more criteria

Exclusion Criteria

•Patients who meet any of the following criteria will be excluded from study entry:
•1. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug; or cardiac ventricular arrhythmia.
•2. Known hypersensitivity to any of the study drugs
•3. History of other malignancy that could affect compliance with the protocol or interpretation of results
•a. Patients with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are generally eligible. Patients with a malignancy that has been treated, but not with curative intent, will also be excluded, unless the malignancy has been in remission without treatment for 2 years prior to enrollment.
•4. Known CNS involvement at diagnosis (CNS evaluation not required in the absence of clinical suspicion)
•5. Richter's transformation from CLL
•6. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to, uncontrolled systemic infection (viral, bacterial, or fungal).
•7. Major surgery within 3 weeks prior to the start of study treatment
•8. Venous thrombosis or pulmonary embolism within the last 3 months before starting study; whereas subjects greater than 3 months since deep vein thrombosis/pulmonary embolism are eligible but are recommended to receive prophylaxis.
+17 more criteria

Locations (1)

Weill Cornell Medicine/NewYork-Presberteryian Hospital

New York, New York, United States

Key Dates

Start Date

June 7, 2023

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2028

Last Updated

April 8, 2025

Enrollment

ESTIMATED participants

Conditions

Lymphoma, Non-HodgkinDiffuse Large B Cell LymphomaFollicular Lymphoma

Interventions

Venetoclax

DRUG

Tazemetostat

DRUG

Contacts

Tejasvi Kaur Sahni

CONTACT

646-962-8189 tks4001@med.cornell.edu

Brittany Hobbie

CONTACT

brh4008@med.cornell.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Tazemetostat and Venetoclax in Relapsed/Refractory Non-Hodgkin Lymphoma

Inclusion Criteria

Exclusion Criteria

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