RECRUITING

Tazemetostat and Venetoclax in Relapsed/Refractory Non-Hodgkin Lymphoma

Conditions

Lymphoma, Non-Hodgkin Diffuse Large B Cell Lymphoma Follicular Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-06-07

Study Completion:2028-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05618366

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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

Inclusion Criteria

Exclusion Criteria

* 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

Contacts and Locations

Study Contact

Tejasvi Kaur Sahni

CONTACT

646-962-8189

tks4001@med.cornell.edu

Brittany Hobbie

CONTACT

brh4008@med.cornell.edu

Principal Investigator

Lisa Roth, M.D.

PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine/NewYork-Presberteryian Hospital

New York, New York, 10021

United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

Lisa Roth, M.D., PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-07

Study Completion Date2028-12

Study Record Updates

Study Start Date2023-06-07

Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

Lymphoma, Non-Hodgkin
Diffuse Large B Cell Lymphoma
Follicular Lymphoma