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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ Patients must meet the following criteria for study entry:

• Adults aged ≥18

• Require therapy as determined by the treating physician

• 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

• ECOG PS 0-2

• Ability and willingness to provide signed Informed Consent Form

• Ability and willingness to comply with the requirements of the study protocol

• Measurable disease (defined as ≥ 1.5cm in diameter) In addition, patients must meet the following conditions for enrollment based on whether they have DLBCL or FL.

∙ R/R DLBCL Cohort:

• Histologically confirmed, biopsy-proven diagnosis of DLBCL (as determined by WHO standard classification criteria).

• Please note: Transformed DLBCL patients are eligible, with the exception of Richter's transformation.

• Subjects must have received at least two prior lines 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, as determined by their treating physician.

∙ R/R FL Cohort:

• Histologically confirmed, biopsy-proven diagnosis of FL

• Subjects are eligible if they have progressed after two or more lines of therapy for lymphoma or have no satisfactory treatment alternatives

Locations
United States
New York
Weill Cornell Medicine/NewYork-Presberteryian Hospital
RECRUITING
New York
Contact Information
Primary
Tejasvi Kaur Sahni
tks4001@med.cornell.edu
646-962-8189
Backup
Brittany Hobbie
brh4008@med.cornell.edu
Time Frame
Start Date: 2023-06-07
Estimated Completion Date: 2028-12
Participants
Target number of participants: 38
Treatments
Experimental: Tazemetostat and Venetoclax
All participants will receive a combination of oral 800 mg tazemetostat BID and oral venetoclax. Since this is a phase 1 trial, the dose of venetoclax will be determined by the investigators per a sequential dose escalation (3+3). Participants will be provided study drug in the form of pills to take at home. Study participants will need to regularly come to the clinic for blood work, imaging, and to monitor and side effects. Participants may receive study drug until their cancer progresses or for up to 24 months.
Sponsors
Collaborators: Genentech, Inc., Epizyme, Inc.
Leads: Weill Medical College of Cornell University

This content was sourced from clinicaltrials.gov