Tazemetostat and Venetoclax in Relapsed/Refractory Non-Hodgkin Lymphoma

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT05618366
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Participants will receive oral venetoclax taken once per day. The dose will be between 200 and 800 mg daily, with the exact dose determined by the protocol.
  • Tazemetostat — DRUG
    Tazemetostat 800mg taken orally, twice daily.

Study Details

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.

Key Dates

Start date
Jun 7, 2023
Status verified
Mar 2026
Primary completion
Feb 27, 2026
Completion
Feb 27, 2026

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Maximum-tolerated dose (MTD) determination (Part 1) [ Time Frame: Day 0 to 28 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell Medicine/NewYork-Presberteryian HospitalNew YorkNew York10021-

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By research site
Weill Cornell Medicine/NewYork-Presberteryian Hospital· New York, NY

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