Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07082868

A Study of Epcoritamab and Ibrutinib in People With Central Nervous System Lymphoma (CNSL)

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-06

26

Participants Needed

8

Research Sites

154 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to find out whether the combination of epcoritamab and ibrutinib is a safe treatment approach that causes few or mild side effects in people with relapsed/refractory primary central nervous system lymphoma (PCNSL) or secondary central nervous system lymphoma (SCNSL).

CONDITIONS

Official Title

A Study of Epcoritamab and Ibrutinib in People With Central Nervous System Lymphoma (CNSL)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older at consent
  • Histologically confirmed diffuse large B-cell lymphoma (DLBCL) involving the central nervous system
  • ECOG performance status of 0, 1, or 2
  • Adequate bone marrow and organ function as defined by specific blood count and chemistry levels
  • Women of childbearing potential must use effective birth control during treatment and for 30 days after
  • Men must use effective contraception during treatment and for 3 months after
  • Negative pregnancy test for women of childbearing potential at screening
  • Ability to tolerate MRI or CT scans
  • Patients with impaired decision-making ability are eligible
Not Eligible

You will not qualify if you...

  • Newly diagnosed primary or secondary central nervous system lymphoma or non-CNS disease
  • Moderate to severe chronic liver impairment (Child-Pugh class B or C)
  • Concurrent use of other approved or investigational anti-cancer agents
  • Active concurrent malignancy requiring treatment
  • Recent chemotherapy, monoclonal antibodies, or targeted therapy within specified timeframes
  • Radiation therapy to CNS within 21 days prior to study drug
  • Requirement for more than 8 mg daily dexamethasone or equivalent
  • Use of warfarin or related anticoagulants within 7 days before study drug
  • Consumption of grapefruit, Seville oranges, or starfruit within 3 days prior to Cycle 1 Day 1
  • Use of drugs that strongly affect CYP3A enzyme within 5 half-lives or 2 weeks prior
  • Use of systemic immunosuppressants or prednisone >5 mg/day for over 12 months
  • Significant abnormal EKG or active serious cardiovascular disease
  • Ejection fraction below 50%
  • Known bleeding disorders
  • HIV infection
  • Active or chronic hepatitis B or C infection
  • Uncontrolled active systemic infection
  • Inability to swallow capsules or significant gastrointestinal issues
  • Life-threatening illness or organ dysfunction impacting safety
  • Recent live vaccinations within 28 days or expected during study
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

2

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

3

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States, 07645

Actively Recruiting

4

Memorial Sloan Kettering Commack (Limited Protocol Activities)

Commack, New York, United States, 11725

Actively Recruiting

5

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States, 10604

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

Actively Recruiting

7

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States, 11553

Actively Recruiting

8

University of Utah

Salt Lake City, Utah, United States, 84112

Actively Recruiting

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Research Team

C

Christian Grommes, MD

CONTACT

L

Lauren Schaff, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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