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NCT Number: NCT07819214

Epcoritamab as Consolidation Therapy for High-Risk Pts w/CLL on BTKI

This is a phase 2, single-arm, open-label clinical trial determining efficacy of Epcoritamab in subjects with Chronic Lymphocytic Leukemia (CLL) on Burton Tyrosine Kinase Inhibitor (BTKi).

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Key information

Conditions

CLL BTKi CLL (Chronic Lymphocytic Leukemia) Chronic Disease Chronic Lymphocytic Leukemia (CLL) Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, 92868, United States

Location contact

Catherine C Coombs, MD

CONTACT

[email protected]

1-877-827-8839

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with CLL and at least 1 of the following risk factors:
  • ≥1 prior line of therapy before BTKi
  • 17p deletion and/or TP53 mutation
  • Complex karyotype (≥3 chromosomal abnormalities)
  • Treated with a BTKi for ≥ 6 months
  • Receiving or able to obtain a commercial supply of BTKi
  • Measurable residual disease defined as the presence of CLL cells by conventional flow cytometry
  • ALC ≤10 K/mcL
  • Lymph nodes ≤5 cm in the longest diameter
  • Normal organ function and hematologic parameters
  • ECOG performance status of 0-1

Exclusion criteria

  • Active CNS involvement
  • Active immune-mediated cytopenias
  • Current or prior Richter's transformation
  • Second active malignancy requiring treatment (excluding non-melanamatous skin cancers and cancers requiring hormonal therapies alone such as breast/prostate cancer)
  • Pregnant or breastfeeding

Treatment and study plan

Epcoritamab

Drug

Interventional Arm

Primary outcomes

  1. Rate of Undetectable Measurable Residual Disease (uMRD) at End of Treatment

    Time frame: 1 year

    Efficacy will be determined by rate of uMRD at EOT for both Epcoritamab and BTKi discontinuation

Secondary outcomes

  1. Number of Participants with Complete Remission (CR) by International Workshop on CLL (iwCLL) criteria

    Time frame: 1 year

    CR by iwCLL criteria is defined as meeting all parameters which include lymph nodes, liver and/or spleen size, constitutional systems, circulating lymphocyte count, platelet count, hemoglobin, and marrow.

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

[email protected]

1-877-827-8839

University of California Irvine Medical

CONTACT

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • Genmab

Registry information

Official study title

Epcoritamab as Consolidation Therapy for High-risk Patients With Chronic Lymphocytic Leukemia on Bruton Tyrosine Kinase Inhibitor

Important dates

Study start
2026
Primary completion
2028
Study completion
2032
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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