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

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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07819214

Enrollment

Registered

2026-09-14

Start date

2026-10-01

Completion date

2032-10-01

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BTKi, Chronic Lymphocytic Leukemia (CLL), CLL, CLL (Chronic Lymphocytic Leukemia)

Keywords

CLL, Chronic Lymphocytic Leukemia, BTKi, Bruton Tyrosine Kinase Inhibitor, Epcoritamab

Brief summary

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).

Interventions

DRUGEpcoritamab

Interventional Arm

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with CLL and at least 1 of the following risk factors: 1. ≥1 prior line of therapy before BTKi 2. 17p deletion and/or TP53 mutation 3. 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

Design outcomes

Primary

Measure	Time frame	Description
Rate of Undetectable Measurable Residual Disease (uMRD) at End of Treatment	1 year	Efficacy will be determined by rate of uMRD at EOT for both Epcoritamab and BTKi discontinuation

Secondary

Measure	Time frame	Description
Number of Participants with Complete Remission (CR) by International Workshop on CLL (iwCLL) criteria	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.

Countries

United States

Contacts

CONTACTChao Family Comprehensive Cancer Center University of California, Irvine

ucstudy@uci.edu1-877-827-8839

CONTACTUniversity of California Irvine Medical

PRINCIPAL_INVESTIGATORCatherine C Coombs, MD

Chao Family Comprehensive Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026