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

University of California, Irvine

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).

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

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 invol…

Interventions

Drug
Epcoritamab
Interventional Arm

Location

Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California
ucstudy@uci.edu 1-877-827-8839

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

Summary

Eligibility

Interventions

Location

Run this study?

Details

Conditions