This study is not yet accepting patients

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

a study on Chronic Lymphocytic Leukemia Leukemia BTKi

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California
Dates
study started
study ends around
Principal Investigator
by Catherine Coombs

Description

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).

Official Title

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

Keywords

CLL, CLL (Chronic Lymphocytic Leukemia), Chronic Lymphocytic Leukemia (CLL), BTKi, Chronic Lymphocytic Leukemia, Bruton Tyrosine Kinase Inhibitor, Epcoritamab, B-Cell Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Location

  • Chao Family Comprehensive Cancer Center, University of California, Irvine
    Orange California 92868 United States

Lead Scientist at UC Irvine

  • Catherine Coombs
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 88 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT07819214
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 24 study participants
Last Updated