Epcoritamab as Consolidation Therapy for High-Risk Pts w/CLL on BTKI
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Irvine
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
≥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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Epcoritamab
DrugInterventional Arm
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: EpcoritamabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of Undetectable Measurable Residual Disease (uMRD) at End of Treatment
Efficacy will be determined by rate of uMRD at EOT for both Epcoritamab and BTKi discontinuation
Time frame
1 yearSecondary outcomes
1
Number of Participants with Complete Remission (CR) by International Workshop on CLL (iwCLL) criteria
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.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Irvine
Lead sponsor
Genmab
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: