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

University of California Irvine (UCI)

Status and phase: Begins enrollment this month; Phase 2

Conditions: CLL; CLL (Chronic Lymphocytic Leukemia); Chronic Lymphocytic Leukemia (CLL); BTKi

Treatments: Drug: Epcoritamab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07819214

UCI 24-32 (Other Identifier)

STUDY00000092

Details and patient eligibility

About

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).

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Epcoritamab

Experimental group

Description:

Given IV

Treatment:

Drug: Epcoritamab