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Not yet recruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well epcoritamab works in people with chronic lymphocytic leukemia (CLL), a type of blood cancer. It is for people with higher-risk CLL who have taken a BTK inhibitor (BTKi), a cancer medicine, for at least 6 months.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have CLL and at least one risk factor: treatment before BTKi, a 17p deletion or TP53 mutation (gene changes), or at least 3 chromosome changes.
  • Have taken a BTKi for at least 6 months.
  • Are getting or can get a commercial supply of BTKi medicine.
  • Still have CLL cells found by flow cytometry, a test that checks cells.
  • Have a lymphocyte count (a type of white blood cell) of 10,000 per microliter or less.
  • Have no lymph node larger than 5 cm across.
  • Have normal organ function and blood test results.
  • Can do daily activities with no limits or only limits on hard physical activity.

Who can't join

  • Have active CLL in the brain or spinal cord.
  • Have an active condition where the immune system causes low blood cell counts.
  • Have or have had Richter's transformation, when CLL changes into a faster-growing cancer.
  • Have another active cancer that needs treatment, except non-melanoma skin cancer or cancer needing only hormone treatment, such as some breast or prostate cancers.
  • Are pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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 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

Study sites (1)

CA