Clinical trial · Interventional
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
NCT07819214CI-TRIAL-00126292not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BTKi | — | UNRESOLVED | — |
| Chronic Lymphocytic Leukemia (CLL) | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| CLL | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| CLL (Chronic Lymphocytic Leukemia) | Chronic Lymphocytic Leukemia | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epcoritamab | Drug | Epcoritamab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Epcoritamab
- description
- Given IV
- interventionNames
- Drug: Epcoritamab
Primary outcomes (1)
- measure
- Rate of Undetectable Measurable Residual Disease (uMRD) at End of Treatment
- timeFrame
- 1 year
- description
- Efficacy will be determined by rate of uMRD at EOT for both Epcoritamab and BTKi discontinuation
Secondary outcomes (1)
- measure
- Number of Participants with Complete Remission (CR) by International Workshop on CLL (iwCLL) criteria
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.