Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07738887 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 5 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Chronic Lymphocytic Leukemia is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07738887 is notable because it evaluates Ibrutinib in a Phase 2 design sponsored by Le LYSARC. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
| Field | Indexed detail |
|---|---|
| Registration | NCT07738887 |
| Official title | Epcoritamab Plus Venetoclax Plus Ibrutinib in Patients With Chronic Lymphocytic Leukemia With TP53 Alterations (EVITA) |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | Ibrutinib |
| Sponsor | Le LYSARC |
| Geography | Belgium, France |
| Enrollment | [object Object] |
| Primary endpoint | Rate of Participants Achieving Complete Remission (CR) with Undetectable Minimal Residual Disease (uMRD) in Bone Marrow |
| Endpoint time frame | 18 months |
| Primary completion / readout proxy | [object Object] |
This is a phase 2, open-label, multicenter study evaluating the efficacy and safety of a fixed-duration combination of epcoritamab, venetoclax, and ibrutinib (EVI) in previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have TP53 alterations. Patients with TP53 abnormalities, including TP53 mutation and/or 17p deletion, have a poorer prognosis and are less likely to benefit from conventional chemoimmunotherapy. Targeted therapies such as ibrutinib and venetoclax have improved outcomes in this population, but many patients eventually experience disease progression. This study investigates whether adding epcoritamab, a CD3×CD20 bispecific antibody, to the combination of ibrutinib and venetoclax can improve the depth and durability of treatment responses while using a fixed-duration treatment approach. Participants will receive sequential treatment with ibrutinib alone, followed by i
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of [object Object] participants across Belgium, France shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Drug & Asset MCP profile: Ibrutinib is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: Le LYSARC is resolved to a normalized organization record in France. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
NCT07738887 provides a focused lens on Chronic Lymphocytic Leukemia development. Its value will be determined by whether Ibrutinib can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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