Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06563596 | Epco, Zanu, Ritux for R/R FL or MZL | PHASE2 | RECRUITING | 45 | — | — | Jan 21, 2025 | Mar 1, 2030 | Feb 19, 2026 | 3 | United States |
CMR rate is defined as the proportion of participants who achieved CMR during study. CMR assessed by PET/CT is defined using Lugano criteria.
CMR rate is defined as the proportion of participants who achieved CMR during study. CMR assessed by PET/CT or CT is defined using Lugano criteria.
| Arm | Type | Description |
|---|---|---|
| Rituxan + Zanubrutinib + Epcoritamab for FL | EXPERIMENTAL | Enrolled participants will complete: * Baseline visit with imaging and bone marrow biopsy * Imaging on cycles 3, 6, 9 * Up to 1 year of treatment with study drugs * End of Treatment visit with imaging and bone marrow biopsy * Follow up visits every 6 months for up to 10 years |
| Rituxan + Zanubrutinib + Epcoritamab for MZL | EXPERIMENTAL | Enrolled participants will complete: * Baseline visit with imaging and bone marrow biopsy * Imaging on cycles 3, 6, 9 * Up to 1 year of treatment with study drugs * End of Treatment visit with imaging and bone marrow biopsy * Follow up visits every 6 months for up to 10 years |
| Name | Type | Description |
|---|---|---|
| Zanubrutinib | DRUG | Bruton tyrosine kinase inhibitor, 80 mg immediate-release capsule, taken orally per protocol. |
| Rituximab | DRUG | Chimeric anti-CD20 monoclonal antibody, 10 or 50 mL single-use vials, via intravenous infusion per institutional standard. |
| Epcoritamab | DRUG | Bispecific antibody, 5 or 60 mg/mL vials, via subcutaneous (under the skin) injection per protocol. |
Inclusion Criteria: * Histologically confirmed diagnosis of CD20+ FL (grade 1-3A) or CD20+ MZL (any subtype) (at time of trial entry) with review of the diagnostic pathology specimen at one of the participating institutions. Patients with current histologic transformation are excluded. * Receipt of...