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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06230224 | A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma | PHASE3 | ACTIVE NOT_RECRUITING | 216 | — | — | Feb 15, 2024 | May 29, 2029 | May 11, 2026 | 81 | Argentina, Australia +12 |
| NCT03888105 | A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previously Treated With Other Cancer Therapies | PHASE2 | ACTIVE NOT_RECRUITING | 515 | — | — | Nov 13, 2019 | Dec 15, 2028 | Oct 15, 2025 | 119 | United States, Australia +12 |
FL grade 1-3a/MZL
DLBCL/MCL/Other B-NHL
| Arm | Type | Description |
|---|---|---|
| Odronextamab | EXPERIMENTAL | Participants will receive odronextamab monotherapy. |
| Standard Of Care | ACTIVE_COMPARATOR | Participants will receive salvage therapy (ifosfamide, carboplatin, etoposide ± rituximab \[ICE ± R\], or dexamethasone, cisplatin, cytarabine ± rituximab \[DHAP ± R\], or gemcitabine, dexamethasone, cisplatin ± rituximab \[GDP ± R\]) and continue with autologous stem cell transplant (ASCT) following a complete response (CR)/partial response (PR). |
| FL | EXPERIMENTAL | Follicular lymphoma grade 1-3a cohort |
| DLBCL | EXPERIMENTAL | Diffuse large B-cell lymphoma cohort |
| MCL | EXPERIMENTAL | Mantle Cell Lymphoma cohort |
| MZL | EXPERIMENTAL | Marginal Zone Lymphoma cohort |
| Other B-NHL | EXPERIMENTAL | Other B-cell non-Hodgkin lymphoma cohort (excluding FL Grade 1-3a, DLBCL, MCL, MZL, Waldenström macroglobulinemia \[WM\]); Patients with a current diagnosis of mixed histology of B-NHL with an aggressive component (such as concurrent FL and DLBCL) will be allowed |
| Name | Type | Description |
|---|---|---|
| Odronextamab | DRUG | Administered by intravenous (IV) infusion |
| Ifosfamide | DRUG | Administered by IV infusion, as part of the ICE ± R salvage therapy |
| Carboplatin | DRUG | Administered by IV infusion, as part of the ICE ± R salvage therapy |
| Etoposide | DRUG | Administered by IV infusion, as part of the ICE ± R salvage therapy |
| Rituximab | DRUG | Administered by IV infusion, as part of the ICE ± R, or DHAP ± R, or GDP ± R salvage therapy. |
| Dexamethasone | DRUG | Administered by IV, or orally (PO) as part of the DHAP ± R, or GDP ± R salvage therapy. |
| Cisplatin | DRUG | Administered by IV infusion, as part of the DHAP ± R or GDP +/-R salvage therapy. |
| Cytarabine | DRUG | Administered by IV infusion, as part of the DHAP ± R salvage therapy. |
| Gemcitabine | DRUG | Administered by IV infusion, as part of the GDP ± R salvage therapy. |
Key Inclusion Criteria: 1. Histologically proven aggressive B-NHL, as described in the protocol. Availability of tumor tissue for submission to central laboratory is required for study enrollment. Archival tumor tissue for histological assessment prior to enrollment is allowed 2. Have primary refra...