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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02436707 | Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma | PHASE2 | ACTIVE NOT_RECRUITING | 129 | — | — | Oct 27, 2015 | Dec 31, 2026 | Apr 20, 2026 | 11 | Canada |
To determine the overall response rate (complete and partial response) to novel combination therapy in patients with relapsed and refractory aggressive B cell lymphoma
| Arm | Type | Description |
|---|---|---|
| R-GDP | ACTIVE_COMPARATOR | Rituximab - 375 mg/m2 IV, 1.5 - 6 hours D1 (prior to cisplatin); Gemcitabine - 1000 mg/m2, IV 30 min D1, D8; Dexamethasone - 40 mg daily PO D1 - D4; Cisplatin - 75 mg/m2 IV, 1 hour D1; |
| Ibrutinib plus R-GDP (ACCRUAL COMPLETE) | EXPERIMENTAL | Ibrutinib 560 mg PO -- D1 - D21 Rituximab 375 mg/m2 IV 1.5 - 6 hours D1 (prior to cisplatin) Gemcitabine 1000 mg/m2 IV 30 min D1, D8 Dexamethasone 40 mg daily PO -- D1 - D4 Cisplatin 75 mg/m2 IV 1 hour D1 |
| R-DICEP (ACCRUAL COMPLETE) | EXPERIMENTAL | Rituximab 375 mg/m2 IV 1.5-6hrs Day 1 and Day 5 prior to Cisplatin Mesna 1.75 g/m2 IV 24 hour Cycle 1, Day 2, Day 3 and Day 4 Cyclophosphamide, 1.75 g/m2 IV 2 hours, Day 2, Day 3 and Day 4 Etoposide 350 mg/m2 IV 2 hours, Day 2, Day 3 and Day 4 Cisplatin 35 mg/m2 IV, 2 hours, Day 2, Day 3 and Day 4 G-CSF 300 mcg (\<60kg); 480 mcg (60-90kg); 600 mcg (\>90kg); SC, Daily, starting Day 15 until apheresis completed. |
| Selinexor + R-GDP | EXPERIMENTAL | Selinexor - 40mg PO, D1, D3, D8 Rituximab - 375 mg/m2 IV, 1.5 - 6 hours D1 (prior to cisplatin); Gemcitabine - 1000 mg/m2, IV 30 min D1, D8; Dexamethasone - 40 mg daily PO D1 - D4; Cisplatin - 75 mg/m2 IV, 1 hour D1; |
| Name | Type | Description |
|---|---|---|
| Ibrutinib | DRUG | - |
| Rituximab | DRUG | - |
| Gemcitabine | DRUG | - |
| Dexamethasone | DRUG | - |
| Cisplatin | DRUG | - |
| Mesna | DRUG | - |
| Cyclophosphamide | DRUG | - |
| Etoposide | DRUG | - |
| G-CSF | DRUG | - |
| Selinexor | DRUG | - |
Inclusion Criteria: * Patients with histologic diagnosis for one of the following histologies according to the World Health Organization: documented at initial diagnosis or at relapse: * Diffuse large cell lymphoma, B-cell (includes primary mediastinal B-cell lymphoma, T-cell rich B-cell lymphom...