Approval Probability
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Adjusted LOA
ML Risk
Ibrutinib · 1 trial · 1 indication
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...
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Ibrutinib is an investigational small molecule being studied for the treatment of lymphoma, specifically in a Phase 2 clinical trial for relapsed and refractory aggressive B-cell lymphoma. It is being developed by Karyopharm Therapeutics Inc. and is not yet approved by the FDA.
Ibrutinib is a kinase inhibitor, as indicated by its '-tinib' suffix, which denotes a class of drugs that target kinases. Kinases are enzymes involved in cell signaling and growth, and inhibiting them can help slow or stop cancer cell proliferation.
Ibrutinib is being developed by Karyopharm Therapeutics Inc., a biopharmaceutical company traded under the ticker symbol KPTI. The company is conducting clinical research on this drug for the treatment of lymphoma.
Ibrutinib is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy in patients with lymphoma.
Ibrutinib is being studied in a single Phase 2 clinical trial with the identifier NCT02436707, titled 'Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma.' This active, non-recruiting trial is enrolling 129 participants in Canada and is open to individuals aged 16 years and older.
Yes, Ibrutinib is the same as ibrutinib. The drug is commonly referred to by its generic name, ibrutinib, and is being developed by Karyopharm Therapeutics Inc. for the treatment of lymphoma.