Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Ibrutinib, Ibrutinib Oral Tablet
Ibrutinib/ Bortezomib/ Rituximab · 2 trials · 1 indication
ORR is defined as the percentage of participants achieving a best overall response of confirmed complete response (CR), very good partial response (VGPR) or partial response (PR) according to the modified sixth IWWM criteria (National Comprehensive Cancer Network \[NCCN\] version 2, 2019), as assessed by the Independent Review Committee (IRC). CR: Immunoglobulin M (IgM) in normal range, disappearance of monoclonal protein by immunofixation, no histologic evidence of bone marrow involvement, resolution of any adenopathy/organomegaly (if present at baseline) along with no signs or symptoms attributable to Waldenstrom's Macroglobulinemia (WM); VGPR and PR: greater than or equal to (\>=) 90 percent (%) (for VGPR) and \>=50% (for PR) reduction of serum IgM, decrease in adenopathy/organomegaly (if present at baseline) on physical examination or computerized tomography (CT) scan, no new symptoms or signs of active disease.
The primary endpoint is the rate of 1 year progression free survival (1YPFS).
| Arm | Type | Description |
|---|---|---|
| Ibrutinib + Rituximab | EXPERIMENTAL | Participants will receive ibrutinib 420 milligram (mg) orally, once daily, from Day 1 of Week 1 until disease progression or unacceptable toxicity in combination with rituximab 375 milligram per square meter (mg/m\^2) intravenously (IV) on Day 1 of Weeks 1 to 4 and Weeks 17 to 20. |
| Bortezomib-Rituximab-Ibrutinib | EXPERIMENTAL | Cycle 1: Rituximab: 375 mg/m2 intravenously (i.v) day 1; Bortezomib:1.6 mg/ m2 subcutanously (SC) day 1,8,15; Ibrutinib: 420 mg orally (p.o.) day 1-28; Cycle 2-6 Rituximab: 1400 mg absolute SC day 1; Bortezomib:1.6 mg/ m2 SC day 1,8,15; Ibrutinib: 420 mg p.o. day 1-28; Maintenance I (1 cycle = 56 days): Ibrutinib 420 mg p.o. daily, until evidence of progressive disease or no longer tolerated by the subject (for a maximum of 10 years); Rituximab 1400 mg absolute SC day 1, every second month for 24 months (month 7-30); Maintenance II (1 cycle = 84 days): Ibrutinib 420 mg p.o. daily, until evidence of progressive disease or no longer tolerated by the subject (for a maximum of 10 years); |
| Name | Type | Description |
|---|---|---|
| Ibrutinib | DRUG | Ibrutinib 420 mg will be administered orally. |
| Rituximab | DRUG | Rituximab 375 mg/m\^2 will be administered intravenously. |
| Ibrutinib / Bortezomib / Rituximab | DRUG | Induction (Rituximab / Bortezomib / Ibrutinib), Maintenance I (Ibrutinib / Rituximab), Maintenance II (Ibrutinib) |
Inclusion Criteria: * Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia (WM) in accordance with the consensus panel of the second International Workshop on Waldenstrom's Macroglobulinemia (IWWM) * Japanese participants with treatment naïve or relapsed/refractory WM * Measurable disea...
Ibrutinib is an investigational small molecule being studied for use in DLBCL, lymphocytic leukemia, graft vs host disease, chronic lymphocytic leukemia, B-cell lymphoma, and mantle cell lymphoma. It is currently in Phase 1 clinical development.
Ibrutinib is a Bruton's tyrosine kinase (BTK) inhibitor. It is being studied in oncology for conditions including DLBCL, lymphocytic leukemia, graft vs host disease, chronic lymphocytic leukemia, B-cell lymphoma, and mantle cell lymphoma.
Ibrutinib is being developed by Johnson & Johnson, which trades under the ticker JNJ. The drug is currently in Phase 1 clinical trials for multiple oncology indications.
Ibrutinib is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. It is being studied for DLBCL, lymphocytic leukemia, graft vs host disease, chronic lymphocytic leukemia, B-cell lymphoma, and mantle cell lymphoma.
Ibrutinib has completed several Phase 1 trials, including NCT02390609, NCT02556892, NCT02638116, and NCT02877225. These studies evaluated bioavailability, drug interactions, and bioequivalence in healthy adults and patients with lymphocytic leukemia.
Ibrutinib is also known as Ibrutinib Oral Tablet and Ibrutinib / Bortezomib / Rituximab. These names refer to the same drug or combination being studied in clinical trials.