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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04062448 | A Study of Ibrutinib in Combination With Rituximab, in Japanese Participants With Waldenstrom's Macroglobulinemia (WM) | PHASE2 | COMPLETED | 16 | — | — | Sep 25, 2019 | Mar 2, 2023 | May 25, 2025 | 9 | Japan |
| NCT03620903 | Efficacy of First Line B-RI for Treatment Naive Waldenström's Macroglobulinemia | PHASE2 | ACTIVE NOT_RECRUITING | 53 | — | — | Sep 11, 2019 | Feb 1, 2027 | Dec 5, 2025 | 12 | Germany, Greece |
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...