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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01974440 | A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Participants With Previously Treated Indolent Non-Hodgkin Lymphoma | PHASE3 | COMPLETED | 403 | — | — | Jan 31, 2014 | Jun 21, 2023 | May 25, 2025 | 135 | United States, Argentina +17 |
| NCT01779791 | A Study of PCI-32765 (Ibrutinib) in Patients With Refractory Follicular Lymphoma | PHASE2 | COMPLETED | 110 | — | — | Apr 17, 2013 | May 18, 2016 | Jul 18, 2017 | 54 | United States, Australia +7 |
PFS was defined as duration (in months) from the date of randomization to the date of disease progression or relapse from complete response (CR) or death, whichever was first reported. PFS was assessed by the investigator based on the 2007 Revised Response Criteria for Malignant Lymphoma. Disease progression was defined as any new lesion or increase by greater than or equal to (\>=) 50 percent (%) of previously involved sites from nadir disease progression criteria: Appearance of new nodal lesion 1.5 centimeters (cm) in any axis, 50% increase in sum of product of diameters (SPD) of greater than (\>) 1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis.
PFS in MZL participants was defined as duration (in months) from the date of randomization to the date of disease progression or relapse from CR or death, whichever was first reported. PFS was assessed by the investigator based on the 2007 Revised Response Criteria for Malignant Lymphoma. Disease progression was defined as any new lesion or increase by \>=50% of previously involved sites from nadir disease progression criteria: Appearance of new nodal lesion 1.5 cm in any axis, 50% increase in SPD of \>1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm A | PLACEBO_COMPARATOR | Treatment Arm A = background immune-chemotherapy (bendamustine and rituximab \[BR\] or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone \[R-CHOP\]) for 6 cycles + placebo. |
| Treatment Arm B | EXPERIMENTAL | Treatment Arm B = background immune-chemotherapy (BR or R-CHOP) for 6 cycles + PCI-32765 (Ibrutinib). |
| PCI-32765 (Ibrutinib) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Bendamustine | DRUG | 90 milligram per meter square (mg/m\^2) administered intravenously on Days 1 to 2 of Cycles 1 to 6. |
| Rituximab | DRUG | 375 mg/m\^2 administered intravenously on Day 1 of Cycles 1 to 6. |
| Cyclophosphamide | DRUG | 750 mg/m\^2 administered intravenously on Day 1 of Cycles 1 to 6. |
| Doxorubicin | DRUG | 50 mg/m\^2 administered intravenously on Day 1 of Cycles 1 to 6. |
| Vincristine | DRUG | 1.4 mg/m\^2 (maximum total 2 mg) administered intravenously on Day 1 of Cycles 1 to 6. |
| Prednisone | DRUG | 100 mg administered orally on Days 1 to 5 of Cycles 1 to 6. |
| PCI-32765 (Ibrutinib) | DRUG | 560 mg (4\*140 mg) capsules administered orally once daily, continuously starting on Cycle 1, Day 1. |
| Placebo | DRUG | Placebo (4 capsules) matched to ibrutinib administered orally once daily, continuously starting on Cycle 1, Day 1. |
Inclusion Criteria: * Histologically confirmed diagnosis of B-cell indolent Non-Hodgkin lymphoma with histological subtype limited to follicular lymphoma or marginal zone lymphoma, at initial diagnosis and without evidence of pathological transformation or clinical signs suggesting transformation *...