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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01109069 | Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia | PHASE2 | COMPLETED | 199 | — | — | Jun 1, 2010 | Apr 26, 2019 | May 27, 2020 | 16 | United States |
| NCT01292135 | Safety and Tolerability Study of PCI-32765 Combined With Fludarabine/Cyclophosphamide/Rituximab (FCR) and Bendamustine/Rituximab (BR) in Chronic Lymphocytic Leukemia (CLL) | PHASE1 | COMPLETED | 33 | — | — | Feb 1, 2011 | May 1, 2013 | Jul 24, 2014 | 6 | United States |
| NCT01217749 | Efficacy and Safety Study of PCI-32765 Combine With Ofatumumab in CLL | PHASE1 | COMPLETED | 71 | — | — | Dec 1, 2010 | May 1, 2014 | Jun 25, 2015 | 1 | United States |
| NCT01105247 | Safety of PCI-32765 in Chronic Lymphocytic Leukemia | PHASE1 | COMPLETED | 133 | — | — | May 1, 2010 | Feb 1, 2013 | Mar 31, 2014 | 10 | United States |
Subjects were to receive ibrutinib once daily at the dose level the subject was receiving in the parent study until disease progression or unacceptable toxicity. The study included Screening, Treatment (from the first dose until study drug discontinuation), and Follow-up Phases.
The primary endpoint for the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR), CR with incomplete blood count recovery (Cri), or partial response (PR), according to the guidelines from the International Workshop on Chronic Lymphocytic Leukemia (IWCLL1) published in 2008 for CLL participants and International Working Group for non-Hodgkin's lymphoma (IWG NHL) 2007 criteria for SLL participants, with the modification that treatment-related lymphocytosis will not be considered progressive disease, as evaluated by the investigators. Assessment of disease is based on radiological exams, physical exam, hematological evaluations and, when appropriate, bone marrow results.
Number of dose-limiting toxicities observed in the first 6 participants enrolled in treatment Groups 1 and 2
Number of participants who had experienced at least one treatment emergent AEs.
| Arm | Type | Description |
|---|---|---|
| PCI-32765 | EXPERIMENTAL | - |
| PCI-32765 plus fludarabine/cyclophosphamide/rituximab (FCR) | EXPERIMENTAL | - |
| PCI-32765 plus bendamustine/rituximab (BR) | EXPERIMENTAL | - |
| Group 1 | EXPERIMENTAL | In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing |
| Group 2 | EXPERIMENTAL | In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1) |
| Group 3 | EXPERIMENTAL | In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily |
| Name | Type | Description |
|---|---|---|
| PCI-32765 | DRUG | Dose based on parent protocol |
| ofatumumab | DRUG | per package insert as an IV infusion |
Inclusion Criteria: * Men and women with recurrent surface immunoglobulin positive B cell non-Hodgkin's lymphoma (NHL) according to WHO classification (including, but not limited to, CLL/SLL, Waldenström's macroglobulinemia \[WM\], mantle cell lymphoma \[MCL\], and diffuse large B cell lymphoma \[D...