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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01578707 | A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia | PHASE3 | COMPLETED | 391 | — | — | Jun 1, 2012 | Oct 25, 2018 | Dec 18, 2019 | 76 | United States, Australia +8 |
The primary objective of this study was to evaluate the efficacy of ibrutinib compared to ofatumumab based on independent review committee (IRC) assessment of progression-free survival (PFS) according to 2008 IWCLL guidelines.
| Arm | Type | Description |
|---|---|---|
| Ofatumumab (Arm A) | ACTIVE_COMPARATOR | An anti-CD20 monoclonal antibody |
| ibrutinib (Arm B) | EXPERIMENTAL | A Bruton Tyrosine Kinase Inhibitor |
| Name | Type | Description |
|---|---|---|
| ofatumumab | DRUG | The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks) |
| ibrutinib | DRUG | ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity |
Inclusion Criteria: * ECOG performance status of 0-1. * Diagnosis of CLL or SLL that meets IWCLL 2008 criteria. * Active disease meeting at least 1 of the IWCLL 2008 criteria for requiring treatment. * Must have received at least one prior therapy for CLL/SLL. * Considered not appropriate for treat...