Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ofatumumab · 1 trial · 2 indications
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...
Ofatumumab is an investigational drug being studied for the treatment of relapsed or refractory chronic lymphocytic leukemia. It is being evaluated in a Phase 3 clinical trial for this indication. The drug is also being studied in patients with small lymphocytic lymphoma, a related condition.
Ofatumumab is a small molecule therapy being developed for oncology. Its specific molecular target has not been disclosed in the available information. The drug is being studied in patients with relapsed or refractory chronic lymphocytic leukemia, where it is compared against another treatment in a Phase 3 trial.
Ofatumumab is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting a Phase 3 clinical trial of ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia.
Ofatumumab is in Phase 3 clinical development for relapsed or refractory chronic lymphocytic leukemia. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 3 trial has been completed, with a total enrollment of 391 patients.
Ofatumumab is being studied in a Phase 3 clinical trial with the identifier NCT01578707. This trial is titled 'A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia' and has been completed. The trial enrolled 391 patients across multiple countries.
No, ofatumumab is not the same as ibrutinib. In the Phase 3 clinical trial NCT01578707, ofatumumab is being compared directly against ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia. The trial is active-controlled, meaning ibrutinib serves as the comparator treatment.