A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy results in a clinically significant improvement in progression free survival (PFS) as compared to treatment with ofatumumab in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Dec 18, 2019 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Pharmacyclics LLC.
- Interventions being studied
- Drug: ofatumumab; Drug: ibrutinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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 treatment or retreatment with purine analog based therapy.
- Measurable nodal disease by CT.
- Patients must be able to receive outpatient treatment and laboratory monitoring at the institution that administers study drug for the entire study.
- Known CNS lymphoma or leukemia.
- No documentation of cytogenetic and/or FISH in patient records prior to first dose of study drug.
- Any history of Richter's transformation or prolymphocytic leukemia.
- Uncontrolled Autoimmune Hemolytic Anemia (AIHA) or idiopathic thrombocytopenia purpura (ITP).
- Prior exposure to ofatumumab or to ibrutinib.
- Prior autologous transplant within 6 months prior to first dose of study drug.
- Prior allogeneic stem cell transplant within 6 months or with any evidence of active graft versus host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug.
- History of prior malignancy, with the exception of certain skin cancers and malignancies treated with curative intent and with no evidence of active disease for more than 3 years.
- Serologic status reflecting active hepatitis B or C infection.
- Unable to swallow capsules or disease significantly affecting gastrointestinal function.
- Uncontrolled active systemic fungal, bacterial, viral, or other infection.
- History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug.
- Requires anticoagulation with warfarin.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Site #408La Jolla, California
- Site #377Los Angeles, California
- Site #403Santa Maria, California
- Site #038Stanford, California
- Site #411Norwalk, Connecticut
- Site #107Marietta, Georgia
- Site # 379Evansville, Indiana
- Site # 390Boston, Massachusetts
- Site # 391Boston, Massachusetts
- Site # 349Boston, Massachusetts
- Site # 130Detroit, Michigan
- Site # 406Rochester, Minnesota
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 18, 2019. Always confirm current availability with the study team.