A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Status: Recruiting
Phase: Phase 3
Diagnosis: Leukemia/MDS
NCT ID: NCT01578707 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-333

 

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)

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center, Massachusetts General Hospital

Overall PI:
Jennifer Brown, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Jon Arnason, MD, Beth Israel Deaconess Medical Center

Contacts:
Dana-Farber Cancer Institute: Ilene Galinsky, 617-632-3902, igalinsky@partners.org
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

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 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. Exclusion Criteria: - 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/allogeneic transplant - 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.
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