A Phase 3 Study of IPI-145 Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO)

Status: Recruiting
Diagnosis: Leukemia/MDS
NCT ID: NCT02004522 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-539


A Phase 3 clinical trial to examine the efficacy of IPI 145 monotherapy versus ofatumumab monotherapy in subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).


Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Matthew Davids, MD, Dana Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Ilene Galinsky, 617-632-3902, igalinsky@partners.org

Eligibility Criteria

Inclusion Criteria: - Diagnosis of CLL or SLL that meets at least 1 of the IWCLL 2008 criteria or IWG 2007 criteria for requiring treatment - Must have received at least one prior therapy for CLL/SLL - Measurable nodal disease by CT - ECOG performance status of 0-2 - Considered not appropriate for treatment or retreatment with purine analog-based therapy - Cytogenetics or FISH performed within 24 months prior to randomization Exclusion Criteria: - History of Richter's transformation or prolymphocytic leukemia - Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenia (ITP) - Prior allogeneic transplant - Known central nervous system lymphoma or leukemia - Previous treatment with a PI3K inhibitor - Tyrosine kinase inhibitor within 7 days of randomization - Ongoing systemic bacterial, fungal, or viral infections - History of tuberculosis within preceding two years - Prior, current, or chronic hepatitis B or hepatitis C infection - History of stroke, unstable angina, myocardial infarction or ventricular arrhythmia requiring medication or mechanical control within the last 6 months
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