A Phase 3 Extension Study of IPI-145 and Ofatumumab in Patients With CLL/SLL Previously Enrolled in Study IPI-145-07

Status: Recruiting
Diagnosis: Lymphoma
NCT ID: NCT02049515 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 14-059


A Phase 3 (extension) clinical trial to examine the efficacy of IPI-145 monotherapy or ofatumumab monotherapy in subjects with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who experienced disease progression after treatment with IPI-145 or Ofatumumab in Study IPI-145-07.


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: Kathleen McDermott, kmcdermott@partners.org

Eligibility Criteria

Inclusion Criteria: - Received either IPI-145 or ofatumumab while participating in study IPI-145-07 and experienced radiologically-confirmed disease progression - Diagnosis of active CLL or SLL that meets at least 1 of the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria for requiring treatment - Measurable nodal disease by CT - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Exclusion Criteria: - Discontinued study participation in Infinity- sponsored IPI-145-07 study - Greater than 3 months from confirmed progressive disease on Study IPI-145-07 - History of Richter's transformation or prolymphocytic leukemia - Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenia purpura (ITP) - Known central nervous system lymphoma or leukemia - Use of any anticancer medication from documented PD on Study IPI-145-07 to enrollment - Ongoing systemic bacterial, fungal, or viral infections - Prior, current, or chronic hepatitis B or hepatitis C infection
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