A Phase 3 Study of IPI-145 Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO)
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).
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 3 Study of IPI-145 Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma (DUO)|
- Progression-free survival (PFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years ] [ Designated as safety issue: No ]
- Overall response rate (ORR) [ Time Frame: Until disease progression or unacceptable toxicity assessed up to 3 years ] [ Designated as safety issue: No ]
- Hematologic improvements [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: Every 6 months for up to 3 years after first dose ] [ Designated as safety issue: No ]
- Lymph node response rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]Lymph node response defined as greater than or equal to 50% decrease in the SPD of target lymph nodes
- Duration of Response (DOR) [ Time Frame: Time from the first documentation of response to first documentation of progressive disease or death due to any cause ] [ Designated as safety issue: No ]
- Safety [ Time Frame: 30 days plus 7 days from last dose ] [ Designated as safety issue: Yes ]Treatment- emergent adverse events (TEAEs) and changes in safety laboratory values
- Pharmacokinetics (PK) [ Time Frame: Cycle 2, Cycle 3, and Cycle 7 ] [ Designated as safety issue: No ]Evaluate the PK of IPI-145 and, if applicable, its metabolite(s)
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
IPI-145 is administered orally and supplied as 5 mg and 25 mg formulated capsules
Other Name: PI3K Inhibitor
Active Comparator: Ofatumumab
Ofatumumab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg/5mL and 1000 mg/50 mL
Other Name: Arzerra
This is an open-label, two- arm, randomized phase 3, superiority trial designed to evaluate the efficacy and safety of IPI-145 compared to ofatumumab administered to patients who have been diagnosed with CLL/SLL whose disease is relapsed or refractory.
Approximately 150 subjects will receive a starting dose of 25 mg IPI-145 BID initially over the course of 21-day treatment cycle followed by 28-day treatment cycles for up to 18 cycles.
Approximately 150 subjects will receive a starting dose of 300 mg ofatumumab on Day 1 followed by seven weekly doses of 2000 mg. Thereafter, subjects will receive 2000 mg ofatumumab once every month for four months. Administration of ofatumumab will not exceed the 12 doses (within 7 cycles).
Please refer to this study by its ClinicalTrials.gov identifier: NCT02004522
|Contact: Fiona Pattersonfirstname.lastname@example.org|
Show 89 Study Locations
|Study Director:||Patrick Kelly, MD||Infinity Pharmaceuticals, Inc.|