A Phase 3 Extension Study of Duvelisib and Ofatumumab in Patients With CLL/SLL Previously Enrolled in Study IPI-145-07
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|ClinicalTrials.gov Identifier: NCT02049515|
Recruitment Status : Enrolling by invitation
First Posted : January 30, 2014
Last Update Posted : October 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma||Drug: IPI-145 (duvelisib) Drug: Ofatumumab||Phase 3|
This is an open-label, two- arm, extension study designed to enable subjects who have experienced radiologically- confirmed disease progression in Study IPI-145-07 to receive the alternative treatment (either IPI-145 or ofatumumab) than what was received during study IPI-145-07.
Subjects who have previously received ofatumumab in study IPI-145-07 will receive a starting dose of 25 mg IPI-145 BID continuously in a 21 day cycle for Cycle 1 followed by 28- day treatment cycles thereafter for up to 11 cycles or until disease progression, discontinuation from study participation, or start of subsequent therapy, whichever comes first. After completing approximately 11 cycles of treatment with duvelisib, subjects who, in the judgment of the Investigator, may derive benefit from continued treatment may continue to receive additional cycles of duvelisib until disease progression or unacceptable toxicity. However, to receive additional cycles of duvelisib beyond 11 cycles, subjects must have evidence of response and CLL/SLL requiring treatment according to the IWCLL/IWG by Cycle 12 Day 1.
Subjects who have previously received IPI-145 in study IPI-145-07 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 unless disease progression or unacceptable toxicity occurs. Administration of ofatumumab will not exceed the 12 doses (within 7 cycles).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of IPI-145 and Ofatumumab in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Previously Enrolled in Study IPI-145-07|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
IPI-145 is administered orally and supplied as 5 mg and 25 mg formulated capsules.
Drug: IPI-145 (duvelisib)
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
- Overall response rate (ORR) [ Time Frame: Until progressive disease, death, or other anticancer therapy is initiated (up to 6 years) ]
- Treatment-emergent adverse events (TEAEs) and changes in safety laboratory values [ Time Frame: Enrollment through 30 days after the last dose of either IPI-145 or Ofatumumab ]
- Duration of Response [ Time Frame: From the first documentation of response to the first documentation of PD or death due to any cause (up to 6 years) ]
- Progression-free survival (PFS) [ Time Frame: From the first dose of study treatment to the first documentation of PD or death from any cause (up to 6 years) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049515
|Study Chair:||Hagop Youssoufian, MD||Verastem, Inc.|