A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO)
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|ClinicalTrials.gov Identifier: NCT02004522|
Recruitment Status : Active, not recruiting
First Posted : December 9, 2013
Results First Posted : January 8, 2019
Last Update Posted : January 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma||Drug: Duvelisib Drug: Ofatumumab||Phase 3|
This is an open-label, two- arm, randomized phase 3, superiority trial designed to evaluate the efficacy and safety of duvelisib 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 duvelisib BID initially over the course of 21-day treatment cycle followed by 28-day treatment cycles for up to 18 cycles or until disease progression or unacceptable toxicity (whichever comes first). After 18 complete cycles of treatment, subjects may receive additional cycles of duvelisib until disease progression or unacceptable toxicity if they, in the judgment of the Investigator, may derive benefit from continued treatment, and if the subject meets the criteria for additional treatment at Cycle 19 Day 1.
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||319 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma (DUO)|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||May 19, 2017|
|Estimated Study Completion Date :||June 2021|
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules
Other Name: Copiktra, IPI-145, 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
- 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 ]The primary efficacy endpoint for the study was PFS, defined as time from randomization to the first documentation of PD as determined by blinded independent review or death due to any cause.
- Overall Response Rate (ORR) [ Time Frame: Until disease progression or unacceptable toxicity assessed up to 6 years ]ORR is a key secondary efficacy endpoint with overall response defined as best response of CR, CRi, PR, or PRwL, according to the modified IWCLL/IWG Response Criteria, with modification for treatment-related lymphocytosis as defined in the protocol.
- Number of Subjects With Hematologic Improvements [ Time Frame: 3 years ]Subjects with hematologic improvement included those subjects with abnormally high values for neutrophil count, hemoglobin, or platelet count at Baseline determined to have consistently met the criteria of an improvement for those parameters for a period of at least 60 days during which the subject did not have a transfusion or exogenous cytokines.
- Overall Survival [ Time Frame: Every 6 months for up to 3 years after first dose ]A stratified Cox regression analysis was used to test for any treatment effect.
- Lymph Node Response Rate [ Time Frame: 3 years ]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 ]Duration of response is defined only for subjects demonstrating a response (eg, CR, CRi, PR, PRwL), with the response and progression statuses both determined by the blinded, central independent review. The analysis will be descriptive for each treatment group only.
- Treatment- Emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values [ Time Frame: 04 Feb 2014 - 19 June 2018 ]An analysis of TEAEs with an onset within the first 24 weeks of treatment was performed to examine and compare the incidence of events across an equal period for each treatment arm.Twenty-four weeks was anticipated to be the median exposure to ofatumumab.
- Number of Subjects With Samples Available for Duvelisib Pharmacokinetics (PK) [ Time Frame: Cycle 2, Cycle 3, and Cycle 7 ]Number of subjects with samples available for duvelisib Pharmacokinetics (PK)
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): NCT02004522
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|Study Chair:||Hagop Youssoufian, MD||Verastem, Inc.|