Clinical Trial: Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase 2, Single Arm Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With
Brief Summary:
The primary objective of this study is to evaluate overall response rate (ORR) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion.
An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.
Detailed Summary:
Sponsor: Gilead Sciences
Current Primary Outcome: Overall Response Rate
Original Primary Outcome: Overall Response Rate [ Time Frame: Up to 10 years ]
Current Secondary Outcome:
- Duration of ResponseDuration of response (DOR) was defined as the interval from the first documentation of confirmed complete response or partial response (by IRC) to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is chronic lymphocytic leukemia (CLL) progression based on standard criteria, excluding lymphocytosis alone.
- Nodal Response RateNodal response rate was defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an IRC.
- Complete Response RateComplete response rate was defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.
- Progression-Free SurvivalProgression-free survival (PFS) was defined as the interval from first dose of study drug to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an IRC.
- Overall SurvivalOverall survival was defined as the interval from the start of study treatment to death from any cause.
- Minimal Residual Disease Negativity Rate at Week 36Minimal residual disease (MRD) negativity rate was defined as the proportion of participants with MRD < 10^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation. For participants receiving the final dose of rituximab after the original scheduled date, the MRD assessment will be performed no fewer than 12 weeks after the last dose of rituximab.
Original Secondary Outcome:
- Duration of Response [ Time Frame: Up to 10 years ]Duration of response (DOR) is defined as the interval from the first documentation of CR or PR to the first documentation of definitive disease progression or death from any cause.
- Complete Response Rate [ Time Frame: Up to 10 years ]Complete response (CR) rate is defined as the proportion of participants who achieve a CR
- Progression-Free Survival [ Time Frame: Up to 10 years ]Progression-free survival (PFS) is defined as the interval from the first dose of study drug to the first documentation of definitive disease progression or death from any cause.
- Minimal residual disease negativity rate [ Time Frame: Up to 10 years ]Minimal residual disease (MRD) negativity rate is defined as the proportion of participants with MRD <10^-4, as assessed by flow cytometry in bone marrow at Week 36 after therapy initiation.
- Nodal Response Rate [ Time Frame: Up to 10 years ]Nodal response rate is defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lesions.
- Overall Survival [ Time Frame: Up to 10 years ]Overall survival (OS) is defined as the interval from the start of study treatment to death from any cause.
Information By: Gilead Sciences
Dates:
Date Received: January 22, 2014
Date Started: August 6, 2014
Date Completion:
Last Updated: March 30, 2017
Last Verified: March 2017