Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion
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|ClinicalTrials.gov Identifier: NCT02044822|
Recruitment Status : Terminated
First Posted : January 24, 2014
Results First Posted : May 11, 2017
Last Update Posted : November 19, 2018
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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.
|Condition or disease||Intervention/treatment||Phase|
|B-cell Chronic Lymphocytic Leukemia (CLL) With 17p Deletion||Drug: Idelalisib Drug: Rituximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 17p Deletion|
|Actual Study Start Date :||August 6, 2014|
|Actual Primary Completion Date :||April 27, 2016|
|Actual Study Completion Date :||May 17, 2016|
Experimental: Idelalisib + rituximab
Participants will receive rituximab for 8 weeks and Idelalisib continuously throughout the study (up to 10 years).
150 mg tablets administered orally twice daily
375 mg/m^2 administered intravenously once weekly x 8 weeks
Other Name: Rituxan
- Overall Response RateOverall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an independent review committee (IRC).
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Key Inclusion Criteria:
- Documented diagnosis of B-cell CLL, according to International Workshop on Chronic Lymphocytic Leukemia 2008
- Presence of 17p deletion in CLL cells as demonstrated by fluorescence in-situ hybridization (FISH) testing
- No prior therapy for CLL other than corticosteroids for disease complications
- CLL that warrants treatment
- Presence of measurable lymphadenopathy
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Key Exclusion Criteria:
- Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
- Known presence of myelodysplastic syndrome
History of a non-CLL malignancy except for the following:
- the malignancy has been in remission without treatment for ≥ 5 years prior to enrollment, or
- carcinoma in situ of the cervix, or
- adequately treated basal or squamous cell skin cancer or other localized non-melanoma skin cancer, or
- asymptomatic prostate cancer without known metastatic disease and with no current requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for ≥ 1 year prior to enrollment, or
- ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone, or
- other adequately treated Stage 1 or 2 cancer currently in complete remission
- Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment
- Ongoing liver injury
- History of noninfectious pneumonitis
- Ongoing inflammatory bowel disease
- History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
- Ongoing immunosuppressive therapy other than corticosteroids
- Received last dose of study drug on another therapeutic clinical trial within 30 days prior to enrollment
- Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram (ECG) finding, or laboratory abnormality
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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): NCT02044822
|Study Director:||Gilead Study Director||Gilead Sciences|
|Responsible Party:||Gilead Sciences|
|Other Study ID Numbers:||
2013-003314-41 ( EudraCT Number )
|First Posted:||January 24, 2014 Key Record Dates|
|Results First Posted:||May 11, 2017|
|Last Update Posted:||November 19, 2018|
|Last Verified:||March 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.|
Statistical Analysis Plan (SAP)
|Time Frame:||18 months after study completion|
|Access Criteria:||A secured external environment with username, password, and RSA code.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Chronic Lymphocytic Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents, Immunological
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action