Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia
NCT ID: NCT01980875
Last Updated: 2018-11-19
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
57 participants
INTERVENTIONAL
2015-04-21
2016-05-13
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Safety Run-In: Idelalisib+obinutuzumab
Participants will receive idelalisib for 96 weeks and obinutuzumab over 21 weeks. Following 4 weeks of treatment, safety data will be reviewed by an independent data monitoring committee (DMC). If acceptable tolerability is observed, the randomized portion of the study will begin.
Idelalisib
150 mg tablet administered orally twice daily
Obinutuzumab
1000 mg/40 mL single-use vials administered intravenously for a total of 8 doses over 21 weeks
Randomized: Idelalisib+obinutuzumab
Participants will receive idelalisib for 96 weeks and obinutuzumab over 21 weeks.
Idelalisib
150 mg tablet administered orally twice daily
Obinutuzumab
1000 mg/40 mL single-use vials administered intravenously for a total of 8 doses over 21 weeks
Randomized: Obinutuzumab+chlorambucil
Participants will receive obinutuzumab over 21 weeks and chlorambucil over 23 weeks.
Chlorambucil
2 mg tablets administered at a dose of 0.5 mg/kg orally every other week for a total of 12 doses
Obinutuzumab
1000 mg/40 mL single-use vials administered intravenously for a total of 8 doses over 21 weeks
Interventions
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Idelalisib
150 mg tablet administered orally twice daily
Chlorambucil
2 mg tablets administered at a dose of 0.5 mg/kg orally every other week for a total of 12 doses
Obinutuzumab
1000 mg/40 mL single-use vials administered intravenously for a total of 8 doses over 21 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. creatinine clearance \< 70 mL/min, or
2. Cumulative Illness Rating Scale score \> 6, by assessment of the investigator
* Diagnosis of B-cell CLL, with diagnosis established according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL)
* 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
Exclusion Criteria
* Known presence of myelodysplastic syndrome
* Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
* Ongoing liver injury
* Ongoing drug-induced pneumonitis
* Ongoing inflammatory bowel disease
* History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
* Ongoing immunosuppressive therapy other than corticosteroids
* Concurrent participation in another therapeutic clinical trial
* Undergone major surgery within 30 days prior to randomization
* Known hypersensitivity or intolerance to any of the active substances or excipients in the formulations for idelalisib, obinutuzumab, or chlorambucil
* History of non-infectious pneumonitis
* Received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Sansum Clinic
Santa Barbara, California, United States
UCLA Jonsson Comprehensive Cancer Center
Santa Monica, California, United States
Innovative Clinical Research Institute
Whittier, California, United States
Cancer Center of Central Connecticut
Southington, Connecticut, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
Saint Francis Cancer Center
Greenville, South Carolina, United States
St Vincent Hospital, Sydney
Darlinghurst, New South Wales, Australia
UZ Ghent- hematology
Ghent, , Belgium
Royal Victoria Regional Health Centre - Simcoe Musk
Barrie, Ontario, Canada
Centre Hospitalier du Mans
Le Mans, , France
Centre Hospitalier de Perpignan
Perpignan, , France
Szpital Specjalistyczny w Brzozowie, Oddzial Hematologii Onkologicznej
Brzozów, Podkarpackie Voivodeship, Poland
Malopolskie Centrum Medyczne s.c.
Krakow, , Poland
Wojewódzki Szpital Specjalistyczny w Legnicy
Legnica, , Poland
Wojewodzki Szpital Specjalistyczny, im. M. Kopernika Klinika Hematologii Uniwersytetu Medycznego
Lodz, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim Centrum Onkologii w Olsztynie Oddzial Hematologii
Olsztyn, , Poland
Hospital Universitario de Salamanca
Salamanca, , Spain
East Kent Hospitals University NHS Foundation Trust
Canterbury, Kent, United Kingdom
Countries
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Other Identifiers
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2013-004551-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-312-0118
Identifier Type: -
Identifier Source: org_study_id
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