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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01980875
Registration number
NCT01980875
Ethics application status
Date submitted
5/11/2013
Date registered
11/11/2013
Date last updated
19/11/2018
Titles & IDs
Public title
Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia
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Scientific title
A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia
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Secondary ID [1]
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2013-004551-20
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Secondary ID [2]
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GS-US-312-0118
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Idelalisib
Treatment: Drugs - Chlorambucil
Treatment: Drugs - Obinutuzumab
Experimental: 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.
Experimental: Randomized: Idelalisib+obinutuzumab - Participants will receive idelalisib for 96 weeks and obinutuzumab over 21 weeks.
Active Comparator: Randomized: Obinutuzumab+chlorambucil - Participants will receive obinutuzumab over 21 weeks and chlorambucil over 23 weeks.
Treatment: Drugs: Idelalisib
150 mg tablet administered orally twice daily
Treatment: Drugs: Chlorambucil
2 mg tablets administered at a dose of 0.5 mg/kg orally every other week for a total of 12 doses
Treatment: Drugs: Obinutuzumab
1000 mg/40 mL single-use vials administered intravenously for a total of 8 doses over 21 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival
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Assessment method [1]
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Progression-free survival (PFS) is defined as the interval from randomization 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 independent review committee (IRC).
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Timepoint [1]
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Up to 11 months
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Secondary outcome [1]
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Overall Response Rate
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Assessment method [1]
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Overall response rate (ORR) is defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an IRC.
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Timepoint [1]
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Up to 11 months
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Secondary outcome [2]
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Nodal Response Rate
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Assessment method [2]
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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 of index lesions. Nodal response rate was to be assessed by an IRC.
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Timepoint [2]
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Up to 11 months
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Secondary outcome [3]
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Complete Response Rate
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Assessment method [3]
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Complete response rate is defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.
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Timepoint [3]
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Up to 11 months
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Secondary outcome [4]
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Overall Survival
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Assessment method [4]
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Overall survival is defined as the interval from randomization to death from any cause. Overall survival was to be assessed by an IRC.
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Timepoint [4]
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Up to 11 months
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Secondary outcome [5]
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Minimal Residual Disease Negativity Rate at Week 36
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Assessment method [5]
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Minimal residual disease (MRD) negativity rate is 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 obinutuzumab after the original scheduled date, the MRD assessment was performed no less than 12 weeks after the last dose of obinutuzumab. MRD negativity rate was to be assessed by an IRC.
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Timepoint [5]
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Up to 11 months
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Eligibility
Key inclusion criteria
Key
- Not a candidate for fludarabine therapy based on either:
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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Known histological transformation from CLL to an aggressive lymphoma (ie, Richter
transformation)
- 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/04/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
13/05/2016
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Sample size
Target
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Accrual to date
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Final
57
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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St Vincent Hospital, Sydney - Darlinghurst
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Connecticut
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United States of America
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Ohio
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United States of America
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South Carolina
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Belgium
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Ghent
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Canada
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Ontario
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France
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Le Mans
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France
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State/province [8]
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Perpignan Cedex 9
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Country [9]
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Poland
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State/province [9]
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Podkarpackie
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Poland
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Krakow
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Poland
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State/province [11]
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Legnica
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Poland
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Lodz
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Poland
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Olsztyn
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Spain
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State/province [14]
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Salamanca
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Country [15]
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United Kingdom
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State/province [15]
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Kent
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Gilead Sciences
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective of this study is to evaluate the effects of idelalisib with
obinutuzumab versus the combination of chlorambucil and obinutuzumab on progression-free
survival (PFS) in participants with previously untreated chronic lymphocytic leukemia (CLL).
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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Trial website
https://clinicaltrials.gov/ct2/show/NCT01980875
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gilead Study Director
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Address
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Gilead Sciences
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Fax
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Email
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Contact person for public queries
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Address
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01980875
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