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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01980875




Registration number
NCT01980875
Ethics application status
Date submitted
5/11/2013
Date registered
11/11/2013

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
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
Secondary ID [1] 0 0
2013-004551-20
Secondary ID [2] 0 0
GS-US-312-0118
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival
Timepoint [1] 0 0
Up to 11 months
Secondary outcome [1] 0 0
Overall Response Rate
Timepoint [1] 0 0
Up to 11 months
Secondary outcome [2] 0 0
Nodal Response Rate
Timepoint [2] 0 0
Up to 11 months
Secondary outcome [3] 0 0
Complete Response Rate
Timepoint [3] 0 0
Up to 11 months
Secondary outcome [4] 0 0
Overall Survival
Timepoint [4] 0 0
Up to 11 months
Secondary outcome [5] 0 0
Minimal Residual Disease Negativity Rate at Week 36
Timepoint [5] 0 0
Up to 11 months

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

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/05/2016
Sample size
Target
Accrual to date
Final
57
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St Vincent Hospital, Sydney - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
United States of America
State/province [4] 0 0
South Carolina
Country [5] 0 0
Belgium
State/province [5] 0 0
Ghent
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
France
State/province [7] 0 0
Le Mans
Country [8] 0 0
France
State/province [8] 0 0
Perpignan Cedex 9
Country [9] 0 0
Poland
State/province [9] 0 0
Podkarpackie
Country [10] 0 0
Poland
State/province [10] 0 0
Krakow
Country [11] 0 0
Poland
State/province [11] 0 0
Legnica
Country [12] 0 0
Poland
State/province [12] 0 0
Lodz
Country [13] 0 0
Poland
State/province [13] 0 0
Olsztyn
Country [14] 0 0
Spain
State/province [14] 0 0
Salamanca
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Kent

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
18 months after study completion
Available to whom?
A secured external environment with username, password, and RSA code.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.gilead.com/research/disclosure-and-transparency


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01980875