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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/NCT01569295
Registration number
NCT01569295
Ethics application status
Date submitted
27/03/2012
Date registered
3/04/2012
Date last updated
10/03/2020
Titles & IDs
Public title
Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )
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Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia
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Secondary ID [1]
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2011-006292-20
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Secondary ID [2]
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GS-US-312-0115
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Universal Trial Number (UTN)
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Trial acronym
Tugela
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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 - Rituximab
Treatment: Drugs - Bendamustine
Treatment: Drugs - Placebo to match idelalisib
Experimental: Idelalisib+bendamustine+rituximab - Participants will receive idelalisib plus bendamustine and rituximab
Placebo Comparator: Placebo to match idelalisib+bendamustine+rituximab - Participants will receive placebo to match idelalisib plus bendamustine and rituximab
Treatment: Drugs: Idelalisib
Idelalisib 150 mg administered orally twice daily
Treatment: Drugs: Rituximab
Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a maximum of 6 infusions
Treatment: Drugs: Bendamustine
Bendamustine 70 mg/mg^2/day on 2 consecutive days every 28 days administered intravenously for a maximum of 12 infusions
Treatment: Drugs: Placebo to match idelalisib
Placebo to match idelalisib administered orally twice daily
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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 (PFS)
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Assessment method [1]
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PFS was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. PFS (months) = (minimum (date of disease progression, date of death) - date of randomization + 1)/30.4375.
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Timepoint [1]
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Up to 84 months
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Secondary outcome [1]
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Overall Response Rate (ORR)
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Assessment method [1]
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ORR was the percentage of participants who achieved a complete response (CR), CR with incomplete marrow recovery (CRi,) or partial response (PR) and maintained the response for at least 12 weeks. CR was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy.
PR was defined as >1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus = 1 of the following: = 1500/µL absolute neutrophil count, > 100000/µL platelets, > 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors. CRi was defined as all criteria for CR met but with persistent anemia, thrombocytopenia, neutropenia or a hypocellular bone marrow.
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Timepoint [1]
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Up to 84 months
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Secondary outcome [2]
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Lymph Node Response Rate
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Assessment method [2]
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Lymph node response rate was defined as the percentage of participants who achieved a = 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lesions.
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Timepoint [2]
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Up to 84 months
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Secondary outcome [3]
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Overall Survival
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Assessment method [3]
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Overall survival (OS) was defined as the interval from randomization to death from any cause. Overall survival (months) = (date of death - date of randomization + 1)/30.4375.
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Timepoint [3]
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Up to 84 months
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Secondary outcome [4]
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Complete Response Rate
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Assessment method [4]
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Complete response (CR) rate was defined as the percentage of participants who achieved a CR.
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Timepoint [4]
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Up to 84 months
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Eligibility
Key inclusion criteria
Key
- Previously treated recurrent CLL
- Measurable lymphadenopathy
- Requires therapy for CLL
- Has experienced CLL progression < 36 months since the completion of the last prior
therapy
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Minimum age
18
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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
- Recent history of a major non-CLL malignancy
- Evidence of an ongoing infection
- CLL refractory to bendamustine
- Concurrent participation in another therapeutic clinical trial
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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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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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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
15/06/2012
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Date of last participant enrolment
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Date of last data collection
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Actual
10/06/2019
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Sample size
Target
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Accrual to date
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Final
416
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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St Vincent's Hospital - Sydney - Darlinghurst
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Gosford Hospital - Gosford
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Princess Alexandra Hospital - Woolloongabba
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Royal Adelaide Hospital - Adelaide
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Monash Medical Centre - Clayton Campus - Clayton
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Sir Charles Gairdner Hospital - Nedlands
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2010 - Darlinghurst
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2250 - Gosford
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4102 - Woolloongabba
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5000 - Adelaide
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3168 - Clayton
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Recruitment postcode(s) [6]
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6009 - Nedlands
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Gilead Sciences
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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 effect of the addition of idelalisib
(formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in
participants with previously treated chronic lymphocytic leukemia (CLL)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01569295
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Trial related presentations / publications
Zelenetz AD, Robak T, et al. Idelalisib Plus Bendamustine and Rituximab (BR) Is Superior to BR Alone in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Results of a Phase 3 Randomized Double-Blind Placebo-Controlled Study. American Society ofHematology (ASH) 57th Annual Meeting & Exposition; 5-8 December 2015; Orlando, FL.
Barrientos JC, Brown JR, et al. Results of a Randomized Double-Blind Placebo-Controlled Phase 3 study Evaluating Idelalisib in Combination with Bendamustine and Rituximab in Patients with Relapsed/Refractory CLL and Adverse Prognostic Features. American Society of Clinical Oncology (ASCO) 2016 Annual Meeting; 3-7 June 2016; Chicago, IL.
Hillmen, P, Ferra C, et al. Idelalisib in Combination with Bendamustine and Rituximab Improves Overall Survival in Patients with Relapsed/Refractory CLL: Interim Results of a Phase 3 Randomized Double-Blind Placebo-Controlled Study. European Hematology Association (EHA) 21st Annual Meeting; 9-12 June 2016; Copenhagen, Denmark.
Zelenetz AD, Brown JR et al. Updated Analysis of Overall Survival in Randomized Phase III Study of Idelalisib in Combination with Bendamustine and Rituximab in Patients with Relapsed/Refractory CLL. American Society of Hematology (ASH) 58th Annual Meeting & Exposition; 3-6 December 2016; San Diego, CA
Zelenetz AD, Barrientos JC, Brown JR, Coiffier B, Delgado J, Egyed M, Ghia P, Illes A, Jurczak W, Marlton P, Montillo M, Morschhauser F, Pristupa AS, Robak T, Sharman JP, Simpson D, Smolej L, Tausch E, Adewoye AH, Dreiling LK, Kim Y, Stilgenbauer S, Hillmen P. Idelalisib or placebo in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukaemia: interim results from a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2017 Mar;18(3):297-311. doi: 10.1016/S1470-2045(16)30671-4. Epub 2017 Jan 28.
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Public notes
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Contacts
Principal investigator
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Gilead Study Director
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Gilead Sciences
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01569295
Download to PDF