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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01659021
Registration number
NCT01659021
Ethics application status
Date submitted
3/08/2012
Date registered
7/08/2012
Titles & IDs
Public title
Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia
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Scientific title
A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia
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Secondary ID [1]
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2012-001236-65
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Secondary ID [2]
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GS-US-312-0119
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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 - Ofatumumab
Experimental: Idelalisib+ofatumumab - Randomized Initial Therapy (24 weeks): Idelalisib + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)
Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation.
Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.
Active comparator: Ofatumumab - Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)
Continuing Therapy/Observation: Observation until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation.
Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.
Treatment: Drugs: Idelalisib
150 mg tablets administered orally twice daily
Treatment: Drugs: Ofatumumab
Administered intravenously
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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) was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by = 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or = 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL. PFS was analyzed using Kaplan-Meier (KM) estimates.
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Timepoint [1]
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Randomization to End of Study (up to 60 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 was defined as the percentage of participants who achieved a best overall response of complete response or partial response.
* Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate \& biopsy.
* Partial response 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. Overall response rate was analyzed using KM estimates.
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Timepoint [1]
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Randomization to End of Study (up to 60 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 proportion of participants who achieved a = 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lymph nodes.
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Timepoint [2]
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Randomization to End of Study (up to 60 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 was defined as the interval from randomization to death from any cause. Overall survival was analyzed using KM estimates.
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Timepoint [3]
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Randomization to Last Long-Term Follow-Up Visit (up to maximum of 5 years)
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Secondary outcome [4]
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Progression-Free Survival in Subgroup of Participants With Chromosome 17p Deletion and/or TP53 Mutation
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Assessment method [4]
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Progression-free survival in subgroup of participants with chromosome 17p deletion and/or TP53 mutation was analyzed using KM estimates.
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Timepoint [4]
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Randomization to End of Study (up to 60 months)
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Secondary outcome [5]
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Complete Response Rate
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Assessment method [5]
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Complete response rate was defined as the percentage of participants who achieve a complete response and maintain their response for at least 8 weeks (with a 1-week window).
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Timepoint [5]
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Randomization to End of Study (up to 60 months)
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Eligibility
Key inclusion criteria
Key
* Adults with previously treated recurrent CLL who have measurable lymphadenopathy
* Require therapy for CLL
* Have experienced CLL progression < 24 months since the completion of the last prior therapy
* Have disease that is not refractory to ofatumumab
Note: Other protocol defined Inclusion/
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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
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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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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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
4/12/2012
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Date of last participant enrolment
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Date of last data collection
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Actual
15/08/2018
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Sample size
Target
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Accrual to date
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Final
261
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Saint George and Sutherland Hospitals - Kogarah
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Prince of Wales Hospital - Randwick
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Westmead Hospital - Westmead
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Royal Brisbane and Women's Hospital - Herston
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Haematology and Oncology Clinics of Australia at Mater - Milton
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Ashford Cancer Centre Research - Ashford
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Box Hill Hospital - Box Hill
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Frankston Hospital - Melbourne
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Queen Elizabeth Hospital - Woodville
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2217 - Kogarah
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2031 - Randwick
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2145 - Westmead
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4029 - Herston
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4064 - Milton
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5035 - Ashford
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3128 - Box Hill
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3199 - Melbourne
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5011 - Woodville
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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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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 to ofatumumab on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL).
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Trial website
https://clinicaltrials.gov/study/NCT01659021
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Trial related presentations / publications
Jones JA, Robak T, Brown JR, Awan FT, Badoux X, Coutre S, Loscertales J, Taylor K, Vandenberghe E, Wach M, Wagner-Johnston N, Ysebaert L, Dreiling L, Dubowy R, Xing G, Flinn IW, Owen C. Efficacy and safety of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukaemia: an open-label, randomised phase 3 trial. Lancet Haematol. 2017 Mar;4(3):e114-e126. doi: 10.1016/S2352-3026(17)30019-4. Jones J, Robak T, Wach M, Brown JR, Menter AR, Vandenberghe E, et al. Updated results of a phase 3 randomized, controlled study of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukemia (CLL) [Poster 7515]. American Society of Clinical Oncology (ASCO) 52nd Annual Meeting; 2016 02 - 06 June; Chicago, IL. Jones JA, Wach M, Robak T, Brown JR, Menter AR, Vanderberghe E, et al. Results of a Phase 3 Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (IDELA) in Combination with Ofatumumab (OFA) for Previously Treated Chronic Lymphocytic Leukemia (CLL) [Poster 7023]. American Society of Clinical Oncology (ASCO) 51st Annual Meeting; 2015 29 May - 02 June; Chicago, IL. Robak T, Jones J, Wach M, Brown JR, Menter AR, Vandenberghe E, et al. Updated results of a phase 3 randomized, controlled study of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukemia (CLL) [Poster 213]. 21st Congress of the European Hematology Association (EHA); 2015 09-12 June; Copenhagen, Denmark. Robak T, Wach M, Jones J, Owen C, Brown J, Menter A, et al. Results Of A Phase 3 Randomized Controlled Study Evaluating The Efficacy And Safety Of Idelalisib (Idela) In Combination With Ofatumumab (Ofa) For Previously Treated Chronic Lymphocytic Leukemia (CLL) [Poster LB598]. 20th Congress of the European Hematology Association (EHA); 2015 11-14 June; Vienna, Austria. Flinn I, Kimby E, Cotter FE, Giles FJ, Janssens A, Pulczynski EJ, et al. A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination with Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia (CLL) [Poster TPS7131]. American Society of Clinical Oncology (ASCO); 2013 May 31-June 4; Chicago, IL. Gordon MJ, Huang J, Chan RJ, Bhargava P, Danilov AV. Medical comorbidities in patients with chronic lymphocytic leukaemia treated with idelalisib: analysis of two large randomised clinical trials. Br J Haematol. 2021 Feb;192(4):720-728. doi: 10.1111/bjh.16879. Epub 2020 Jun 29.
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Public notes
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Contacts
Principal investigator
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Gilead Study Director
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Address
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Gilead Sciences
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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)
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When will data be available (start and end dates)?
18 months after study completion
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Available to whom?
A secured external environment with username, password, and RSA code.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://www.gilead.com/research/disclosure-and-transparency
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/21/NCT01659021/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/21/NCT01659021/SAP_001.pdf
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Jones JA, Robak T, Brown JR, Awan FT, Badoux X, Co...
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Journal
Jones J, Robak T, Wach M, Brown JR, Menter AR, Van...
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Journal
Jones JA, Wach M, Robak T, Brown JR, Menter AR, Va...
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Journal
Robak T, Jones J, Wach M, Brown JR, Menter AR, Van...
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Journal
Robak T, Wach M, Jones J, Owen C, Brown J, Menter ...
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Journal
Flinn I, Kimby E, Cotter FE, Giles FJ, Janssens A,...
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Results are available at
https://clinicaltrials.gov/study/NCT01659021