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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01659021




Registration number
NCT01659021
Ethics application status
Date submitted
3/08/2012
Date registered
7/08/2012
Date last updated
14/08/2019

Titles & IDs
Public title
Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia
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
Secondary ID [1] 0 0
2012-001236-65
Secondary ID [2] 0 0
GS-US-312-0119
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 - 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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival - 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.
Timepoint [1] 0 0
Randomization to End of Study (up to 60 months)
Secondary outcome [1] 0 0
Overall Response Rate - 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.
Timepoint [1] 0 0
Randomization to End of Study (up to 60 months)
Secondary outcome [2] 0 0
Lymph Node Response Rate - 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.
Timepoint [2] 0 0
Randomization to End of Study (up to 60 months)
Secondary outcome [3] 0 0
Overall Survival - Overall survival was defined as the interval from randomization to death from any cause. Overall survival was analyzed using KM estimates.
Timepoint [3] 0 0
Randomization to Last Long-Term Follow-Up Visit (up to maximum of 5 years)
Secondary outcome [4] 0 0
Progression-Free Survival in Subgroup of Participants With Chromosome 17p Deletion and/or TP53 Mutation - Progression-free survival in subgroup of participants with chromosome 17p deletion and/or TP53 mutation was analyzed using KM estimates.
Timepoint [4] 0 0
Randomization to End of Study (up to 60 months)
Secondary outcome [5] 0 0
Complete Response Rate - 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).
Timepoint [5] 0 0
Randomization to End of Study (up to 60 months)

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/
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Saint George and Sutherland Hospitals - Kogarah
Recruitment hospital [2] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [5] 0 0
Haematology and Oncology Clinics of Australia at Mater - Milton
Recruitment hospital [6] 0 0
Ashford Cancer Centre Research - Ashford
Recruitment hospital [7] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [8] 0 0
Frankston Hospital - Melbourne
Recruitment hospital [9] 0 0
Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
4064 - Milton
Recruitment postcode(s) [6] 0 0
5035 - Ashford
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3199 - Melbourne
Recruitment postcode(s) [9] 0 0
5011 - Woodville
Recruitment outside Australia
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Washington
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Belgium
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Antwerpen
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Belgium
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Brussels
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Ghent
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Leuven
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Aalborg
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Dublin
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Pomorskie
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Lódz
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Luleå
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Stockholm
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Norfolk
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Oxford

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

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/show/NCT01659021
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01659021