Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Registration Number
- NCT01659021
- Lead Sponsor
- Gilead Sciences
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 261
- 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/Exclusion criteria may apply.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Idelalisib+ofatumumab Idelalisib 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. Ofatumumab 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. Idelalisib+ofatumumab 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.
- Primary Outcome Measures
Name Time Method Progression-Free Survival Randomization to End of Study (up to 60 months) 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.
- Secondary Outcome Measures
Name Time Method Lymph Node Response Rate Randomization to End of Study (up to 60 months) 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.
Complete Response Rate Randomization to End of Study (up to 60 months) 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).
Overall Response Rate Randomization to End of Study (up to 60 months) 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.Overall Survival Randomization to Last Long-Term Follow-Up Visit (up to maximum of 5 years) Overall survival was defined as the interval from randomization to death from any cause. Overall survival was analyzed using KM estimates.
Progression-Free Survival in Subgroup of Participants With Chromosome 17p Deletion and/or TP53 Mutation Randomization to End of Study (up to 60 months) Progression-free survival in subgroup of participants with chromosome 17p deletion and/or TP53 mutation was analyzed using KM estimates.
Trial Locations
- Locations (78)
Saint Mary's Regional Cancer Center
🇺🇸Grand Junction, Colorado, United States
Northwest Medical Specialties
🇺🇸Tacoma, Washington, United States
City of Hope
🇺🇸Duarte, California, United States
Haematology and Oncology Clinics of Australia at Mater
🇦🇺Milton, Queensland, Australia
Kaiser Permanente of Colorado
🇺🇸Denver, Colorado, United States
Georgia Regents University
🇺🇸Augusta, Georgia, United States
Weill Cornell Medical Center
🇺🇸New York, New York, United States
Coastal Integrative Cancer Care
🇺🇸San Luis Obispo, California, United States
Montgomery Cancer Center
🇺🇸Mount Sterling, Kentucky, United States
Universitair Ziekenhuis Gent
🇧🇪Ghent, Belgium
Centre Hospitalier Universitaire Hôpital Avicenne
🇫🇷Ile-de-france, France
Hospital Clínic i Provincial
🇪🇸Barcelona, Spain
Cancer Care Manitoba
🇨🇦Winnipeg, Canada
Saint George and Sutherland Hospitals
🇦🇺Kogarah, New South Wales, Australia
Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Centre Hospitalier Universitaire Nancy
🇫🇷Vandoeuvre, Limousin, Lorraine, France
Saint James's University Hospital
🇬🇧Leeds, United Kingdom
Center for Cancer and Blood Disorders, PC
🇺🇸Bethesda, Maryland, United States
Washington University Medical Center
🇺🇸Saint Louis, Missouri, United States
Karolinska University Hospital Solna
🇸🇪Stockholm, Sweden
Center Hospitalier Universitaire de Bordeaux
🇫🇷Pessac Cedex, Aquitaine, France
Centre Hospitalier de Perpignan
🇫🇷Perpignan, Languedoc-Roussillon, France
CHRU Clermont- Ferrand CHU Estaing
🇫🇷Auvergne, France
Department of Haematology, Cancer and Haematology Centre, Churchill Hospital (Oxford University Hospitals)
🇬🇧Oxford, United Kingdom
Queen Elizabeth Hospital
🇦🇺Woodville, Australia
Hopital Regional De Sudbury Regional Hospital (HRSRH) - Regional Cancer Program (RCP)
🇨🇦Sudbury, Ontario, Canada
Sunderby Sjukhus
🇸🇪Luleå, Sweden
Centre Hospitalier Universitaire Purpan
🇫🇷Toulouse Cedex, Midi-pyrenees, France
Hospital Morales Meseguer
🇪🇸Murcia, Spain
California Cancer Associates for Research and Excellence (CCARE)
🇺🇸Fresno, California, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Tenessee Oncology, PLLC
🇺🇸Nashville, Tennessee, United States
Kaiser Permanente Vallejo Medical Center
🇺🇸Vallejo, California, United States
Utah Cancer Specialists
🇺🇸Salt Lake City, Utah, United States
Saskatchewan Cancer Agency
🇨🇦Regina, Saskatchewan, Canada
Haematology and Transplant Unit
🇬🇧Manchester, England, United Kingdom
Kaiser Permanente
🇺🇸San Diego, California, United States
Cancer Specialists of North Florida
🇺🇸Jacksonville, Florida, United States
Oncology Hematology Care, Inc.
🇺🇸Cincinnati, Ohio, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Ashford Cancer Centre Research
🇦🇺Ashford, South Australia, Australia
Centre Hospitalier Universitaire de Montréal
🇨🇦Montréal, Quebec, Canada
Wojewódzki Szpital Specjalistyczny im. Janusza Kor
🇵🇱Slupsk, Pomorskie, Poland
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
Hospital Puerta de Hierro Majadahonda
🇪🇸Madrid, Spain
Aalborg Hospital
🇩🇰Aalborg, Denmark
Aarhus University Hospital
🇩🇰Århus, Denmark
Hôpital Saint Louis
🇫🇷Paris Cedex 10, Ile-de-france, France
Karolinska University Hospital Huddinge
🇸🇪Stockholm, Sweden
Frankston Hospital
🇦🇺Melbourne, Victoria, Australia
Collegium Medicum Uniwersytetu Jagiellonskiego w K
🇵🇱Kraków, Malopolskie, Poland
Norfolk and Norwich University Hospital
🇬🇧Norwich, Norfolk, United Kingdom
University College London
🇬🇧London, United Kingdom
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Tennessee Oncology, PLLC
🇺🇸Chattanooga, Tennessee, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Upstate Oncology Associates
🇺🇸Greenville, South Carolina, United States
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Ziekenhuis Netwerk Antwerpen
🇧🇪Antwerpen, Belgium
Cliniques Universitaires Saint Luc
🇧🇪Brussels, Belgium
Centralny Szpital Kliniczny MSW
🇵🇱Warszawa, Poland
Samodzielny Publiczny Szpital Kliniczny N1 Klinika
🇵🇱Wroclaw, Poland
Darent Valley Hospital
🇬🇧Dartford, England, United Kingdom
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
Universitaire Ziekenhuis Gasthuisberg
🇧🇪Leuven, Belgium
Birmingham Heartlands Hospital
🇬🇧Birmingham, England, United Kingdom
Royal Surrey County Hospital NHS Trust
🇬🇧Guildford, England, United Kingdom
University College Cork
🇮🇪Cork, Ireland
Szpital Specjalistyczny w Brzozowie
🇵🇱Brzozow, Poland
Centre Hospitalier Regional de Rimouski
🇨🇦Rimouski, Quebec, Canada
Saint James's Hospital
🇮🇪Dublin, Ireland
Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi
🇵🇱Lódz, Poland
Hospital Vall d´Hebrón
🇪🇸Barcelona, Spain
Royal Brisbane and Women's Hospital
🇦🇺Herston, Queensland, Australia
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Stanford University Medical Center
🇺🇸Stanford, California, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia