Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas
NCT ID: NCT01282424
Last Updated: 2019-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
125 participants
INTERVENTIONAL
2011-03-18
2018-05-16
Brief Summary
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Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg taken twice per day. Treatment with idelalisib can continue in compliant participants as long as the study is still ongoing and the participants appear to be benefiting from treatment with acceptable safety.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Idelalisib
Treatment with idelalisib will be continued until tumor progression or development of unacceptable toxicity.
Idelalisib
Idelalisib 150 mg tablet administered orally twice daily
Interventions
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Idelalisib
Idelalisib 150 mg tablet administered orally twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following:
* Follicular lymphoma (FL)
* Small lymphocytic lymphoma (SLL) with absolute lymphocyte count \< 5 x 10\^9/L at the time of diagnosis and on baseline laboratory assessment performed within 4 weeks prior to the start of study drug administration
* Lymphoplasmacytic lymphoma (LPL), with or without associated Waldenstroms Macroglobulinemia (WM)
* Marginal zone lymphoma (MZL) (splenic, nodal, or extranodal)
* Prior treatment with ≥ 2 prior chemotherapy-based or immunotherapy-based regimens for iNHL
* Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy
* Prior treatment with rituximab and with an alkylating agent (eg, bendamustine, cyclophosphamide, ifosfamide, chlorambucil, melphalan, busulfan, nitrosoureas) for iNHL
* Lymphoma that is refractory to rituximab and to an alkylating agent
* Discontinuation of all other therapies for treatment of iNHL ≥ 3 weeks before Visit 2
* For men and women of childbearing potential, willingness to abstain from sexual intercourse or employ an effective method of contraception during the study drug administration and follow-up periods
* Willingness and ability to provide written informed consent and to comply with the protocol requirements
Exclusion Criteria
* Known histological transformation from iNHL to diffuse large B-cell lymphoma
* History of a non-lymphoma malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, localized prostate cancer, other adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for ≥ 5 years
* Evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral upper respiratory tract infections) at the time of initiation of study treatment
* Pregnancy or breastfeeding
* Ongoing alcohol or drug addiction
* Known history of drug-induced liver injury, chronic active hepatitis B infection, chronic active hepatitis C infection, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver, or portal hypertension
* History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
* Ongoing immunosuppressive therapy, including systemic corticosteroids. Participant may be using topical or inhaled corticosteroids.
* Prior therapy with idelalisib
* Exposure to another investigational drug within 3 weeks prior to start of study treatment
* Concurrent participation in another therapeutic treatment trial
* Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, ECG finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participant, alter the absorption, distribution, metabolism or excretion of the study drug, or impair the assessment of study results
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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St. Jude Medical Center
Fullerton, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
UCLA
Los Angeles, California, United States
Central Coast Medical Oncology
Santa Maria, California, United States
Stanford Cancer Center
Stanford, California, United States
Collaborative Research Group, LLC
Boynton Beach, Florida, United States
Winship Cancer Institute
Atlanta, Georgia, United States
Northwestern University Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, United States
Washington University School of Medicine
St Louis, Missouri, United States
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, United States
University of Medicine and Dentistry of NJ
New Brunswick, New Jersey, United States
Weill Cornell -New York Presbyterian Hospital
New York, New York, United States
Montefiore Medical Center
New York, New York, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
South Carolina Oncology Associates
Columbia, South Carolina, United States
Chattanooga Hem/Oncology Ass (SCRI)
Chattanooga, Tennessee, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Charles A. Sammons Cancer Center
Dallas, Texas, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
CHU Morvan
Brest, , France
Centre Hospitalier de Lyon Sud
Pierre-Bénite, , France
Centre Henri Bequerel
Rouen, , France
CHU Bretonneau - Centre Kaplan
Tours, , France
Charité Campus Virchow Klinikum
Berlin, , Germany
Universitätsklinikum Essen
Essen, , Germany
Klinikum der Universität München-Großhadern
München, , Germany
Universitatsklinikum Ulm
Ulm, , Germany
Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi
Bologna, , Italy
A.O.U. San Martino
Genova, , Italy
Fondazione Centro San Raffaele del Monte Tabor
Milan, , Italy
Università "Sapienza"
Rome, , Italy
Małopolskie Centrum Medyczne
Krakow, , Poland
Centrum Onkologii w Warszawie
Warsaw, , Poland
St James's Institute of Oncology
Leeds, , United Kingdom
St Bartholemews Hospital
London, , United Kingdom
Sarah Cannon Institute
London, , United Kingdom
The Christie Hospital
Manchester, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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References
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Salles GA, Kahl, BS, Wagner-Johnston ND, et al. Interim results from a phase 2 study of PI3Kδ inhibitor idelalisib in patients with relapsed indolent non-Hodgki lymphoma (iNHL) refractory to both rituximab and an alkylating agent. 12th International Conference on Malignant Lymphoma, Palazzo dei Congressi, Lugano, Switzerland, June 19-22, 2013 Abstract No: 064bis.
Gopal AK, Kahl BS, de Vos S, Wagner-Johnston ND, Schuster SJ, Jurczak WJ, Flinn IW, Flowers CR, Martin P, Viardot A, Blum KA, Goy AH, Davies AJ, Zinzani PL, Dreyling M, Johnson D, Miller LL, Holes L, Li D, Dansey RD, Godfrey WR, Salles GA. PI3Kdelta inhibition by idelalisib in patients with relapsed indolent lymphoma. N Engl J Med. 2014 Mar 13;370(11):1008-18. doi: 10.1056/NEJMoa1314583. Epub 2014 Jan 22.
Ma S, Chan RJ, Gu L, Xing G, Rajakumaraswamy N, Ruzicka BB, Wagner-Johnston ND. Retrospective Analysis of the Impact of Adverse Event-Triggered Idelalisib Interruption and Dose Reduction on Clinical Outcomes in Patients With Relapsed/Refractory B-Cell Malignancies. Clin Lymphoma Myeloma Leuk. 2021 May;21(5):e432-e448. doi: 10.1016/j.clml.2020.12.016. Epub 2020 Dec 24.
Barrientos JC, Hillmen P, Salles G, Sharman J, Stilgenbauer S, Gurtovaya O, Xing G, Ruzicka B, Bhargava P, Ghia P, Pagel JM. No increased bleeding events in patients with relapsed chronic lymphocytic leukemia and indolent non-Hodgkin lymphoma treated with idelalisib. Leuk Lymphoma. 2021 Apr;62(4):837-845. doi: 10.1080/10428194.2020.1845339. Epub 2020 Dec 10.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol: Amendment 10 (Version 9.0)
Other Identifiers
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2010-022155-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
101-09
Identifier Type: -
Identifier Source: org_study_id