Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas
DELTA
A Phase 2 Study to Assess the Efficacy and Safety of Idelalisib in Subjects With Indolent B-Cell Non-Hodgkin Lymphomas Refractory to Rituximab and Alkylating Agents
2 other identifiers
interventional
125
6 countries
41
Brief Summary
The primary objective will be to assess the overall response rate and to evaluate the efficacy and safety of idelalisib (IDELA; GS-1101) in participants with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2011
Longer than P75 for phase_2
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2011
CompletedFirst Posted
Study publicly available on registry
January 25, 2011
CompletedStudy Start
First participant enrolled
March 18, 2011
CompletedResults Posted
Study results publicly available
September 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2018
CompletedJuly 11, 2019
June 1, 2019
7.1 years
January 21, 2011
August 22, 2014
June 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate
Overall response rate (ORR) was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the percentage of participants achieving a complete response (CR) or partial response (PR; or minor response \[MR\] for participants with WM) as assessed by the study independent review committee (IRC). CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions. For WM only, response was defined as a reduction in immunoglobulin M (IgM) of ≥ 50% decrease for PR, and ≥ 25% decrease for MR; no increase from baseline in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions or signs and symptoms of active disease (Owen, 2013)
Start of Treatment to End of Treatment (up to 81 months)
Secondary Outcomes (14)
Duration of Response
Start of Treatment to End of Treatment (up to 81 months)
Lymph Node Response Rate
Start of Treatment to End of Treatment (up to 81 months)
Time to Response
Start of Treatment to End of Treatment (up to 81 months)
Progression-Free Survival
Start of Treatment to End of Treatment (up to 81 months)
Overall Survival
Start of Treatment to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
- +9 more secondary outcomes
Study Arms (1)
Idelalisib
EXPERIMENTALTreatment with idelalisib will be continued until tumor progression or development of unacceptable toxicity.
Interventions
Idelalisib 150 mg tablet administered orally twice daily
Eligibility Criteria
You may qualify if:
- Karnofsky performance status of ≥ 60 (Eastern Cooperative Oncology Group \[ECOG\] performance score of 0, 1, or 2)
- 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
You may not qualify if:
- Central nervous system or leptomeningeal lymphoma
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (41)
St. Jude Medical Center
Fullerton, California, 92835, United States
Pacific Shores Medical Group
Long Beach, California, 90813-3244, United States
UCLA
Los Angeles, California, 90095, United States
Central Coast Medical Oncology
Santa Maria, California, 93454, United States
Stanford Cancer Center
Stanford, California, 94035-5796, United States
Collaborative Research Group, LLC
Boynton Beach, Florida, 33435, United States
Winship Cancer Institute
Atlanta, Georgia, 30322-1013, United States
Northwestern University Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
University of Medicine and Dentistry of NJ
New Brunswick, New Jersey, 08901-1914, United States
Weill Cornell -New York Presbyterian Hospital
New York, New York, 10002, United States
Montefiore Medical Center
New York, New York, 10467, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
South Carolina Oncology Associates
Columbia, South Carolina, 29210, United States
Chattanooga Hem/Oncology Ass (SCRI)
Chattanooga, Tennessee, 37404, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
University of Wisconsin
Madison, Wisconsin, 53792-5156, United States
CHU Morvan
Brest, 29609, France
Centre Hospitalier de Lyon Sud
Pierre-Bénite, 69310, France
Centre Henri Bequerel
Rouen, 76038, France
CHU Bretonneau - Centre Kaplan
Tours, 37044, France
Charité Campus Virchow Klinikum
Berlin, 13353, Germany
Universitätsklinikum Essen
Essen, 45147, Germany
Klinikum der Universität München-Großhadern
München, 81377, Germany
Universitatsklinikum Ulm
Ulm, 89081, Germany
Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi
Bologna, 40138, Italy
A.O.U. San Martino
Genova, 16132, Italy
Fondazione Centro San Raffaele del Monte Tabor
Milan, 20132, Italy
Università "Sapienza"
Rome, 00161, Italy
Małopolskie Centrum Medyczne
Krakow, 30-510, Poland
Centrum Onkologii w Warszawie
Warsaw, 02-781, Poland
St James's Institute of Oncology
Leeds, LS9 7TF, United Kingdom
St Bartholemews Hospital
London, EC1M 6BQ, United Kingdom
Sarah Cannon Institute
London, W1G 6AD, United Kingdom
The Christie Hospital
Manchester, M20 4BX, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Related Publications (4)
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.
RESULTGopal 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.
PMID: 24450858RESULTMa 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.
PMID: 33516721DERIVEDBarrientos 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.
PMID: 33297794DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2011
First Posted
January 25, 2011
Study Start
March 18, 2011
Primary Completion
May 2, 2018
Study Completion
May 16, 2018
Last Updated
July 11, 2019
Results First Posted
September 4, 2014
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
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.