A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma
NCT ID: NCT01882803
Last Updated: 2023-09-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
129 participants
INTERVENTIONAL
2013-06-17
2020-11-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Participants With Indolent Non-Hodgkin Lymphoma
NCT04038359
Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas
NCT01282424
Study to Investigate Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 Monoclonal Antibody (mAb) in Participants With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia
NCT01088048
Study of Nivolumab in Patients With Classical Hodgkin's Lymphoma (Registrational)
NCT02181738
A Safety and Efficacy Study of Duvelisib in Relapsed/Refractory Follicular Lymphoma
NCT04707079
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Approximately 120 participants received 25 milligrams of duvelisib twice daily over the course of 28-day treatment cycles for up to 13 cycles.
After completing 13 treatment cycles of duvelisib, participants continued to receive additional cycles of duvelisib until disease progression or unacceptable toxicity. However, to receive additional cycles of duvelisib beyond 13 cycles, participants must have had evidence of response (complete response \[CR\] or partial response \[PR\]) or stable disease according to the International Working Group criteria by the end of Cycle 13.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Duvelisib
Duvelisib
Phosphoinositide-3-kinase (PI3K) inhibitor
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Duvelisib
Phosphoinositide-3-kinase (PI3K) inhibitor
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participants must have exhibited lack of CR or progressive disease (PR) or progression within 6 months after the last dose of a chemotherapy induction regimen or RIT.
* Participants must have had rituximab-refractory disease, defined as lack of CR or PR or PD within 6 months of last dose.
* Measurable disease with a lymph node or tumor mass ≥1.5 centimeters in at least one dimension by computed tomography (CT), positron emission tomography/CT or magnetic resonance imaging.
* Adequate renal and hepatic function.
Exclusion Criteria
* Previous treatment with a PI3K inhibitor or Bruton's tyrosine kinase inhibitor.
* Prior history of allogeneic hematopoietic stem cell transplant.
* Prior chemotherapy, cancer immunosuppressive therapy, or other investigational agents within 4 weeks before first dose of study drug.
* Grade 3B FL and/or clinical evidence of transformation to a more aggressive subtype of lymphoma.
* Symptomatic central nervous system NHL.
* Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment.
* Prior, current, or chronic hepatitis B or hepatitis C infection, positive result for hepatitis C virus antibodies, hepatitis B surface antigen, or hepatitis B core antibodies.
* History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to first dose of study drug.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
SecuraBio
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Los Angeles, California, United States
Whittier, California, United States
Denver, Colorado, United States
Fort Myers, Florida, United States
St. Petersburg, Florida, United States
Tallahassee, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Louisville, Kentucky, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
St Louis, Missouri, United States
Howell Township, New Jersey, United States
Morristown, New Jersey, United States
New York, New York, United States
Rockville Centre, New York, United States
Canton, Ohio, United States
Lawton, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Lynchburg, Virginia, United States
Lyasny, Minsk Oblast, Belarus
Brest, , Belarus
Minsk, , Belarus
Vitebsk, , Belarus
Ghent, , Belgium
Kortrijk, , Belgium
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Toronto, Ontario, Canada
Gatineau, Quebec, Canada
Montreal, Quebec, Canada
Brno, , Czechia
Ostrava-Poruba, , Czechia
Angers, , France
Bordeaux, , France
Clermont-Ferrand, , France
Marseille, , France
Pierre-Bénite, , France
Tbilisi, , Georgia
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Bologna, , Italy
Brescia, , Italy
Busto Arsizio, , Italy
Genova, , Italy
Meldola, , Italy
Milan, , Italy
Modena, , Italy
Orbassano, , Italy
Parma, , Italy
Ravenna, , Italy
Rimini, , Italy
Varese, , Italy
Barcelona, , Spain
Madrid, , Spain
Salamanca, , Spain
Cardiff, , United Kingdom
Chelsea, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Sutton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Flinn IW, Miller CB, Ardeshna KM, Tetreault S, Assouline SE, Mayer J, Merli M, Lunin SD, Pettitt AR, Nagy Z, Tournilhac O, Abou-Nassar KE, Crump M, Jacobsen ED, de Vos S, Kelly VM, Shi W, Steelman L, Le N, Weaver DT, Lustgarten S, Wagner-Johnston ND, Zinzani PL. DYNAMO: A Phase II Study of Duvelisib (IPI-145) in Patients With Refractory Indolent Non-Hodgkin Lymphoma. J Clin Oncol. 2019 Apr 10;37(11):912-922. doi: 10.1200/JCO.18.00915. Epub 2019 Feb 11.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013-004008-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IPI-145-06
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.