A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma

NCT01882803 | Completed Phase 2 Results DMC

• 2 other identifiers: IPI-145-062013-004008-20
• Study Type: interventional
• Target: 129
• Locations: 11 countries
• Sites: 65

Brief Summary

This was a Phase 2 clinical trial to evaluate the safety and efficacy of duvelisib as a monotherapy in participants with indolent non-Hodgkin lymphoma (iNHL) (follicular lymphoma \[FL\], marginal zone lymphoma, or small lymphocytic lymphoma) that was refractory to rituximab and to either chemotherapy or radioimmunotherapy (RIT).

Conditions

Indolent Non-Hodgkin Lymphoma

Keywords

PI3K Inhibitor

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR, defined as the total percentage of participants who had a best overall response of either complete response (CR) or partial response (PR), was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma. ORR is reported with a 2-sided 95% exact confidence interval.

  Every 8-16 weeks while on treatment with duvelisib for up to 72 months

Secondary Outcomes (6)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Every 2-8 weeks for up to 73 months

• Duration of Response (DOR)

  Every 8-16 weeks for up to 72 months

• Progression-free Survival (PFS)

  Every 8-16 weeks for up to 72 months

• Overall Survival (OS)

  Every 16 weeks for up to 72 months

• Plasma Concentration of Duvelisib and IPI-656

  Every 4 weeks for 12 weeks (C1D15: predose, 1 and 4 hours post dose; C2D1 and C3D1: anytime during study visit)

Study Arms (1)

Duvelisib

EXPERIMENTAL

Drug: Duvelisib

Interventions

Duvelisib DRUG

Phosphoinositide-3-kinase (PI3K) inhibitor

Also known as: Copiktra, IPI-145

Duvelisib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who had been diagnosed with iNHL that had progressed.
• 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.

You may not qualify if:

• Candidate for potentially curative therapies in the opinion of the investigator.
• 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.

Sponsors & Collaborators

• SecuraBio: lead

Study Sites (69)

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Los Angeles, California, 90095-6984, United States

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Whittier, California, 90603, United States

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Denver, Colorado, 80218, United States

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Fort Myers, Florida, 39916, United States

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St. Petersburg, Florida, 33705, United States

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Tallahassee, Florida, 32308, United States

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Atlanta, Georgia, 30322, United States

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Chicago, Illinois, 60637, United States

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Louisville, Kentucky, 40207, United States

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Baltimore, Maryland, 21204, United States

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Baltimore, Maryland, 21229, United States

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Boston, Massachusetts, 02215, United States

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St Louis, Missouri, 63110, United States

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Howell Township, New Jersey, 07731, United States

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Morristown, New Jersey, 07962, United States

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New York, New York, 10021, United States

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Rockville Centre, New York, 11510, United States

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Canton, Ohio, 44718, United States

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Lawton, Oklahoma, 73505, United States

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Oklahoma City, Oklahoma, 73104, United States

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Philadelphia, Pennsylvania, 01911, United States

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Nashville, Tennessee, 37203, United States

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Dallas, Texas, 75246, United States

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Lynchburg, Virginia, 24501, United States

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Lyasny, Minsk Oblast, 223040, Belarus

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Brest, 224027, Belarus

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Minsk, 220013, Belarus

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Vitebsk, 210603, Belarus

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Ghent, 9000, Belgium

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Kortrijk, 8500, Belgium

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Sofia, 1233, Bulgaria

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Sofia, 1407, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1756, Bulgaria

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Toronto, Ontario, M5G 2M9, Canada

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Gatineau, Quebec, J8P7H2, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Brno, 625-00, Czechia

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Ostrava-Poruba, 708-52, Czechia

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Angers, 49933, France

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Bordeaux, 33076, France

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Clermont-Ferrand, 63000, France

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Marseille, 13005, France

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Pierre-Bénite, 69495, France

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Tbilisi, 0186, Georgia

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Budapest, 1083, Hungary

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Budapest, 1122, Hungary

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Debrecen, 4032, Hungary

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Bologna, 40138, Italy

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Brescia, 25123, Italy

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Busto Arsizio, 21052, Italy

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Genova, 16132, Italy

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Meldola, 47014, Italy

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Milan, 20162, Italy

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Modena, 41124, Italy

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Orbassano, 10043, Italy

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Parma, 43100, Italy

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Ravenna, 48121, Italy

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Rimini, 47923, Italy

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Varese, 21100, Italy

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Barcelona, 08036, Spain

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Madrid, 28222, Spain

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Salamanca, 37007, Spain

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Cardiff, CF 14 4XW, United Kingdom

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Chelsea, United Kingdom

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Liverpool, L7 8XP, United Kingdom

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London, NW1 2PG, United Kingdom

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London, W1G 6AD, United Kingdom

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Sutton, SM2 5PT, United Kingdom

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Related Publications (1)

• 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.

  PMID: 30742566 DERIVED

MeSH Terms

Interventions

duvelisib

Results Point of Contact

• Title: Beth Gregory, PharmD, MBA
• Organization: Secura Bio, Inc.

bgregory@securabio.com

1-702-254-0011

Publication Agreements

• PI is Sponsor Employee: No
• 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: May 31, 2013
• First Posted: June 20, 2013
• Study Start: June 17, 2013
• Primary Completion: November 18, 2020
• Study Completion: November 18, 2020
• Last Updated: September 7, 2023
• Results First Posted: November 20, 2018

Record last verified: 2023-09

Locations

BU (4); HU (3); ES (3); IT (12); US (24); CA (3); CZ (2); BE (2); GE (1); GB (6); FR (5)