A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Participants With Indolent Non-Hodgkin Lymphoma

NCT04038359 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: VS-0145-2292019-001381-14
• Study Type: interventional
• Target: 103
• Locations: 8 countries
• Sites: 28

Brief Summary

This study examined the effects of predefined 2-week duvelisib dose holidays on tumor responses and safety/tolerability.

Conditions

Indolent Non-Hodgkin Lymphoma

Keywords

PI3K Inhibitor

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR) According to the 2007 Revised International Working Group (IWG) Criteria

  ORR was defined as the percentage of participants achieving a complete response (CR) or partial response (PR) and assessed using the 2007 revised IWG criteria. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites.

  Up to 14 months

Secondary Outcomes (8)

• Progression-free Survival (PFS)

  Up to 2 years

• ORR At Specific Timepoints

  6, 12, 18, and 24 months after first dose of study intervention

• Duration of Response (DOR)

  Up to 2 years

• Overall Survival (OS)

  Up to 2 years

• Lymph Node Response Rate (LNRR)

  14 months

Study Arms (2)

Duvelisib, Continuous and Intermittent Dosing

EXPERIMENTAL

Duvelisib 25 milligrams (mg) twice daily (BID) continuously for 10 weeks, followed by 25 mg BID dosed 2 weeks off and 2 weeks on for each subsequent 4-week cycle.

Drug: Duvelisib

Duvelisib, Intermittent Dosing

EXPERIMENTAL

Duvelisib 25 mg BID dosed 2 weeks on and 2 weeks off.

Drug: Duvelisib

Interventions

Duvelisib DRUG

Phosphoinositide 3-kinase (PI3K) inhibitor

Also known as: Copiktra, VS-0145, IPI-145

Duvelisib, Continuous and Intermittent Dosing; Duvelisib, Intermittent Dosing

Eligibility Criteria

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

You may qualify if:

• Eastern Cooperative Oncology Group performance status ≤ 2
• Histologically confirmed diagnosis of iNHL (subtypes include follicular lymphoma \[FL\] Grades 1 to 3a), marginal zone lymphoma (splenic, nodal, or extranodal), or small lymphocytic lymphoma
• Must have received 1 prior systemic regimen for iNHL
• Must have documented radiologic evidence of disease progression, at least 1 bi-dimensionally measurable lesion ≥ 1.5 centimeters (which has not been previously irradiated), according to 2007 revised International Working Group criteria, and be a candidate for a subsequent line of therapy.
• Must have adequate organ function defined by the following laboratory parameters:
• Absolute neutrophil count ≥ 1.0 × 10\^9/liter (L)
• Platelet count ≥ 75 × 10\^9/L
• Hemoglobin ≥ 8 grams/deciliter
• Estimated creatinine clearance ≥ 60 milliliters/minute, as determined by the Cockcroft-Gault method
• Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (exception: participants with Gilbert's Syndrome may have a bilirubin \> 1.5 × ULN)
• Aspartate transaminase/serum glutamic-oxaloacetic transaminase and alanine aminotransferase/serum pyruvic transaminase ≤ 3.0 × ULN

You may not qualify if:

• Anticancer treatment, major surgery, or use of any investigational drug within 28 days before the start of study intervention; palliative radiation therapy is allowed if \> 7 days before planned first dose of study interventions, and any toxicity is Grade ≤ 1
• Clinical or histological evidence of transformation to a more aggressive subtype of lymphoma or grade 3b FL or Richters' transformation or chronic lymphocytic leukemia
• Prior allogeneic hematopoietic stem cell transplant; prior treatment with a PI3K inhibitor
• History of drug-induced colitis or pneumonitis; tuberculosis treatment ≤ 2 years prior to randomization; administration of a live or live attenuated vaccine within 6 weeks of randomization
• Ongoing treatment with chronic immunosuppressants or systemic steroids or treatment for systemic bacterial, fungal, or viral infection
• Active cytomegalovirus or Epstein-Barr virus infection
• Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus, or herpes zoster at screening
• Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 3A. No prior use within 2 weeks before the start of study intervention.
• Baseline QT interval corrected with Fridericia's method \> 500 milliseconds
• Concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix, bladder cancer, or prostate cancer not requiring treatment. Participants with previous malignancies are eligible if they have been disease-free for 2 years or more.
• Unstable or severe uncontrolled medical condition that would, in the Investigator's judgment, increase the participant's risk to participating in this study.

Sponsors & Collaborators

• SecuraBio: lead

Study Sites (28)

Florida Cancer Specialists - Fort Myers

Fort Myers, Florida, 33901, United States

Location

Florida Cancer Specialists & Research Institute - Lecanto

Lecanto, Florida, 34461, United States

Location

Mid-Florida Cancer Centers

Orange City, Florida, 32763, United States

Location

Robert H. Lurie Comprehensive Cancer Center

Chicago, Illinois, 60611, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

FN Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

Vseobecna fakultni nemocnice v Praze

Prague, 128 08, Czechia

Location

Universitaetsklinikum Bonn AöR

Bonn, 53127, Germany

Location

Oncology Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori

Meldola, Forli, 47014, Italy

Location

IEO - Istituto Europeo di Oncologia, IRCCS

Milan, 20141, Italy

Location

AUSL di Reggio Emilia IRCCS, Arcispedale Santa Maria Nuova di Reggio Emilia

Reggio Emilia, 42123, Italy

Location

Azienda Ospedaliera Santa Maria di Terni

Terni, 05100, Italy

Location

Ospedale di Circolo, PO Varese, AO Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

Location

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.

Słupsk, Pomeranian Voivodeship, 76-200, Poland

Location

Pratia Onkologia Katowice

Katowice, 40-519, Poland

Location

Centrum Medyczne Pratia Poznan

Skórzewo, 60-185, Poland

Location

State Budgetary Healthcare Institution of Moscow City Moscow Multidisciplinary Clinical Center "Kommunarka" of the Department of Healthcare of Moscow City

Moscow, 108814, Russia

Location

City Clinical Hospital n.a. Botkin

Moscow, 125284, Russia

Location

First Saint-Petersburg State Medical University n.a. I.P. Pavlov

Saint Petersburg, 197022, Russia

Location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center - Oncology

Seoul, 05505, South Korea

Location

Samsung Medical Center - Hematology-Oncology

Seoul, 06351, South Korea

Location

NHS Greater Glasgow & Clyde - CRUK Clinical Trials Unit

Glasgow, G12 0YN, United Kingdom

Location

Royal Liverpool Hospital [Hematology/Transfusion Medicine]

Liverpool, L7 8XP, United Kingdom

Location

Christie Hospital NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Interventions

duvelisib

Results Point of Contact

• Title: Ohad Bentur, MD, MHA, MSc
• Organization: Secura Bio, Inc.

obentur@securabio.com

1-702-254-0011

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 30, 2019
• Study Start: September 24, 2019
• Primary Completion: July 24, 2023
• Study Completion: July 24, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Locations

GB (3); PL (3); US (6); CZ (2); DE (1); RU (3); KR (5); IT (5)