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

NCT ID: NCT04038359

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-24
• Study Completion Date: 2023-07-24

Brief Summary

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

Detailed Description

This was a Phase 2, randomized, open-label, 2-arm study designed to evaluate the efficacy and safety of prescribed drug holidays of duvelisib treatment in participants with relapsed or refractory (R/R) indolent non-Hodgkin lymphoma (iNHL) who have received at least 1 prior systemic therapy.

Conditions

Indolent Non-Hodgkin Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Duvelisib, Continuous and Intermittent Dosing

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.

Group Type: EXPERIMENTAL

Duvelisib

Intervention Type: DRUG

Phosphoinositide 3-kinase (PI3K) inhibitor

Duvelisib, Intermittent Dosing

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

Group Type: EXPERIMENTAL

Duvelisib

Intervention Type: DRUG

Phosphoinositide 3-kinase (PI3K) inhibitor

Interventions

Duvelisib

Phosphoinositide 3-kinase (PI3K) inhibitor

Intervention Type: DRUG

Other Intervention Names

Copiktra; VS-0145; IPI-145

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SecuraBio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Florida Cancer Specialists - Fort Myers

Fort Myers, Florida, United States

Florida Cancer Specialists & Research Institute - Lecanto

Lecanto, Florida, United States

Mid-Florida Cancer Centers

Orange City, Florida, United States

Robert H. Lurie Comprehensive Cancer Center

Chicago, Illinois, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Tennessee Oncology

Nashville, Tennessee, United States

FN Hradec Kralove

Hradec Králové, , Czechia

Vseobecna fakultni nemocnice v Praze

Prague, , Czechia

Universitaetsklinikum Bonn AöR

Bonn, , Germany

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

Meldola, Forli, Italy

IEO - Istituto Europeo di Oncologia, IRCCS

Milan, , Italy

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

Reggio Emilia, , Italy

Azienda Ospedaliera Santa Maria di Terni

Terni, , Italy

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

Varese, , Italy

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

Słupsk, Pomeranian Voivodeship, Poland

Pratia Onkologia Katowice

Katowice, , Poland

Centrum Medyczne Pratia Poznan

Skórzewo, , Poland

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

Moscow, , Russia

City Clinical Hospital n.a. Botkin

Moscow, , Russia

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

Saint Petersburg, , Russia

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Asan Medical Center - Oncology

Seoul, , South Korea

Samsung Medical Center - Hematology-Oncology

Seoul, , South Korea

NHS Greater Glasgow & Clyde - CRUK Clinical Trials Unit

Glasgow, , United Kingdom

Royal Liverpool Hospital [Hematology/Transfusion Medicine]

Liverpool, , United Kingdom

Christie Hospital NHS Foundation Trust

Manchester, , United Kingdom

Countries

United States; Czechia; Germany; Italy; Poland; Russia; South Korea; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2019-001381-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VS-0145-229

Identifier Type: -

Identifier Source: org_study_id