A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Participants With Indolent Non-Hodgkin Lymphoma
Completed · Phase 2
Conditions studied: Indolent Non-Hodgkin Lymphoma
In brief
This study examined the effects of predefined 2-week duvelisib dose holidays on tumor responses and safety/tolerability.
Key facts
- Study ID
- NCT04038359
- Run by
- SecuraBio
- People needed
- 103
- Starts
- 2019-09-24
- Expected to finish
- 2023-07-24
- Last updated by the study team
- 2024-09-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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