Non Hodgkin Lymphoma Clinical Trial
A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects With Indolent Non-Hodgkin Lymphoma. (TEMPO)
This study will examine the effects of predefined 2 week duvelisib dose holidays on tumor responses and safety/tolerability.
This is a Phase 2, randomized, open-label, 2 arm study designed to evaluate the efficacy and safety of prescribed drug holidays of duvelisib treatment in subjects with R/R iNHL who have received at least 1 prior systemic therapy.
Age ≥ 18 years, ECOG performance status ≤ 2
Histologically confirmed diagnosis of iNHL (Subtypes include FL Grades 1 to 3a, marginal zone lymphoma (splenic, nodal, or extranodal), or SLL
Must have received 1 prior systemic regimen for iNHL
Must have documented radiologic evidence of disease progression, and at least 1 bi-dimensionally measurable lesion ≥ 1.5 cm (which has not been previously irradiated), according to 2007 revised IWG criteria
Must have adequate organ function defined by the following laboratory parameters:
Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L
Platelet count ≥ 75 × 10^9/L
Serum creatinine < 2.0 mg/dL (197 µmol/L)
Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (exception: subjects with Gilbert's Syndrome may have a bilirubin > 1.5 × ULN)
Aspartate transaminase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum pyruvic transaminase (SGPT) ≤ 3.0 × ULN
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 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 CLL
Prior allogeneic hematopoietic stem cell transplant (HSCT); treatment with a PI3K inhibitor
History of drug-induced colitis or pneumonitis; TB 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 (CMV) or Epstein-Barr virus (EBV) infection
Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening
Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 3A (CYP3A). No prior use within 2 weeks before the start of study intervention.
Baseline QTcF > 500 ms
Concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix, bladder cancer, or prostate cancer not requiring treatment. Subjects 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 subject's risk to participating in this study.
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There are 40 Locations for this study
Washington District of Columbia, 20052, United States
Fort Myers Florida, 33901, United States
Lecanto Florida, 34461, United States
Orange City Florida, 32763, United States
Tallahassee Florida, 32308, United States
West Palm Beach Florida, 33401, United States
Chicago Illinois, 60611, United States
Baltimore Maryland, 21229, United States
Kansas City Missouri, 64132, United States
Omaha Nebraska, 68114, United States
Las Vegas Nevada, 89169, United States
Charlotte North Carolina, 28204, United States
Greenville South Carolina, 29615, United States
Nashville Tennessee, 37203, United States
Temple Texas, 76508, United States
Hradec Králové , 500 0, Czechia
Ostrava - Poruba , 708 5, Czechia
Praha 2 , 128 0, Czechia
Bielefeld , 33611, Germany
Meldola Forli, 47014, Italy
Bologna , 40138, Italy
Milano , 20132, Italy
Milano , 20141, Italy
Terni , 05100, Italy
Varese , 21100, Italy
Seongnam-si , 13620, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Seoul , 08308, Korea, Republic of
Slupsk Pomorskie, 76-20, Poland
Chorzów , 41-50, Poland
Lublin , 20-60, Poland
Skórzewo , 60-18, Poland
Moscow , 12528, Russian Federation
Sankt-Peterburg , 19429, Russian Federation
Glasgow , G12 0, United Kingdom
Manchester , M20 4, United Kingdom
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