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Diagnosis of T cell non-Hodgkin lymphoma, T cell lymphomas included are peripheral T cell lymphoma not otherwise specified, angioimmunoblastic T cell lymphoma, and systemic anaplastic large cell lymphoma |
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Eligible for autologous stem cell transplantation as determined by the treating physician or completed autologous transplant within the last 30 days |
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At least 18 years of age at time of enrollment |
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Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 |
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Adequate organ function as defined below |
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Serum creatinine ≤ 1.5 times institutional upper limit of normal (IULN) |
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Total bilirubin ≤ 1.5 x IULN. Patients with Gilbert's Syndrome may have a bilirubin > 1.5 x IULN |
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Hemoglobin ≥ 8.0 g/dL |
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Absolute neutrophil count ≥ 1.0 x 109/L |
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Platelet count ≥ 75 x 109/L |
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AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN |
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Women of childbearing potential and men must agree to use highly effective |
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Participants or a participant's legally authorized representative must be able to understand and willing to sign an IRB approved written informed consent document |
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contraception prior to study entry and for the duration of study participation |
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and for 3 months after the last dose of duvelisib. Negative serum β human |
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chorionic gonadotropin (βHCG) pregnancy test within 7 days before first |
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treatment is required if the patient is a woman of childbearing potential |
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Currently receiving any other experimental therapy or has received experimental therapy within 4 weeks prior to study treatment
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History of allergic reaction attributed to compounds of similar chemical or biologic composition to duvelisib or other agents used in the study
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Prior history of drug-induced colitis or drug-induced pneumonitis
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History of concurrent interstitial lung disease or severely impaired lung function
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History of chronic liver disease or veno-occlusive disease
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History of tuberculosis within 2 years prior to enrollment
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Administration of a live or live attenuated vaccine within 6 weeks of first duvelisib dose
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Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids > 20 mg of prednisone (or equivalent) per day
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Ongoing treatment for systemic bacterial, fungal, or viral infections at screening
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Note: patients on antimicrobial, antifungal, or antiviral prophylaxis are not specifically
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excluded is all other inclusion/exclusion criteria are met
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Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV)
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or herpes zoster (VZV) at screening
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Infection with HBV, HCV. Subjects with a positive HBsAg or HCV Ab on pre-transplant
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infection screening will be excluded. Subjects with a positive HBcAb must have
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negative HBV DNA to be eligible and must be periodically monitored for HBV
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Pregnant or breastfeeding
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reactivation by institutional guidelines
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Baseline QTcF > 500 milliseconds. This does not apply to subjects with right or left
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bundle branch blocks
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Concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ
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of the cervix, bladder cancer, or prostate cancer not requiring treatment
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Clinically significant medical condition of malabsorption, inflammatory bowel disease
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chronic conditions which manifest with diarrhea, refractory nausea,vomiting, or any
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other condition that will interfere significantly with drug absorption
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Concurrent administration of medications or foods that are strong inhibitors or
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inducers of cytochrome P450 3A (CYP3A). No prior use within 2 weeks before the start
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of study intervention
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Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection (i.e., subjects
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with detectable viral load)
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History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia
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requiring medication or a pacemaker within the last 6 months prior to screening
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Uncontrolled intercurrent illness including, but not limited to, ongoing or active
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infection, symptomatic congestive heart failure, unstable angina pectoris, or unstable
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cardiac arrhythmia
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Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or
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they have a history of AIDS-defining opportunistic infection within the 12 months
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prior to registration. Concurrent treatment with effective ART according to DHHS
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treatment guidelines is recommended. Recommend exclusion of specific ART agents based
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on predicted drug-drug interactions (i.e. concurrent strong CYP3A4 inhibitors
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(ritonavir and cobicistat) or inducers (efavirenz) are contraindicated)
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