Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eisai Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Pathological diagnosis of peripheral T-cell lymphoma of one of the following histologies as per the REAL classification: peripheral T-cell lymphoma (unspecified), anaplastic large cell lymphoma CD30+, angioimmunoblastic T-cell lymphoma, nasal/nasal type T/NK cell lymphoma, intestinal T-cell lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitic T-cell lymphoma.
Treatment naïve except for prior radiation or a single cycle of CHOP.
Patients must have at least one clear-cut bidimensionally measurable site by physical exam and/or computed tomography.
Prior radiation therapy for localized disease is allowed as long as the irradiated area is not at the mediastinal area or at the only site of measurable disease. Therapy must be completed at least 4 weeks before the enrollment in study.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
At least 18 years of age.
Adequate bone marrow reserve, indicated by absolute neutrophil count (ANC) \> or equal to 1000/microL, platelets \> or equal to 50,000/microL (25,000/MicroL if thrombocytopenia secondary to bone marrow involvement by lymphoma), and hemoglobin \> or equal to 8 g/dL.
Adequate liver function, indicated by bilirubin \< or equal to 1.5 times the upper limit of normal (ULN), alanine transaminase (ALT) \< or equal to 2 times the ULN or aspartate transaminase (AST) \< or equal to 2.0 times the ULN, and albumin \> or equal to 3.0 g/dL.
Adequate renal function, indicated by serum creatinine \< or equal to 2.5 mg/dL.
Women of childbearing potential and sexually active males agree to use an accepted and effective method of contraception.
Able to give informed consent.
You may not be if
Diagnosis of Mycosis Fungoides or Sezary Syndrome.
Active Hepatitis B or Hepatitis C infection.
Known HIV infection (HIV testing is not required).
Previous doxorubicin therapy with cumulative dose of \>100 mg/m2.
Left Ventricular Ejection Fraction (LVEF) \< 50%.
Patients who are pregnant or breast-feeding.
Prior invasive malignancies within past 5 years.
Allergy to or history of allergy to diphtheria toxin or IL-2.
Preexisting severe cardiovascular disease (e.g. CHF, Severe CAD, cardiomyopathy, MI within the past 3 months, arrhythmia) requiring ongoing treatment.
Ongoing antineoplastic chemotherapy, radiation, hormonal (excluding contraceptives) or immunotherapy, or investigational medications within past 30 days.
Patients with deep vein thrombosis within 3 months.
Clareo Health | A Study of ONTAK and CHOP in Newly Diagnosed, Peripheral T-Cell Lymphoma
