A Study of ONTAK and CHOP in Newly Diagnosed, Peripheral T-Cell Lymphoma

Completed · Phase 2

Conditions studied: Lymphoma, T-Cell, Peripheral

In brief

Study of ONTAK and CHOP (chemotherapy drugs) to find out their ability to make Peripheral T-cell lymphoma disappear (for any period of time) and potentially lengthen life. The study will also compare what kind of side effects these drugs cause and how often they occur. The hypothesis is that patients with newly diagnosed peripheral T-Cell lymphoma, when given ONTAK + CHOP, will tolerate the treatment and will have a 20% improvement in response rate when compared to CHOP alone.

Key facts

Study ID

NCT00211185

Run by

Eisai Inc.

People needed

49

Starts

2004-03-14

Expected to finish

2009-12-23

Last updated by the study team

2020-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify if…

• Diagnosis of Mycosis Fungoides or Sezary Syndrome.
• Active Hepatitis B or Hepatitis C infection.
• Known HIV infection (HIV testing is not required).
• Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections have resolved and any continuing treatment if appropriate is given on an outpatient basis.
• 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.

Where it is running

• Birmingham Hematology and Oncology — Birmingham, Alabama, United States
• Hematology Oncology Associates — Phoenix, Arizona, United States
• Stanford Cancer Center — Stanford, California, United States
• Rocky Mountain Cancer Center — Denver, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Ocala Oncology Center — Ocala, Florida, United States
• Cancer Centers of Florida, P.A. — Ocoee, Florida, United States
• Hematology Oncology Associates of IL — Chicago, Illinois, United States
• Robert H. Lurie Comprehensive Cancer Center — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Cancer Care & Hematology Specialists of Chicagoland — Niles, Illinois, United States
• Siouxland Hematology Oncology — Sioux City, Iowa, United States
• Kansas City Cancer Centers — Lenexa, Kansas, United States
• Dana Farber/ Harvard Cancer Center — Boston, Massachusetts, United States
• New England Medical Center — Boston, Massachusetts, United States
• Minnesota Oncology Hematology, P.A. — Minneapolis, Minnesota, United States
• Missouri Cancer Associates — Columbia, Missouri, United States
• Kansas City Cancer Centers — Kansas City, Missouri, United States
• St. Joseph Oncology Inc. — Saint Joseph, Missouri, United States
• Arch Medical Services — St Louis, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Hematology Oncology Associates of NNJ — Morristown, New Jersey, United States
• New Mexico Cancer Care Associates — Santa Fe, New Mexico, United States
• New York Oncology Hematology, P.C. — Albany, New York, United States
• Raleigh Hematology Oncology Associates — Cary, North Carolina, United States

Full record on ClinicalTrials.gov

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