This trial is active, not recruiting.

Condition lymphoma, t-cell, peripheral
Treatment ontak (denileukin diftitox, dab389 il-2)
Phase phase 2
Sponsor Eisai Inc.
Start date March 2004
End date August 2008
Trial size 50 participants
Trial identifier NCT00211185, #35


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
ontak (denileukin diftitox, dab389 il-2)
Ontak + CHOP every 3 weeks.

Primary Outcomes

Safety of the combination of ONTAK + CHOP is assessed every 3 weeks for 18 weeks using measures such as ECG, physical exam, weight and performance status, vital signs, and blood chemistry/hematology (every 6 weeks).
time frame: Every 3 weeks or as needed.

Secondary Outcomes

The response rate for the combination is assessed every 6 weeks using measures such as radiological tests for measurable disease and tumor measurements.
time frame: Every 6 weeks.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Additional Information

Official title A Pilot Phase II Study to Determine the Safety and Efficacy of the Combination of ONTAK With CHOP in Peripheral T-Cell Lymphoma.
Trial information was received from ClinicalTrials.gov and was last updated in August 2009.
Information provided to ClinicalTrials.gov by Eisai Inc..