A Study of ONTAK and CHOP in Newly Diagnosed, Peripheral T-Cell Lymphoma
Condition: Lymphoma, T-Cell, Peripheral
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Intervention: Denileukin diftitox; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone; Pegfilgrastim
Intervention description: Denileukin diftitox will be administered intravenously (IV) at a dosage of 18 micrograms/kilogram/day (ug/kg/d) on Days 1 and 2 of each 21-Day cycle for a total of 6 cycles, with a maximum of 8 cycles.; Cyclophosphamide will be administered IV at a dosage of 750 milligrams/meter squared (mg/m^2) on Day 3 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.; Doxorubicin will be administered IV at a dosage of 50 mg/m^2 on Day 3 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.; Vincristine will be administered IV at a dosage of 1.4 mg/m^2 on Day 3 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.; Prednisone will be administered orally at a dosage of 100 mg on Days 3 to 7 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.; Pegfilgrastim will be administered at a dosage of 6 mg subcutaneously on Day 4 to help prevent neutropenia. Alternatively, participants received filgrastim 5 ug/kg/d starting on Day 4 and continued until absolute neutrophil count (ANC) was less than 5000/millimeter squared (mm^2) for 2 days post-nadir.
Intervention MeSH terms: Prednisone; Cyclophosphamide; Doxorubicin; Vincristine; Denileukin diftitox; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.