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A Pilot Phase II Study to Determine the Safety and Efficacy of the Combination of ONTAK With CHOP in Peripheral T-Cell Lymphoma.

Phase 2
18 Years
Open (Enrolling)
Lymphoma, T-Cell, Peripheral

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Trial Information

A Pilot Phase II Study to Determine the Safety and Efficacy of the Combination of ONTAK With CHOP in Peripheral T-Cell Lymphoma.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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).

Outcome Time Frame:

Every 3 weeks or as needed.

Safety Issue:


Principal Investigator

Francine Foss, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Yale University


United States: Institutional Review Board

Study ID:




Start Date:

March 2004

Completion Date:

Related Keywords:

  • Lymphoma, T-Cell, Peripheral
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral



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