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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00211185
Recruitment Status : Unknown
Verified March 2008 by Eisai Inc..
Recruitment status was:  Active, not recruiting
First Posted : September 21, 2005
Last Update Posted : August 28, 2009
Information provided by:
Eisai Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Lymphoma, T-Cell, Peripheral Drug: ONTAK (denileukin diftitox, DAB389 IL-2) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : March 2004
Estimated Primary Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: 1 Drug: ONTAK (denileukin diftitox, DAB389 IL-2)
Ontak + CHOP every 3 weeks.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00211185

  Show 49 Study Locations
Sponsors and Collaborators
Eisai Inc.
Study Chair: Francine Foss, M.D. Yale University

Publications of Results:
Francine M. Foss, Nelida Sjak-Shie, Andre Goy, Ranjana Advani, Eric Jacobsen, and Mark Acosta A Phase II Study of Denileukin Diftitox (Ontak®) with CHOP Chemotherapy in Patients with Newly-Diagnosed Aggressive T-Cell Lymphomas, the CONCEPT Trial: Interim Analysis. Blood (ASH Annual Meeting Abstracts), Nov 2006; 108: 2461.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mark Acosta, Eisai Medical Research Inc. Identifier: NCT00211185     History of Changes
Other Study ID Numbers: #35
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: August 28, 2009
Last Verified: March 2008

Additional relevant MeSH terms:
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Denileukin diftitox
Antineoplastic Agents