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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Eisai Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00211185
First received: September 13, 2005
Last updated: August 27, 2009
Last verified: March 2008

September 13, 2005
August 27, 2009
March 2004
August 2008   (final data collection date for primary 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). [ Time Frame: Every 3 weeks or as needed. ] [ Designated as safety issue: Yes ]
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).
Complete list of historical versions of study NCT00211185 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
The response rate for the combination is assessed every 6 weeks using measures such as radiological tests for measurable disease and tumor measurements.
Not Provided
Not Provided
 
A Study of ONTAK and CHOP in Newly Diagnosed, Peripheral T-Cell Lymphoma
A Pilot Phase II Study to Determine the Safety and Efficacy of the Combination of ONTAK With CHOP in Peripheral T-Cell Lymphoma.

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma, T-Cell, Peripheral
Drug: ONTAK (denileukin diftitox, DAB389 IL-2)
Ontak + CHOP every 3 weeks.
Experimental: 1
Intervention: Drug: ONTAK (denileukin diftitox, DAB389 IL-2)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
Not Provided
August 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00211185
#35
Yes
Mark Acosta, Eisai Medical Research Inc.
Eisai Inc.
Not Provided
Study Chair: Francine Foss, M.D. Yale University
Eisai Inc.
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP