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Phase II Study of ONTAK in Previously Treated Patients With Low-grade Non-Hodgkin's Lymphoma (NHL)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: January 3, 2003
Last Update Posted: July 13, 2012
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.
Information provided by:
Eisai Inc.
The purpose of this study is to look at the safety and effectiveness of ONTAK in previously treated patients with NHL.

Condition Intervention Phase
Non-Hodgkin's Lymphoma Lymphoma, B-cell Lymphoma, Low-grade Drug: ONTAK Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Phase II Evaluation of ONTAK (Denileukin Diftitox) in Patients With Previously Treated, Indolent, B-Cell, Non-Hodgkin's Lymphoma

Resource links provided by NLM:

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Objective Clinical Response: Complete Response (CR) or Partial Response (PR) at Week 24, or, in the Event of Lengthened Cycle Intervals, at the End of Cycle 8. [ Time Frame: 24 Weeks ]
    Complete response: achievement of a complete regression for >4 weeks of all palpable and x-ray demonstrable disease and bone marrow disease. Partial response: response to therapy with a 75% reduction in the greatest diameters of the measurable lesions for >4 weeks and had indeterminate bone marrow biopsy

Secondary Outcome Measures:
  • Duration of Response [ Time Frame: From beginning of response to time of relapse ]
    The duration of response was defined as the time interval from start of the first response (CR or PR) to the time of documented disease progression.

  • Time-to-Treatment Failure [ Time Frame: From start of first treatment ]

Enrollment: 9
Study Start Date: May 2000
Study Completion Date: September 2006
Primary Completion Date: January 2001 (Final data collection date for primary outcome measure)

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Pathological diagnosis of low-grade (indolent), B-cell, non-Hodgkin's lymphoma.
  • Positive expression for CD25 of tumor cells in a lymph node biopsy as defined by greater than 20% of malignant cells staining for CD25 by standardized immunohistochemical assay.
  • Modified Ann Arbor Stage I, II, III or IV.
  • Patients must have received at least two but no more than five prior therapies. One prior therapy must have been cytotoxic chemotherapy and one prior therapy must have been monoclonal antibody therapy. Combination chemotherapy, including regimens used prior to bone marrow transplantation, will count as a single therapy for purposes of eligibility.
  • Patients must have bidimensionally measurable disease.
  • Patients must be 18 years of age or older.
  • An ECOG performance status of 0, 1, or 2.
  • Acceptable organ function defined as follows:

    • absolute neutrophil count (ANC) > or = to 1,000/mm3, platelet count > or = to 50,000/mm3, Hemoglobin > or = to 8 g/dL;
    • Bilirubin < or = to 1.5 times the upper limit of normal (ULN);
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < or = to 1.5 times the upper limit of normal;
    • Serum creatinine <1.8mg/dL;
    • Serum albumin > or = to 3.0 g/dL.
  • New York Heart Association classification of I or II and no history of poorly controlled hypertension.
  • Must be free of serious concurrent illness.
  • Female patients must meet the following criteria:

    • If the patient is a female of childbearing potential, she must have negative serum beta human chorionic gonadotropin (B-hCG) pregnancy test within seven days prior to study entry and must have used an effective means of contraception or have been sexually abstinent for at least four weeks prior to the negative serum pregnancy test and through to study entry.
    • Female patients of childbearing potential must agree to practice an effective method of birth control during the entire treatment period and for at least three weeks after their last treatment on protocol.

Exclusion Criteria:

  • Patients with cutaneous T-cell lymphoma.
  • Patients previously treated with ONTAK (DAB389lL-2) or DAB486IL-2.
  • Inability to comply with protocol requirements for this study.
  • Pregnant women or lactating women who are breast feeding or women planning to become pregnant during the treatment period or three weeks after their last treatment on protocol.
  • Serious intercurrent medical illnesses or active infections requiring parenteral antibiotics, which would interfere with the ability of the patient to carry out the treatment program.
  • Sero-positive for human immunodeficiency virus (HIV) antibody. History of ongoing Hepatitis B or Hepatitis C infection.
  • Another malignancy or history of another cancer with less than five disease-free years (other than resected basal or squamous cell skin cancers or in situ cervical cancer).
  • Patients with a known hypersensitivity to ONTAK or any of its components: diphtheria toxin, interleukin-2, or excipients.
  • Any investigational agents within one month prior to study entry.
  • Prior radiation therapy within four weeks of enrollment or to the only site of evaluable disease.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00051025

United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
United States, Louisiana
Hematology and Oncology Services
Metairie, Louisiana, United States, 70006
Sponsors and Collaborators
Eisai Inc.
Study Director: Elyane Lombardy, M.D. Ligand Pharmaceuticals
  More Information

ClinicalTrials.gov Identifier: NCT00051025     History of Changes
Obsolete Identifiers: NCT00005621
Other Study ID Numbers: L4389-30
First Submitted: December 31, 2002
First Posted: January 3, 2003
Results First Submitted: July 7, 2011
Results First Posted: August 3, 2011
Last Update Posted: July 13, 2012
Last Verified: July 2012

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