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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.
First Received: December 31, 2002   Last Updated: April 15, 2009   History of Changes
Sponsored by: Eisai Medical Research Inc.
Information provided by: Eisai Medical Research Inc.
ClinicalTrials.gov Identifier: NCT00051025
  Purpose

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 II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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 Medical Research Inc.:

Primary Outcome Measures:
  • Objective clinical response (CR or PR) at Week 24, or, in the event of lengthened cycle intervals, at the end of Cycle 8.

Secondary Outcome Measures:
  • Duration of response.
  • Time-to-Treatment Failure

Estimated Enrollment: 64
Study Start Date: May 2000
Study Completion Date: September 2006
Primary Completion Date: January 2001 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

    • 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);
    • SGOT (AST) and SGPT (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-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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00051025

Locations
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 Medical Research Inc.
Investigators
Study Director: Elyane Lombardy, M.D. Ligand Pharmaceuticals
  More Information

No publications provided

Study ID Numbers: L4389-30
Study First Received: December 31, 2002
Last Updated: April 15, 2009
ClinicalTrials.gov Identifier: NCT00051025     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Lymphoma, Small Cleaved-cell, Diffuse
Lymphoma, B-Cell
Lymphatic Diseases
Immunoproliferative Disorders
B-cell Lymphomas
Denileukin diftitox
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

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

ClinicalTrials.gov processed this record on July 02, 2009