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A Study of ONTAK in Patients With Relapsed or Refractory, B-Cell Non Hodgkin's 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: NCT00211276
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : March 14, 2012
Information provided by:
Eisai Inc.

Brief Summary:
The goal of this clinical research study is to find out if the study drug, ONTAK (denileukin diftitox), can shrink or slow the growth of B-cell non-Hodgkin's lymphoma (NHL) in patients whose disease has not responded to prior treatments, or has relapsed after an initial response to prior treatments. The safety of treatment with ONTAK will also be studied. The hypothesis is that patients with relapsed or refractory B-cell NHL and mild to moderate myelosuppression treated with ONTAK at a new dosing regimen will respond sufficiently to warrant further study.

Condition or disease Intervention/treatment Phase
Lymphoma, B-Cell Drug: ONTAK (denileukin diftitox) Phase 2

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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 Phase II Multicenter Study of ONTAK in Patients With Relapsed or Refractory, B-Cell Non-Hodgkins Lymphoma.
Study Start Date : March 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Primary Outcome Measures :
  1. Disease Response will be evaluated by CT or MRI scans at baseline, every 8 weeks while on therapy, and every 3 months after therapy, using standard response criteria defined by Cheson et al.

Secondary Outcome Measures :
  1. Safety data will include laboratory, history and physical, and adverse events reports for both local and systemic signs or symptoms of study patients. Survival at one year post-therapy will also be assessed.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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:

  • Relapsed or refractory B-Cell NHL
  • Histological documentation of diffuse large B-cell lymphoma, follicular lymphoma (grade 1, 2, or 3), small lymphocytic lymphoma or transformed B-Cell lymphoma.
  • Bi-dimensionally measurable disease with at least one lymph node or tumor mass measuring > or equal to 4 cm2
  • ECOG performance status less than or equal to 2.
  • Failure to respond or progression of disease after 2 or more prior treatment regimens; this may include high dose therapy (HDT) with stem cell transplantation (SCT). Patients with prior HDT plus SCT will be considered as having "diminished bone marrow reserve"
  • At least 18 years of age
  • At least 3 weeks from last anti-lymphoma therapy
  • Mild to moderate cytopenia defined as any of the following:
  • ANC > or equal to 1,000/microL and < 1,500/microL off growth factors
  • WBC counts > or equal to 2,000/microL and < 4,000/microL off growth factors or
  • Platelet count > or equal to 40,000/microL (25,000/microL if thrombocytopenia is secondary to marrow involvement by lymphoma) and < 150,000/microL.
  • Acceptable organ function defined as all of the following:
  • Bilirubin < or equal to 1.5 times the upper limit of normal (ULN)
  • SGOT (AST) and SGPT (ALT) < or equal to 2 times the ULN.
  • Serum creatinine < 2 times ULN.
  • Serum albumin > or equal to 3.0 g/dL
  • Female patient of childbearing potential must have a negative pregnancy test within seven days prior to study drug administration, and must agree to use an effective means of contraception throughout the study.
  • Life expectancy of at least 16 weeks.
  • Patients must have reviewed, signed and dated a witnessed informed consent document that has been approved by the IRB of each participating center.

Exclusion Criteria:

  • Less than 6 months from prior allogeneic stem cell transplant and/or patient with active graft versus host disease (GVHD) Grade > or equal to 2.
  • Prior history of veno-occlusive disease of the liver.
  • Inability to comply with protocol requirements of this study for intravenous administration of ONTAK.
  • Pregnant women or lactating women who are breastfeeding or women planning to become pregnant during the treatment period.
  • Serious intercurrent medical illnesses or active infections that, in the investigators opinion, might interfere with the interpretation of the study safety data or compromise the patients ability to carry out the treatment program.
  • Known history of seropositivity for HIV or chronic hepatitis (testing for HIV is not required).
  • Known hypersensitivity to ONTAK or any of its components: diptheria toxin, interleukin-2 or excipients.
  • Experimental therapy within 4 weeks prior to study entry.
  • Patients diagnosed with congestive heart failure, NYHA Class III or IV, ventricular tachycardia, fibrillation, or a history of myocardial infarction in the 12 months prior to study entry.
  • Any prior radiation therapy within four weeks of enrollment, or prior radiation therapy to the only site of evaluable disease unless disease progression has occurred in that site.
  • Patients on concurrent corticosteroids as treatment for NHL. The use of tapering doses or low doses of corticosteroids for resolving GVHD, or the use of corticosteroids as premedication prior to ONTAK or as a transient treatment for hypersensitivity reactions is permitted as necessary.
  • History of prior malignancy within the preceding 5 years, except for successfully treated cervical carcinoma in situ or basal cell carcinoma.

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): NCT00211276

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United States, California
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211-1850
Pacific Coast Hematology/Oncology
Fountain Valley, California, United States, 92708
University of California, Los Angeles
Los Angeles, California, United States, 90095
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30306
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Iowa
Siouxland Hematology-Oncology
Sioux City, Iowa, United States, 51101-1733
United States, Missouri
Washington University Siteman Cancer Center
St. Louis, Missouri, United States, 63110
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
St. Vincent's Comprehensive Cancer Center
New York, New York, United States, 10011
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
Eisai Inc.
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Principal Investigator: Myron Czuczman, MD Roswell Park Cancer Institute

Layout table for additonal information Identifier: NCT00211276     History of Changes
Other Study ID Numbers: #123
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: March 14, 2012
Last Verified: March 2011
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Denileukin diftitox
Antineoplastic Agents