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Denileukin Diftitox in Treating Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia

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: NCT00082940
Recruitment Status : Completed
First Posted : May 19, 2004
Last Update Posted : January 19, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:

RATIONALE: Biological therapies, such as denileukin diftitox, may interfere with the growth of cancer cells and slow the growth of chronic lymphocytic leukemia.

PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating patients with fludarabine-refractory B-cell chronic lymphocytic leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Biological: denileukin diftitox Phase 2

Detailed Description:



  • Determine the complete and partial response rate in patients with fludarabine-refractory B-cell chronic lymphocytic leukemia treated with denileukin diftitox.


  • Determine the toxicity profile of this drug in these patients.
  • Determine the response rate in patients (regardless of CD25 receptor density) treated with this drug.
  • Determine the progression-free survival and overall survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive denileukin diftitox IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Patients achieving a complete response after 8 courses proceed to follow-up. Patients achieving a partial response or stable disease after 8 courses may continue treatment at the discretion of the investigator.

Patients are followed every 3 months for 1 year and then annually until relapse.

PROJECTED ACCRUAL: A total of 12-44 patients will be accrued for this study within 1 year.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of ONTAK® (Denileukin Diftitox, DABIL-2) in Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia
Study Start Date : August 2002
Actual Primary Completion Date : January 2005
Actual Study Completion Date : June 2005

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 to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of B-cell chronic lymphocytic leukemia (CLL) meeting the following criteria at any time during the course of disease (e.g., at initial diagnosis or relapse):

    • Absolute lymphocytosis > 5,000/mm^3
    • Lymphocytes must appear mature with < 55% prolymphocytes
    • More than 30% of all nucleated cells are lymphoid on bone marrow aspirate smear
    • Lymphoid infiltrates compatible with bone marrow involvement by CLL on core bone marrow biopsy
    • Predominant B-cell monoclonal population of cells share the B-cell marker (CD19) with the CD5 antigen in the absence of other pan-T-cell markers by lymphocyte immunophenotyping
  • High-risk disease OR intermediate-risk disease

    • Patients in the intermediate-risk group must have evidence of active disease as demonstrated by at least 1 of the following criteria:

      • Massive or progressive splenomegaly and/or adenopathy
      • Weight loss > 10% within the past 6 months
      • Common toxicity grade 2-4 fatigue
      • Fevers > 100.5°F OR night sweats for more than 2 weeks without evidence of infection
      • Progressive lymphocytosis with an increase of > 50% over a 2-month period or an anticipated doubling time of < 6 months
  • Failed at least 1 prior fludarabine regimen, as defined by 1 of the following criteria:

    • Refractory or intolerant to fludarabine
    • Relapsed within 6 months after completion of fludarabine
  • No CNS leukemia
  • No mantle cell lymphoma in leukemic phase



  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • More than 2 months


  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 50,000/mm^3
  • Hemoglobin ≥ 8 g/dL (transfusion allowed)


  • Albumin ≥ 3 g/dL
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • No hepatitis B or C infection


  • Creatinine ≤ 1.5 mg/dL OR
  • Creatinine clearance ≥ 40 mL/min


  • LVEF ≥ 40%


  • No uncontrolled infection
  • No other concurrent serious illness
  • No HIV infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use two effective methods of contraception (one must be non-hormonal) during and for at least 1 month after study participation


Biologic therapy

  • Prior denileukin diftitox allowed


  • See Disease Characteristics

Endocrine therapy

  • No concurrent corticosteroids as anti-emetics


  • No concurrent radiotherapy


  • Not specified


  • At least 28 days since prior anticancer therapy and recovered
  • No other concurrent antineoplastic drugs

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): NCT00082940

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United States, California
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, United States, 92868-3849
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611
United States, Indiana
Medical Center Vincennes
Vincennes, Indiana, United States, 47591
United States, Louisiana
Cancer Care Specialists
Houma, Louisiana, United States, 70360
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, United States, 71130-3932
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, North Carolina
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States, 27534
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
United States, South Carolina
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Chattanooga Oncology and Hematology Associates
Chattanooga, Tennessee, United States, 37404
United States, Texas
Southwest Regional Cancer Center - Central
Austin, Texas, United States, 78705
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
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Study Chair: Arthur E. Frankel, MD Wake Forest University Health Sciences
Publications of Results:
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Responsible Party: Wake Forest University Health Sciences Identifier: NCT00082940    
Other Study ID Numbers: CCCWFU-27102
CDR0000361734 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: May 19, 2004    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: June 2013
Keywords provided by Wake Forest University Health Sciences:
B-cell chronic lymphocytic leukemia
refractory chronic lymphocytic leukemia
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Denileukin diftitox
Antineoplastic Agents