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

This study has been completed.

Sponsors and Collaborators: Wake Forest University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00082940
  Purpose

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 Intervention Phase
Leukemia
Drug: denileukin diftitox
Phase II

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic   

Drug Information available for:   Fludarabine    Fludarabine monophosphate    Denileukin diftitox   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   A Phase II Study of ONTAK® (Denileukin Diftitox, DABIL-2) in Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   August 2002

Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • 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.

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

Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • More than 2 months

Hematopoietic

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

Hepatic

  • 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

Renal

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

Cardiovascular

  • LVEF ≥ 40%

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior denileukin diftitox allowed

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • No concurrent corticosteroids as anti-emetics

Radiotherapy

  • No concurrent radiotherapy

Surgery

  • Not specified

Other

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082940

Locations
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
Comprehensive Cancer Center at Wake Forest University    
      Winston-Salem, North Carolina, United States, 27157-1082
Southeastern Medical Oncology Center    
      Goldsboro, North Carolina, United States, 27534
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
National Cancer Institute (NCI)

Investigators
Study Chair:     Arthur E. Frankel, MD     Wake Forest University    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000361734, CCCWFU-27102, CCCWFU-BG02-331, LIGAND-CCCWFU-27102
First Received:   May 14, 2004
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00082940
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
B-cell chronic lymphocytic leukemia  
refractory chronic lymphocytic leukemia  

Study placed in the following topic categories:
Chronic lymphocytic leukemia
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Interleukin-2
Leukemia, Lymphocytic, Chronic, B-Cell
Denileukin diftitox
Fludarabine
Fludarabine monophosphate
Lymphoproliferative Disorders
Leukemia, B-Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Sensory System Agents
Analgesics, Non-Narcotic
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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