Monoclonal Antibody Plus Interleukin-2 in Treating Patients With Leukemia or 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: NCT00002681
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 10, 2011
National Cancer Institute (NCI)
Beth Israel Deaconess Medical Center
Information provided by:
Roger Williams Medical Center

November 1, 1999
January 27, 2003
June 10, 2011
July 1995
September 2003   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00002681 on Archive Site
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Monoclonal Antibody Plus Interleukin-2 in Treating Patients With Leukemia or Lymphoma
Humanized Anti-Tac Antibody Therapy In Hodgkin's Disease, A Phase Ib/II Trial

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Interleukin-2 may stimulate a person's white blood cells to kill leukemia or lymphoma cells. Combining these two therapies may be an effective treatment for leukemia and lymphoma.

PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy plus interleukin-2 in treating patients who have leukemia or lymphoma.


  • Assess the safety and tolerability of a multidose regimen of humanized anti-Tac monoclonal antibody (HAT) and interleukin-2 (IL-2) in patients with leukemia and lymphoma.
  • Describe the pharmacokinetics/pharmacodynamics of HAT and IL-2 in a multidose schedule, including serum half-life of free HAT, area under the curve, and volume of distribution.
  • Evaluate the immunogenicity of HAT.
  • Identify immunologic parameters that correlate with efficacy.
  • Evaluate the preliminary efficacy of HAT in these patients.
  • Monitor patients receiving indium-111-labeled HAT for circulating infused antibody for pharmacokinetics, tumor imaging, and bioactivity (binding ability).

OUTLINE: Patients are stratified according to disease (Hodgkin's lymphoma vs acute myelogenous leukemia vs chronic myelogenous leukemia).

Patients receive humanized anti-TAC monoclonal antibody (HAT) IV over 30 minutes on day 1, then IV over 30 minutes every 7 days and interleukin-2 subcutaneously daily. Treatment continues for up to 1 year in the absence of disease progression, unacceptable toxicity, or development of neutralizing antibodies.

Patients are followed weekly for 2 months.

PROJECTED ACCRUAL: A total of 25 patients with Hodgkin's lymphoma and 14 each with AML and CML will be accrued for this study.

Phase 1
Phase 2
Primary Purpose: Treatment
  • Leukemia
  • Lymphoma
  • Biological: aldesleukin
  • Biological: daclizumab
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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December 2003
September 2003   (Final data collection date for primary outcome measure)


  • Histologically confirmed diagnosis of one of the following malignancies:

    • Hodgkin's lymphoma
    • Acute myelogenous leukemia
    • Chronic myelogenous leukemia
  • Failed standard therapy or in chronic phase if on standard therapy
  • At least 30% of malignant cells reactive with anti-Tac as determined by immunofluorescence studies

    • All Hodgkin's lymphoma patients eligible due to 100% Tac-positivity of Reed-Sternberg cells
  • Measurable disease
  • No symptomatic CNS disease



  • 18 and over

Performance status:

  • 0-2

Life expectancy:

  • Greater than 2 months


  • Not specified


  • Bilirubin no greater than 3 times normal
  • No significant hepatic disease


  • Creatinine no greater than 3 times normal
  • No significant renal disease


  • No significant cardiovascular disease


  • No significant pulmonary disease


  • No significant endocrine, rheumatologic, or allergic disease
  • No HIV-I antibody
  • No active disease due to any of the following:
  • Cytomegalovirus Herpes simplex virus I/II
  • Hepatitis B or C Tuberculosis
  • Negative pregnancy test required of fertile women


Biologic therapy:

  • No prior murine anti-Tac monoclonal antibody


  • At least 4 weeks since chemotherapy

Endocrine therapy:

  • Not specified


  • At least 4 weeks since radiotherapy


  • Not specified


  • Concurrent treatment allowed for complications of primary disease
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Richard Junghans, Roger Williams Medical Center
Roger Williams Medical Center
  • National Cancer Institute (NCI)
  • Beth Israel Deaconess Medical Center
Study Chair: Richard P. Junghans, MD, PhD Beth Israel Deaconess Medical Center
Roger Williams Medical Center
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP