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Trial record 5 of 45 for:    "T-Cell Adult Acute Lymphocytic Leukemia" | "Hormones"

Monoclonal Antibody Therapy in Treating Patients With 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: NCT00019227
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 20, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody plus pentetic acid calcium in patients with leukemia.

Condition or disease Intervention/treatment Phase
Lymphoma Radiation Toxicity Drug: pentetic acid calcium Radiation: yttrium Y 90 daclizumab Phase 1 Phase 2

Detailed Description:


  • Determine the maximum tolerated dose of yttrium Y 90 daclizumab (90Y daclizumab) when combined with pentetic acid calcium in adults with Tac-expressing T-cell leukemia.
  • Determine the therapeutic efficacy and toxicity of this regimen in these patients.
  • Monitor patients treated on this regimen for circulating infused antibody (free and labeled) and for the serum concentration of soluble interleukin-2 receptor.
  • Evaluate, in a preliminary manner, the immunogenicity of daclizumab.
  • Determine the effect of 90Y daclizumab on various components of the circulating cellular immune system.
  • Determine whether there is additional urinary excretion of yttrium Y 90 when compared to that observed previously in patients treated without pentetic acid calcium.

OUTLINE: This is a dose escalation study of yttrium Y 90 daclizumab (90Y daclizumab).

Patients receive 90Y daclizumab IV over 2 hours on day 1 and a fixed dose of pentetic acid calcium IV over 5 hours for 3 days. Treatment repeats every 6 weeks for a maximum of 9 courses in the absence of disease progression or circulating antibodies to humanized anti-Tac.

Cohorts of 3-6 patients receive escalating doses of 90Y daclizumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Additional patients are treated at the MTD.

Patients are followed at 4-6 weeks.

PROJECTED ACCRUAL: Up to 15 patients will be accrued for the phase I portion of the study. A total of 30 patients will be accrued for the phase II portion of the study.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Study Start Date : October 1996
Actual Study Completion Date : July 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed adult T-cell leukemia or lymphoma (ATL) of any stage
  • Tac expression of malignant cells confirmed by one of the following:

    • At least 10% of peripheral blood, lymph node, or dermal malignant cells reactive with anti-Tac by immunofluorescent staining
    • Soluble interleukin-2 receptor levels greater than 1,000 U/mL (normal geometric mean = 235; 95% confidence intervals = 112-502 U/mL)
  • Measurable disease required

    • More than 10% (i.e., strongly Tac-expressing) abnormal cells in peripheral blood considered measurable disease
  • All stages of Tac-expressing adult T-cell leukemia are eligible

    • Smoldering ATL patients are eligible only if the symptoms and sites of involvement by ATL are such that there is a medical indication to treat

      • Smoldering ATL, defined as:

        • Lymphocyte count less than 4,000/mm^3
        • Less than 5% abnormal lymphocytes on morphologic exam of peripheral blood
        • No hypercalcemia
        • Lactate dehydrogenase no greater than 1.5 times normal
        • No lymphadenopathy
        • No involvement of extranodal organs except skin or lung
        • No malignant pleural effusion or ascites
  • No symptomatic CNS disease due to ATL

    • Concurrent diagnosis of tropical spastic paraparesis allowed
  • No detectable levels (i.e., greater than 250 ng/mL) of antibody to study drug as assessed by ELISA



  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • Greater than 2 months


  • Absolute granulocyte count at least 1,000/mm^3
  • Platelet count at least 75,000/mm^3


  • Bilirubin less than 2.0 mg/dL (unless directly due to ATL)
  • AST/ALT less than 2.5 times normal


  • Creatinine less than 1.5 mg/dL OR
  • Creatinine clearance greater than 35 mL/min


  • No clinical cardiac failure


  • No symptomatic pulmonary dysfunction unless due to underlying malignancy


  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test


Biologic therapy

  • Not specified


  • At least 4 weeks since prior cytotoxic chemotherapy

Endocrine therapy

  • Concurrent corticosteroids allowed


  • Not specified


  • Not specified


  • Not specified

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): NCT00019227

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United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
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Study Chair: Thomas A. Waldmann, MD NCI - Metabolism Branch;MET

Layout table for additonal information Identifier: NCT00019227     History of Changes
Obsolete Identifiers: NCT00001514
Other Study ID Numbers: CDR0000065240
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: March 2003
Keywords provided by National Cancer Institute (NCI):
stage I adult T-cell leukemia/lymphoma
stage II adult T-cell leukemia/lymphoma
stage III adult T-cell leukemia/lymphoma
stage IV adult T-cell leukemia/lymphoma
recurrent adult T-cell leukemia/lymphoma
radiation toxicity
Additional relevant MeSH terms:
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Leukemia-Lymphoma, Adult T-Cell
Calcium-Regulating Hormones and Agents
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, T-Cell
Leukemia, Lymphoid
Calcium, Dietary
Pentetic Acid
Physiological Effects of Drugs
Bone Density Conservation Agents
Immunosuppressive Agents
Immunologic Factors
Protective Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Iron Chelating Agents