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Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Waldenstrom's Macroglobulinemia

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: NCT00060294
Recruitment Status : Terminated (no accrual)
First Posted : May 7, 2003
Last Update Posted : January 8, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Brief Summary:

RATIONALE: Monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan and rituximab can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of yttrium Y 90 ibritumomab tiuxetan in treating patients who have Waldenstrom's macroglobulinemia.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: rituximab Radiation: yttrium Y 90 ibritumomab tiuxetan Phase 1

Detailed Description:


  • Determine the maximum tolerated dose of yttrium Y 90 ibritumomab tiuxetan in patients with Waldenstrom's macroglobulinemia.
  • Determine, preliminarily, the response of patients treated with this drug.

OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8).

Patients receive rituximab IV and indium In 111 ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 1. Patients then undergo gamma camera scans within 2-24 hours. Approximately 7-14 days after IDEC-In2B8, patients receive rituximab IV and IDEC-Y2B8 IV over 10 minutes. Treatment with IDEC-Y2B8 may repeat every 12 weeks in the absence of unacceptable toxicity or the achievement of a maximum cumulative dose.

Cohorts of 3-6 patients receive escalating doses of IDEC-Y2B8 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 toxicity.

Patients are followed every 3 months for 4 years.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I Study of Zevalin (90Y-Ibritumomab Tiuxetan) in Waldenstrom's Macroglobulinemia (Lymphoplasmacytic Lymphoma)
Study Start Date : April 2003
Actual Primary Completion Date : June 2004

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


  • Diagnosis of Waldenstrom's macroglobulinemia confirmed by IgM gammopathy and bone marrow biopsy

    • Presence of lymphoplasmacytic cells
    • CD20+ plasma cell dyscrasia on the majority of malignant cells
    • Bone marrow involvement of 20-50% by core needle biopsy of at least 1.5 cm in length
  • Clinical indication for initiation of treatment, including 1 or more of the following characteristics:

    • Symptoms associated with the disease (e.g., fatigue, asthenia, or painful adenopathy)
    • Anemia
    • IgM greater than 3 g/L
    • Progression as indicated by a rate of IgM rise of more than 0.5 g over 6 months
  • No myelodysplastic syndromes or profound hypocellularity of the bone marrow



  • Over 18

Performance status

  • WHO 0-2

Life expectancy

  • More than 3 months


  • Absolute neutrophil count greater than 1,500/mm^3
  • Total B-lymphocyte count less than 5,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • No hyperviscosity syndrome


  • Bilirubin no greater than 1.5 mg/dL


  • Not specified


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 year after study completion
  • No uncontrolled CNS disease
  • No serious nonmalignant disease that would preclude study participation
  • No other concurrent active malignancy except controlled skin cancer or prostate cancer


Biologic therapy

  • More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
  • More than 4 months since prior rituximab
  • No prior radioimmunotherapy


  • No prior high-dose chemotherapy (unless patient has had prior back-up stem cell collections)
  • More than 6 weeks since prior chemotherapy

Endocrine therapy

  • More than 4 weeks since prior corticosteroids


  • No prior radiotherapy


  • 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): NCT00060294

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United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Christos E. Emmanouilides, MD Jonsson Comprehensive Cancer Center
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Responsible Party: Jonsson Comprehensive Cancer Center Identifier: NCT00060294    
Other Study ID Numbers: CDR0000301591
First Posted: May 7, 2003    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: January 2013
Keywords provided by Jonsson Comprehensive Cancer Center:
Waldenström macroglobulinemia
Additional relevant MeSH terms:
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Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents