Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

Efficacy and Safety of Treatment With a Single Dose of 90Y-ibritumomab Tiuxetan in Patients With Low Tumor Burden Untreated or Indolent NHL

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: NCT00414089
Recruitment Status : Withdrawn (Funding will not be provided for the drug)
First Posted : December 21, 2006
Last Update Posted : February 15, 2016
Information provided by:
AHS Cancer Control Alberta

Brief Summary:
The purpose of this study is to see how well Zevalin works in the treatment of low grade indolent B-cell lymphoma when given to patients who have not had any previous treatment for their lymphoma and who otherwise would be followed on a "watch & wait" policy.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: 90Y-ibritumomab tiuxetan (Zevalin) Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Treatment With a Single Dose of 90Y-ibritumomab Tiuxetan in Patients With Previously Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Primary Outcome Measures :
  1. Response

Secondary Outcome Measures :
  1. Progression free survival

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.

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

Inclusion Criteria:

  • histologically confirmed indolent lymphoma including:

    • follicular grade 1 or 2
    • small lymphocytic
    • marginal zone (nodal)
    • marginal zone (splenic)
    • mucosa associated lymphoid tissue (MALT)
  • no evidence of transformation
  • Stage III or IV disease
  • No prior therapy
  • involvement by less than 25% of bone marrow on assessment of trephine biopsy
  • absolute lymphocyte count ≤ x 109/L
  • platelets ≥ 150 x 109/L
  • hemoglobin ≥ 100g/L
  • absolute neutrophil count ≥ 1.5 x 109/L
  • at least one bidimensionally measurable lesion at least 2cm by CT scanning

Exclusion Criteria:

  • any other anticancer treatment for NHL
  • prior radiation therapy
  • prior myeloablative therapy (bone marrow or peripheral blood stem cell transplant)
  • no other malignancy within the past 10 years except adequately treated non-melanoma skin tumors or carcinoma in situ of the cervix
  • presence of central nervous system lymphoma
  • patients known to be HIV positive
  • patients with known seropositivity for Hepatitis C virus, Hepatitis B virus or other active infection uncontrolled by treatment
  • patients with abnormal liver function: total bilirubin > 1.5X ULN or ALT > 2.5X ULN
  • patients with abnormal renal function: serum creatinine > 2.5X ULN
  • known hypersensitivity to murine antibodies or proteins
  • immunotherapy during the preceding 6 months (including monoclonal antibodies, interleukins, interferon)

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): NCT00414089

Layout table for location information
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1X2
Sponsors and Collaborators
AHS Cancer Control Alberta
Layout table for investigator information
Principal Investigator: Andrew Belch, MD AHS Cancer Control Alberta

Layout table for additonal information Identifier: NCT00414089    
Other Study ID Numbers: HE-10-0100
First Posted: December 21, 2006    Key Record Dates
Last Update Posted: February 15, 2016
Last Verified: July 2007
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs