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

This study has been withdrawn prior to enrollment.
(Funding will not be provided for the drug)
Sponsor:
Information provided by:
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00414089
First received: December 19, 2006
Last updated: February 8, 2010
Last verified: July 2007
  Purpose

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 Intervention Phase
Lymphoma
Drug: 90Y-ibritumomab tiuxetan (Zevalin)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • Response

Secondary Outcome Measures:
  • Progression free survival

Estimated Enrollment: 75
  Eligibility

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

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414089

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1X2
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Andrew Belch, MD AHS Cancer Control Alberta
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00414089     History of Changes
Other Study ID Numbers: HE-10-0100
Study First Received: December 19, 2006
Last Updated: February 8, 2010
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014