NCT00414089

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2006

Completed
Last Updated

February 15, 2016

Status Verified

July 1, 2007

First QC Date

December 19, 2006

Last Update Submit

February 12, 2016

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Response

Secondary Outcomes (1)

  • Progression free survival

Interventions

90Y-ibritumomab tiuxetan (Zevalin)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1X2, Canada

Location

MeSH Terms

Conditions

Lymphoma

Interventions

ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Andrew Belch, MD

    AHS Cancer Control Alberta

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 19, 2006

First Posted

December 21, 2006

Last Updated

February 15, 2016

Record last verified: 2007-07

Locations

CA(1)