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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00414089
• Other study ID #: HE-10-0100
• Status: Withdrawn
• Phase: Phase 2
• First received: December 19, 2006
• Last updated: February 12, 2016

Study information

• Verified date: July 2007
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• 90Y-ibritumomab tiuxetan (Zevalin)

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response
Secondary	Progression free survival