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

NCT ID: NCT00414089

Last Updated: 2016-02-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

90Y-ibritumomab tiuxetan (Zevalin)

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AHS Cancer Control Alberta

OTHER

Sponsor Role: lead

Principal Investigators

Andrew Belch, MD

Role: PRINCIPAL_INVESTIGATOR

AHS Cancer Control Alberta

Locations

Cross Cancer Institute

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

HE-10-0100

Identifier Type: -

Identifier Source: org_study_id