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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AHS Cancer Control Alberta
• Treatments: Antibodies, Monoclonal

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)