Overview

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Withdrawn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)