Status:
WITHDRAWN
Efficacy and Safety of Treatment With a Single Dose of 90Y-ibritumomab Tiuxetan in Patients With Low Tumor Burden Untreated or Indolent NHL
Lead Sponsor:
AHS Cancer Control Alberta
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00414089
Last Update
February 15 2016
Active Locations (1)
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1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1X2