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Clinical Trial · NCT00414089
Efficacy and Safety of Treatment With a Single Dose of 90Y-ibritumomab Tiuxetan in Patients With Low Tumor Burden Untreated or Indolent NHL
Overview
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.
Sponsor
AHS Cancer Control Alberta
Phase
Phase 2
Contacts
Andrew Belch, MD (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT00414089Drug / Compound
ibritumomab tiuxetan
Isotope(s):
YTTRIUM-90
Radioisotope: Y-90
Theranostic Role: Therapeutic Agent, SPECT Imaging & PET Imaging
T1/2 (Half-Life): 2.7 Days
Decay Mode: BETA
Energy: max 2.2 MeV
Range: In Tissue: Avg 2.5 mm, Max 11 mm; In Air: 35 feet
Decay Daughters: Zr90 (Stable)
Status: FDA Approvals: SIR-SPHERES® (2000), THERASPHERES® (2021)
Target(s):
- cd20
Ligand Class: Antibodies
Chelator: Tiuxetan
Eligibility
Inclusion
- small lymphocytic
- absolute lymphocyte count ≤ x 109/L
- absolute neutrophil count ≥ 1.5 x 109/L
- involvement by less than 25% of bone marrow on assessment of trephine biopsy
- No prior therapy
- no evidence of transformation
- mucosa associated lymphoid tissue (MALT)
- histologically confirmed indolent lymphoma including:
- Stage III or IV disease
- platelets ≥ 150 x 109/L
- at least one bidimensionally measurable lesion at least 2cm by CT scanning
- marginal zone (nodal)
- marginal zone (splenic)
- follicular grade 1 or 2
- hemoglobin ≥ 100g/L
Exclusion
- known hypersensitivity to murine antibodies or proteins
- prior radiation therapy
- patients known to be HIV positive
- immunotherapy during the preceding 6 months (including monoclonal antibodies, interleukins, interferon)
- patients with known seropositivity for Hepatitis C virus, Hepatitis B virus or other active infection uncontrolled by treatment
- prior myeloablative therapy (bone marrow or peripheral blood stem cell transplant)
- any other anticancer treatment for NHL
- presence of central nervous system lymphoma
- patients with abnormal renal function: serum creatinine \> 2.5X ULN
- patients with abnormal liver function: total bilirubin \> 1.5X ULN or ALT \> 2.5X ULN
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