SWOG clinical trial number
C50201
A Phase II Study to Evaluate the Safety and Efficacy of Zevalin® (IND # BB IND 11023)Therapeutic Regimen in Patients With Transformed CD20+ B-Cell Non-Hodgkin's Lymphoma
Closed
Phase
Abbreviated Title
NON-HODGKIN'S: Zevalin Treatment for Transformed CD20+ B-Cell NHL
Activated
12/15/2005
Closed
04/13/2007
Participants
Research committees
Lymphoma
Treatment
Allopurinol
Rituximab
Yttrium-90 ibritumomab tiuxetan
Eligibility Criteria Expand/Collapse
Histologically confirmed, transformed CD20+ B-cell NHL requiring treatment as determined by an increase in overall tumor size, the presence of B symptoms and/or the presence of masses which are causing ongoing clinical symptomatology; must have < 25% bone marrow involvement with lymphoma
within six weeks prior to registration; patients with de novo transformed NHL are not eligible; no CNS disease; measurable disease must be present; patients with expected impairment in bone marrow reserve are not eligible; no anti-cancer therapy for three weeks (six weeks if rituximab, nitrosourea, or Mitomycin C) prior to registration, and fully recovered from all toxicities associated with prior surgery, radiation, chemotherapy or immuno therapy; no prior myeloablative therapies with BMT or PBSC rescue; no prior radioimmunotherapy including Zevalin®; no prior external beam radiation therapy to > 25% of active bone marrow (involved field or regional); no prior G-CSF or GM-CSF within two weeks prior to registration; no major surgery other than diagnostic surgery within 4 weeks prior to registration; no concurrent systemic corticosteroid therapy; HAMA reactivity testing will be performed in those patients with prior exposure to murine antibodies; no HIV infection; patients with peritoneal or pleural invasion and/or ascites are eligible if effusion or ascites can be tapped dry; PS=0-2; Age >= 18 years; no “currently active” second malignancy; non-pregnant and non-lactating;
Initial Required Laboratory Values
ANC >= 1500/mcL
Lymphocyte count <= 5000/mcL*
Platelet count >= 150,000/mcL
Total bilirubin <= 2.0 mg/dL
Serum creatinine <= 2.0 mg/dL
*for patients with SLL.
within six weeks prior to registration; patients with de novo transformed NHL are not eligible; no CNS disease; measurable disease must be present; patients with expected impairment in bone marrow reserve are not eligible; no anti-cancer therapy for three weeks (six weeks if rituximab, nitrosourea, or Mitomycin C) prior to registration, and fully recovered from all toxicities associated with prior surgery, radiation, chemotherapy or immuno therapy; no prior myeloablative therapies with BMT or PBSC rescue; no prior radioimmunotherapy including Zevalin®; no prior external beam radiation therapy to > 25% of active bone marrow (involved field or regional); no prior G-CSF or GM-CSF within two weeks prior to registration; no major surgery other than diagnostic surgery within 4 weeks prior to registration; no concurrent systemic corticosteroid therapy; HAMA reactivity testing will be performed in those patients with prior exposure to murine antibodies; no HIV infection; patients with peritoneal or pleural invasion and/or ascites are eligible if effusion or ascites can be tapped dry; PS=0-2; Age >= 18 years; no “currently active” second malignancy; non-pregnant and non-lactating;
Initial Required Laboratory Values
ANC >= 1500/mcL
Lymphocyte count <= 5000/mcL*
Platelet count >= 150,000/mcL
Total bilirubin <= 2.0 mg/dL
Serum creatinine <= 2.0 mg/dL
*for patients with SLL.
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Activated
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