This phase II trial studies how well tositumomab and iodine I 131 tositumomab works in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that have had their first decrease in or disappearance of signs and symptoms of cancer (first remission). Monoclonal antibodies, such as tositumomab and iodine I 131 tositumomab, may block cancer growth in different ways by targeting certain cells.
PRIMARY OBJECTIVES: I. To estimate the progression-free survival at 2 years following administration of 131I-tositumomab (tositumomab and iodine I 131 tositumomab) in patients with CLL/SLL who achieve a complete remission (CR) or partial remission (PR) with prior therapy. II. To improve the response rate by administering 131I-tositumomab to patients who have achieved a PR not a CR after any prior therapy. III. To eliminate residual disease (documented by flow cytometry or polymerase chain reaction \[PCR\]) using 131I-tositumomab in patients who have achieved a CR after any prior therapy. SECONDARY OBJECTIVES: I. To evaluate the toxicities of 131I-tositumomab in 1st remission patients with previously treated CLL/SLL. OUTLINE: Patients receive tositumomab and iodine I 131 tositumomab intravenously (IV) over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes. After completion of study treatment, patients are followed up weekly for 3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Give IV
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Probability of Progression-free Survival (PFS)
Progression free survival (PFS) is defined as the interval between the first treatment day to the first sign of disease progression. This outcome measures the percentage of participants with PFS at 36 months.
Time frame: 36 months
Improved Response Rate After Treatment With 131I-tositumomab for Patients Who Had Evidence of CLL at the End of Initial Chemotherapy
Response rates determined using National Cancer Institute (NCI) working group guidelines plus computed tomography (CT) scan criteria. Participants were assessed for response after initial chemotherapy and again 3 months after 131I-tositumomab treatment.Only patients who had less than a complete response (CR) after initial chemotherapy were assessed for improved response after 131I-tositumomab.
Time frame: 3 months after 131I-tositumomab consolidation
Minimal Residual Disease (MRD) by Flow Cytometry or Polymerase Chain Reaction (PCR) in Patients Who Had a Complete Remission (CR) After Any Prior Therapy
Time frame: 3 months after 131I-tositumomab consolidation
Evaluate Toxicities of 131I-tositumomab
Adverse events following treatment of 131I-tositumomab
Time frame: 48 months (median)
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