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Iodine

Cadexomer iodine

Tositumomab I-131

Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes.

Tositumomab and Iodine I 131 Tositumomab

Mazyar Shadman

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.

Tositumomab and Iodine I 131 Tositumomab in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma in First Remission

A Study of 131I-Tositumomab (Bexxar®) Consolidation in Patients With B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma in First Remission

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.

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.

Adverse events following treatment of 131I-tositumomab

National Cancer Institute (NCI)

Fred Hutchinson Cancer Center

Principal Investigator

Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes.

Tositumomab and Iodine I 131 Tositumomab: Give IV

Laboratory Biomarker Analysis: Correlative studies

Treatment (Monoclonal Antibody Therapy)

Age, Continuous

Sex: Female, Male

CLL or SLL

Prior chemotherapy

CRITERIA FOR RESPONSE Criteria for response are specified by the NCI working group guidelines; in addition, patients will be required to meet computed tomography (CT) scan criteria as defined in the protocol.

Complete response (CR) Partial response (PR) Progressive Disease (PD) Stable Disease (SD)

Disease status before 131 I-tositumomab

MRD was assessed on bone marrow samples using 8 color flow cytometry to detect CLL/SLL cells. Any level of residual disease by flow cytometry or cytogenetics was considered MRD positive. Negativity of both tests was required to classify a patient as MRD negative.

Minimal Residual Disease (MRD) status before 131 I-tositumomab

Mazyar Shadman, MD

Probability of Progression-free Survival (PFS)

Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes.

Tositumomab and Iodine I 131 Tositumomab: Give IV

Participants who had a partial response (PR) after initial chemotherapy. Response assessed using NCI working group guidelines + CT criteria as described in the protocol.

Improved Response Rate After Treatment With 131I-tositumomab for Patients Who Had Evidence of CLL at the End of Initial Chemotherapy

Patients who received study treatment and who had achieved a complete remission (CR) after any prior therapy.

Patient Who Achieved CR After Any Prior Therapy

Minimal Residual Disease (MRD) by Flow Cytometry or Polymerase Chain Reaction (PCR) in Patients Who Had a Complete Remission (CR) After Any Prior Therapy

Spots Global Cancer Trial Database for lymphoid leukemia in remission