Trial Information

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

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) in first remission. Monoclonal antibodies, such as tositumomab and iodine I 131 tositumomab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer cancer-killing substances to them.

Patient Inclusion Criteria:

18 Years and older
Patients with a diagnosis of cluster of differentiation (CD)20+ CLL/SLL; prior to the first treatment patients with CLL must have been either Rai stage III/IV disease or Rai stage I/II with evidence of disease activity as defined by the National Cancer Institute (NCI) 1996 guidelines, and patients with SLL must have been Stage III or IV per Ann Arbor staging system
Patient has received prior therapy and is in 1st remission with a partial or complete response to treatment
Patients must have no more than 25% of the intratrabecular marrow space involved by leukemia in bone marrow biopsy specimens as assessed microscopically after completion of treatment; bilateral posterior iliac crest core biopsies are required if the percentage of intratrabecular space involved exceeds 10% on a unilateral biopsy; the mean of bilateral biopsies must be no more than 25%
Patient must have consented to participate in the study and signed and dated an appropriate institutional review board (IRB)-approved consent form that conforms to federal and institutional guidelines
Patient must have a Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 (0 = fully active, able to carry on all pre-disease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory and ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = ambulatory and capable of all self-care but unable to carry out any work activities and is up and about more than 50% of waking hours)
Patient must have an anticipated survival of at least 3 months
Granulocytes >= 1,500/uL within 14 days of planned dosimetric infusion
Platelets >= 100,000/uL within 14 days of planned dosimetric infusion
White blood count =< 20,000/mm^3
Serum creatinine < 2 times upper limit of normal
Total bilirubin < 2 times upper limit of normal
Aspartate aminotransferase (AST) < 5 times upper limit of normal
Males and females must agree to use a contraceptive method from enrollment to 6 months after receiving I-131 labeled tositumomab

Patient Exclusion Criteria:

Patients who have received prior radiolabeled antibody
Patients with active hemolysis
Patients must not require sustained transfusion support of blood products
Patients in 2nd remission or beyond
Patients who have undergone treatment with either stem cell or bone marrow transplant
Patients with active obstructive hydronephrosis
Patients with evidence of any significant systemic illness, active Hepatitis B infection or other active infection at the time of study entry
Patients with New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation
Patients with known human immunodeficiency virus (HIV) infection
Patients who are pregnant or nursing
Patients with prior malignancy other than CLL/SLL, except for adequately treated skin cancer (basal cell or squamous cell carcinoma), in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years unless approved by the principal investigator (PI)
Patients with active brain or leptomeningeal involvement by malignancy
Patients who have, in the opinion of the investigator, other medical, social, or psychosocial factors that may negatively impact compliance or their safety by participation in this study

Christine Goetz, BA; CCRC
MultiCare Health System
314 Martin Luther King, Jr. Way, Suite 402
Tacoma, WA 98405
Phone: 253-403-7193
Email: Christine.Goetz@multicare.org

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Research Center Information: MultiCare Health System

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