Tositumomab and Iodine I 131 Tositumomab in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma in First Remission
|ClinicalTrials.gov Identifier: NCT00476047|
Recruitment Status : Completed
First Posted : May 21, 2007
Results First Posted : October 12, 2017
Last Update Posted : October 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lymphoid Leukemia in Remission Stage I Chronic Lymphocytic Leukemia Stage II Chronic Lymphocytic Leukemia Stage III Chronic Lymphocytic Leukemia Stage III Small Lymphocytic Lymphoma Stage IV Chronic Lymphocytic Leukemia Stage IV Small Lymphocytic Lymphoma||Combination Product: Tositumomab and Iodine I 131 Tositumomab||Phase 2|
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.
I. To evaluate the toxicities of 131I-tositumomab in 1st remission patients with previously treated CLL/SLL.
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 (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of 131I-Tositumomab (Bexxar®) Consolidation in Patients With B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma in First Remission|
|Study Start Date :||February 2007|
|Primary Completion Date :||February 2015|
|Study Completion Date :||February 2015|
Experimental: Treatment (monoclonal antibody therapy)
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.
Combination Product: Tositumomab and Iodine I 131 Tositumomab
- Probability of Progression-free Survival (PFS) [ Time Frame: 36 months ]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.
- Improved Response Rate After Treatment With 131I-tositumomab for Patients Who Had Evidence of CLL at the End of Initial Chemotherapy [ Time Frame: 3 months after 131I-tositumomab consolidation ]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.
- 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 [ Time Frame: 48 months (median) ]Adverse events following treatment of 131I-tositumomab
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00476047
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Mazyar Shadman||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|