Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00476047
Status:
COMPLETED
Last Update Posted:
2017-10-12
First Post:
2007-05-17
Brief Title:
Tositumomab and Iodine I 131 Tositumomab in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma in First Remission
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Study of 131I-Tositumomab Bexxar Consolidation in Patients With B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma in First Remission
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 CLLSLL 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 CLLSLL
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
I To estimate the progression-free survival at 2 years following administration of 131I-tositumomab tositumomab and iodine I 131 tositumomab in patients with CLLSLL 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 CLLSLL
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2011-01311 | REGISTRY | None | None |
| PSOC 2301 | OTHER | None | None |
| P30CA015704 | NIH | Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP30CA015704 |