Ibritumomab Tiuxetan (Zevalin)+ Rituximab Maintenance
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|ClinicalTrials.gov Identifier: NCT00582166|
Recruitment Status : Terminated (See 'Limitations and Caveats' section)
First Posted : December 28, 2007
Results First Posted : July 13, 2018
Last Update Posted : December 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkin's Lymphoma||Drug: Ibritumomab Tiuxetan (Zevalin) + Rituximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ibritumomab Tiuxetan Plus Rituximab as Initial Therapy for Patients With High Tumor Burden, Indolent Histology Non-Hodgkin's Lymphoma|
|Actual Study Start Date :||January 25, 2005|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
|Experimental: Ibritumomab Tiuxetan (Zevalin) with Rituximab maintenance||
Drug: Ibritumomab Tiuxetan (Zevalin) + Rituximab
Subjects will receive the Ibritumomab Tiuxetan (Zevalin) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
- Median Progression Free Survival (PFS) [ Time Frame: up to 5 years, 9.5 months, from first day on treatment to last follow up ]Estimate median progression free survival (PFS), where PFS is defined as the number of days from administration of Ibritumomab tiuxetan In111 (defined as day 1) until the participant develops progressive disease or death from NHL (Non-Hodgkin's Lymphoma).
- 24-month Progression Free Survival (PFS) [ Time Frame: Up to 24 months ]
Estimate the 24 month progression free survival (PFS), where PFS is defined as the number of days from the first Ibritumomab tiuxetan administration (day 0) to the day the patient experiences an event of disease progression (or death). PFS is summarized as the percentage of patients that survived progression free after 24 months.
Progression is defined as any of the following:
- Appearances of any new lesions/sites during or after therapy.
- Increase of >/= 50% in the SPD (sum of perpendicular diameter) from nadir measurement of all involved dominant lymph nodes and liver nodules and spleen nodules or unequivocal progression in any nonmeasurable disease or nondominant site.
- Increase by > 50% in greatest diameter from nadir measurement of any previously involved dominant node > 1.0 cm in its short axis.
- Response Rates [ Time Frame: Up to 5 years and 9.5 months ]To estimate the Complete Response and unconfirmed Complete Response rate (assessing Ibritumomab tiuxetan). Complete response is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms, and all dominant lymph nodes and nodal masses have regressed to normal size, and complete resolution of lymphoma in the bone marrow biopsy. Unconfirmed Complete Response (CRu) defined as the above, but with either a > 1.5cm residual node that has decreased by >75%, and/or individual nodes that were previously confluent that have decreased by >75% in SPD, and/or indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).
- Number of Participants Experiencing Toxicities, Measured by CTCAE v3.0 [ Time Frame: Up to 5 years and 9.5 months ]To record the toxicities associated with this regimen.
- Overall Survival (OS) [ Time Frame: At 12 months ]To estimate overall survival, 95% confidence intervals will be used.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00582166
|United States, Wisconsin|
|University Of Wisconsin|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Brad S Kahl, MD||University of Wisconsin, Madison|