Ibritumomab Tiuxetan (Zevalin)+ Rituximab Maintenance
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- Registration Number
- NCT00582166
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
Subjects will receive the Ibritumomab Tiuxetan (Zevalin) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
- Detailed Description
The objective of this study is to estimate the median progression-free survival for patients receiving this regimen, along with the rate of complete response at 6 months, toxicities associated with this regimen, and laboratory correlates. Subjects will receive the Ibritumomab Tiuxetan (Zevalin) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 18
- Patients with biopsy-proven non-hodgkins lymphoma of follicular grade 1, 2, or 3
- Meeting FLIPI criteria for intermediate or high risk.
- No prior chemotherapy, radiotherapy or immunotherapy for lymphoma;
- Patients may not have known HIV infection, and must not be Hepatitis B Surface Antigen positive.
- May not be pregnant or breastfeeding, have documented CNS (Central Nervous System) disease, G-CSF (Granulocyte Colony Stimulating Facto) or GM-CSF (Granulocyte/Macrophage Colony Stimulating Factor) within 2 weeks prior
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ibritumomab Tiuxetan (Zevalin) with Rituximab maintenance Ibritumomab Tiuxetan (Zevalin) + Rituximab -
- Primary Outcome Measures
Name Time Method Median Progression Free Survival (PFS) 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).
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) At 12 months To estimate overall survival, 95% confidence intervals will be used.
24-month Progression Free Survival (PFS) 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 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 Up to 5 years and 9.5 months To record the toxicities associated with this regimen.
Trial Locations
- Locations (1)
University Of Wisconsin
🇺🇸Madison, Wisconsin, United States