Ibritumomab Tiuxetan (Zevalin)+ Rituximab Maintenance

Phase 2TerminatedNCT00582166

University of Wisconsin, Madison18 enrolled

Overview

Subjects will receive the Ibritumomab Tiuxetan (Zevalin) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Hodgkin's Lymphoma

Interventions

Ibritumomab Tiuxetan (Zevalin) + RituximabDRUG

Subjects will receive the Ibritumomab Tiuxetan (Zevalin) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Locations (1)

University Of Wisconsin

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Median Progression Free Survival (PFS)

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).

Time frame: up to 5 years, 9.5 months, from first day on treatment to last follow up

Secondary Outcomes

24-month Progression Free Survival (PFS)

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.

Time frame: Up to 24 months

Response Rates

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).

Time frame: Up to 5 years and 9.5 months

Data from ClinicalTrials.gov

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