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Ibritumomab Tiuxetan (Zevalin)+ Rituximab Maintenance

NCT ID: NCT00582166

Last Updated: 2019-12-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-25

Study Completion Date

2013-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Non-Hodgkin's Lymphoma

Keywords

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Zevalin, High Tumor Burden Indolent Non-Hodgkin's Lymphoma, Ibritumomab Tiuxetan

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ibritumomab Tiuxetan (Zevalin) with Rituximab maintenance

Group Type EXPERIMENTAL

Ibritumomab Tiuxetan (Zevalin) + Rituximab

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Zevalin Ibritumomab Tiuxetan Rituximab

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brad S Kahl, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University Of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2011-00579

Identifier Type: REGISTRY

Identifier Source: secondary_id

A534260

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\MEDICINE\HEM-ONC

Identifier Type: OTHER

Identifier Source: secondary_id

HO04405

Identifier Type: -

Identifier Source: org_study_id