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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
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison

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

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: Ibritumomab Tiuxetan (Zevalin) + Rituximab Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
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
Other Names:
  • Zevalin
  • Ibritumomab Tiuxetan
  • Rituximab


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. Overall Survival (OS) [ Time Frame: At 12 months ]
    To estimate overall survival, 95% confidence intervals will be used.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Wisconsin
University Of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Genentech, Inc.
Investigators
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Principal Investigator: Brad S Kahl, MD University of Wisconsin, Madison
More Information
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00582166    
Other Study ID Numbers: HO04405
NCI-2011-00579 ( Registry Identifier: NCI Trial ID )
A534260 ( Other Identifier: UW Madison )
SMPH\MEDICINE\HEM-ONC ( Other Identifier: UW Madison )
First Posted: December 28, 2007    Key Record Dates
Results First Posted: July 13, 2018
Last Update Posted: December 13, 2019
Last Verified: July 2018
Keywords provided by University of Wisconsin, Madison:
Zevalin, High Tumor Burden Indolent Non-Hodgkin's Lymphoma, Ibritumomab Tiuxetan
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Rituximab
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents