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Ibritumomab Tiuxetan (Zevalin)+ Rituximab Maintenance

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ibritumomab Tiuxetan (Zevalin) + Rituximab
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring Zevalin, High Tumor Burden Indolent Non-Hodgkin's Lymphoma, Ibritumomab Tiuxetan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ibritumomab Tiuxetan (Zevalin) with Rituximab maintenance

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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).
Number of Participants Experiencing Toxicities, Measured by CTCAE v3.0
To record the toxicities associated with this regimen.
Overall Survival (OS)
To estimate overall survival, 95% confidence intervals will be used.

Full Information

First Posted
December 19, 2007
Last Updated
December 11, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00582166
Brief Title
Ibritumomab Tiuxetan (Zevalin)+ Rituximab Maintenance
Official Title
Ibritumomab Tiuxetan Plus Rituximab as Initial Therapy for Patients With High Tumor Burden, Indolent Histology Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
See 'Limitations and Caveats' section
Study Start Date
January 25, 2005 (Actual)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
Keywords
Zevalin, High Tumor Burden Indolent Non-Hodgkin's Lymphoma, Ibritumomab Tiuxetan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ibritumomab Tiuxetan (Zevalin) with Rituximab maintenance
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ibritumomab Tiuxetan (Zevalin) + Rituximab
Other Intervention Name(s)
Zevalin, Ibritumomab Tiuxetan, Rituximab
Intervention Description
Subjects will receive the Ibritumomab Tiuxetan (Zevalin) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
Primary Outcome Measure Information:
Title
Median Progression Free Survival (PFS)
Description
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 Outcome Measure Information:
Title
24-month Progression Free Survival (PFS)
Description
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
Title
Response Rates
Description
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
Title
Number of Participants Experiencing Toxicities, Measured by CTCAE v3.0
Description
To record the toxicities associated with this regimen.
Time Frame
Up to 5 years and 9.5 months
Title
Overall Survival (OS)
Description
To estimate overall survival, 95% confidence intervals will be used.
Time Frame
At 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brad S Kahl, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Ibritumomab Tiuxetan (Zevalin)+ Rituximab Maintenance

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