NCT00582166

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2005

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 28, 2007

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

July 13, 2018

Completed
Last Updated

December 13, 2019

Status Verified

July 1, 2018

Enrollment Period

8.1 years

First QC Date

December 19, 2007

Results QC Date

November 16, 2017

Last Update Submit

December 11, 2019

Conditions

Non-Hodgkin's Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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).

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

Secondary Outcomes (4)

  • 24-month Progression Free Survival (PFS)

    Up to 24 months

  • Response Rates

    Up to 5 years and 9.5 months

  • Number of Participants Experiencing Toxicities, Measured by CTCAE v3.0

    Up to 5 years and 9.5 months

  • Overall Survival (OS)

    At 12 months

Study Arms (1)

Ibritumomab Tiuxetan (Zevalin) with Rituximab maintenance

EXPERIMENTAL
Drug: Ibritumomab Tiuxetan (Zevalin) + Rituximab

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

Also known as: Zevalin, Ibritumomab Tiuxetan, Rituximab
Ibritumomab Tiuxetan (Zevalin) with Rituximab maintenance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

ibritumomab tiuxetanRituximab

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Limitations and Caveats

From IRB: Subjects have completed therapy, ended therapy to progressive disease, or withdrawn. Low enrollment with most not completing planned therapy, it is not powered for meaningful statistical results.

Results Point of Contact

Title
Lymphoma/Myeloma Disease Oriented Team
Organization
University of Wisconsin Carbone Cancer Center
barnstable@wisc.edu
608-265-3794

Study Officials

  • Brad S Kahl, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 28, 2007

Study Start

January 25, 2005

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

December 13, 2019

Results First Posted

July 13, 2018

Record last verified: 2018-07

Locations

US(1)