Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma

November 30, 2015 updated by: Izidore Lossos, University of Miami

Phase II Study of Ibritumomab Tiuxetan (Zevalin®) in Patients With Previously Untreated Marginal Zone Lymphoma

Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This phase II study will assess the clinical response rate to Ibritumomab Tiuxetan in patients with untreated nodal, splenic and non-gastric extranodal MZL as well as in antibiotic resistant patients with mucosa-associated lymphoid tissue (MALT) gastric lymphoma.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Sylvester Comprehensive Cancer Center - Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 118 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥ 18 years old with previously untreated, histologically confirmed Marginal Zone Lymphoma (non-gastric extranodal MZL, splenic MZL and nodal MZL) or gastric MZL that did not respond to antibiotic therapy given up to 6 months prior to enrollment, but not less than 2 months)
  • Measurable and evaluable disease
  • All stages are eligible
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (Appendix B)
  • Willing and able to provide written informed consent
  • Women of childbearing potential must have a negative pregnancy test at study entry and must agree to use effective contraception while on treatment and for 6 months after treatment
  • Life expectancy of at least 6 months

Exclusion Criteria:

  • Prior chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids, or systemic biologic anticancer therapy before beginning study treatment.
  • ≥ 25% lymphoma bone marrow involvement
  • Platelet count < 100,000 cells/mm³
  • Neutrophil count < 1,500 cells/mm³
  • Known history of HIV infection
  • Pregnant or lactating (pregnancy test is required for all female patients of childbearing potential)
  • Woman of childbearing potential or sexually active man unwilling to use adequate contraceptive protection.
  • Physical or mental condition that makes patient unable to complete specified follow-up assessments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zevalin + Rituximab
Ibritumomab Tiuxetan (Zevalin) + Rituximab
Drug: Rituximab
IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Other Names:
  • Rituxan
  • IDEC-C2B8
  • Chimeric anti-CD20 monoclonal antibody
Drug: Ibritumomab Tiuxetan

IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:

0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³

Other Names:
  • Zevalin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy.
Time Frame: 12 weeks post-therapy
The overall response rate (ORR) including complete response (CR), complete response unconfirmed (CRu), and partial response (PR) in participants receiving protocol therapy.
12 weeks post-therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Progression-Free Survival
Time Frame: End of study.
The time from the start of protocol therapy until the first documented or confirmed disease progression, or death related to study disease, whichever is earlier.
End of study.
5-Year Rate of Progression-Free Survival (5-Year PFS)
Time Frame: 5 Years
Percentage of participants still alive without disease progression five years after the date of protocol therapy initiation.
5 Years
Overall Survival (OS) Rate
Time Frame: End of Study
The time from the date of initiation of study treatment until date of death from any cause for all participants.
End of Study
5 Year Rate of Overall Survival (5-Year OS)
Time Frame: 5 Years
Percentage of participants still alive five years after the date of protocol therapy initiation.
5 Years
Number of Participants With Unacceptable Toxicity.
Time Frame: Up to 12 weeks post-therapy
Number of participants with treatment-related (possible, probable, or definite) grade 3 or higher non-hematologic adverse events.
Up to 12 weeks post-therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Study Chair: Izidore S. Lossos, MD, University of Miami Sylvester Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

March 27, 2007

First Submitted That Met QC Criteria

March 27, 2007

First Posted (Estimate)

March 28, 2007

Study Record Updates

Last Update Posted (Estimate)

January 1, 2016

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20060078
  • SCCC-2005133 (Other Identifier: University of Miami Sylvester Comprehensive Cancer Center)
  • WIRB-20060249 (Other Identifier: Western Institutional Review Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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