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

This study has been completed.
Information provided by (Responsible Party):
Izidore Lossos, University of Miami Identifier:
First received: March 27, 2007
Last updated: November 30, 2015
Last verified: November 2015
Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).

Condition Intervention Phase
Marginal Zone Lymphoma
Drug: Rituximab
Drug: Ibritumomab Tiuxetan
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Ibritumomab Tiuxetan (Zevalin®) in Patients With Previously Untreated Marginal Zone Lymphoma

Resource links provided by NLM:

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Enrollment: 18
Study Start Date: February 2006
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Zevalin

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.

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00453102

United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Study Chair: Izidore S. Lossos, MD University of Miami Sylvester Comprehensive Cancer Center
  More Information

Responsible Party: Izidore Lossos, Professor, University of Miami Identifier: NCT00453102     History of Changes
Other Study ID Numbers: 20060078
SCCC-2005133 ( Other Identifier: University of Miami Sylvester Comprehensive Cancer Center )
WIRB-20060249 ( Other Identifier: Western Institutional Review Board )
Study First Received: March 27, 2007
Results First Received: October 23, 2015
Last Updated: November 30, 2015

Keywords provided by University of Miami:
Marginal Zone Lymphoma
Non-gastric extranodal Marginal Zone Lymphoma
Splenic Marginal Zone Lymphoma
Nodal Marginal Zone Lymphoma
Gastric Marginal Zone Lymphoma
Non-gastric extranodal MZL
Splenic MZL
Nodal MZL
Gastric MZL

Additional relevant MeSH terms:
Lymphoma, B-Cell, Marginal Zone
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on April 28, 2017