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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Izidore Lossos, University of Miami
ClinicalTrials.gov Identifier:
NCT00453102
First received: March 27, 2007
Last updated: November 30, 2015
Last verified: November 2015
  Purpose
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: Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.
  Eligibility

Ages Eligible for Study:   18 Years to 120 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453102

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

Publications:
Responsible Party: Izidore Lossos, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT00453102     History of Changes
Other Study ID Numbers: 20060078  SCCC-2005133  WIRB-20060249 
Study First Received: March 27, 2007
Results First Received: October 23, 2015
Last Updated: November 30, 2015
Health Authority: United States: Food and Drug Administration

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
MZL
Non-gastric extranodal MZL
Splenic MZL
Nodal MZL
Gastric MZL

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Antibodies, Monoclonal
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on February 11, 2016