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Completed

NCT Number: NCT00453102

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

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

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Key information

Conditions

Marginal Zone Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab

Drug

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

Ibritumomab tiuxetan

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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. 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2015
Study completion
2015
First posted
Mar 28, 2007
Registry last updated
Jan 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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