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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: University of Miami

Current Primary Outcome: 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.


Original Primary Outcome: Clinical response rate (complete response [CR], unconfirmed CR, and partial response)

Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

Information By: University of Miami

Dates:
Date Received: March 27, 2007
Date Started: February 2006
Date Completion:
Last Updated: November 30, 2015
Last Verified: November 2015