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 ]
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