Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma
Marginal Zone Lymphoma
Drug: Ibritumomab Tiuxetan
|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|
- 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.
- 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.
|Study Start Date:||February 2006|
|Study Completion Date:||February 2015|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Experimental: Zevalin + Rituximab
Ibritumomab Tiuxetan (Zevalin) + 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: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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453102
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center - Miami|
|Miami, Florida, United States, 33136|
|Study Chair:||Izidore S. Lossos, MD||University of Miami Sylvester Comprehensive Cancer Center|