Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma
|ClinicalTrials.gov Identifier: NCT00453102|
Recruitment Status : Completed
First Posted : March 28, 2007
Results First Posted : January 1, 2016
Last Update Posted : January 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Marginal Zone Lymphoma||Drug: Rituximab Drug: Ibritumomab Tiuxetan||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Ibritumomab Tiuxetan (Zevalin®) in Patients With Previously Untreated Marginal Zone Lymphoma|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|