Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
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
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
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States
Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy.
The overall response rate (ORR) including complete response (CR), complete response unconfirmed (CRu), and partial response (PR) in participants receiving protocol therapy.
Time frame: 12 weeks post-therapy
Rate of Progression-Free Survival
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.
Time frame: End of study.
5-Year Rate of Progression-Free Survival (5-Year PFS)
Percentage of participants still alive without disease progression five years after the date of protocol therapy initiation.
Time frame: 5 Years
Overall Survival (OS) Rate
The time from the date of initiation of study treatment until date of death from any cause for all participants.
Time frame: End of Study
5 Year Rate of Overall Survival (5-Year OS)
Percentage of participants still alive five years after the date of protocol therapy initiation.
Time frame: 5 Years
Number of Participants With Unacceptable Toxicity.
Number of participants with treatment-related (possible, probable, or definite) grade 3 or higher non-hematologic adverse events.
Time frame: Up to 12 weeks post-therapy
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