Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Ma… (NCT00453102) | Clinical Trial Compass
CompletedPhase 2
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma
United States18 participantsStarted 2006-02
Plain-language summary
Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥ 18 years old with previously untreated, histologically confirmed Marginal Zone Lymphoma (non-gastric extranodal MZL, splenic MZL and nodal MZL) or gastric MZL that did not respond to antibiotic therapy given up to 6 months prior to enrollment, but not less than 2 months)
* Measurable and evaluable disease
* All stages are eligible
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (Appendix B)
* Willing and able to provide written informed consent
* Women of childbearing potential must have a negative pregnancy test at study entry and must agree to use effective contraception while on treatment and for 6 months after treatment
* Life expectancy of at least 6 months
Exclusion Criteria:
* Prior chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids, or systemic biologic anticancer therapy before beginning study treatment.
* ≥ 25% lymphoma bone marrow involvement
* Platelet count \< 100,000 cells/mm³
* Neutrophil count \< 1,500 cells/mm³
* Known history of HIV infection
* Pregnant or lactating (pregnancy test is required for all female patients of childbearing potential)
* Woman of childbearing potential or sexually active man unwilling to use adequate contraceptive protection.
* Physical or mental condition that makes patient unable to complete specified follow-up assessments
What they're measuring
1
Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy.