Phase 2
N=18
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma
Marginal Zone Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00453102 ↗Enrolled (actual)
18
Serious AEs
12.5%
Results posted
Jan 2016
Primary outcome: Primary: Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy. — 87.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rituximab (Drug); Ibritumomab Tiuxetan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy. |
87.5 | — |
| SECONDARY Rate of Progression-Free Survival |
47.6 | — |
| SECONDARY 5-Year Rate of Progression-Free Survival (5-Year PFS) |
40 | — |
| SECONDARY Overall Survival (OS) Rate |
NA | — |
| SECONDARY 5 Year Rate of Overall Survival (5-Year OS) |
71.8 | — |
| SECONDARY Number of Participants With Unacceptable Toxicity. |
2 | — |
Summary
Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00453102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.