Clinical trial NCT00453102: Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma
Official title: Phase II Study of Ibritumomab Tiuxetan (Zevalin®) in Patients With Previously Untreated Marginal Zone Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Marginal Zone Lymphoma
Keywords: Marginal Zone Lymphoma
Non-gastric extranodal Marginal Zone Lymphoma
Splenic Marginal Zone Lymphoma
Nodal Marginal Zone Lymphoma
Gastric Marginal Zone Lymphoma
MZL
Non-gastric extranodal MZL
Splenic MZL
Nodal MZL
Gastric MZL
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2007-03-28
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).

Detailed description: 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.

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

Primary outcomes:
measure: Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy.
timeFrame: 12 weeks post-therapy
Secondary outcomes:
measure: Rate of Progression-Free Survival
timeFrame: End of study.
measure: 5-Year Rate of Progression-Free Survival (5-Year PFS)
timeFrame: 5 Years
measure: Overall Survival (OS) Rate
timeFrame: End of Study
measure: 5 Year Rate of Overall Survival (5-Year OS)
timeFrame: 5 Years
measure: Number of Participants With Unacceptable Toxicity.
timeFrame: Up to 12 weeks post-therapy
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Center - Miami
state: Florida
Study officials:
affiliation: University of Miami Sylvester Comprehensive Cancer Center
name: Izidore S. Lossos, MD
role: STUDY_CHAIR
References:
citation: Lossos IS, Fabregas JC, Koru-Sengul T, Miao F, Goodman D, Serafini AN, Hosein PJ, Stefanovic A, Rosenblatt JD, Hoffman JE. Phase II study of (90)Y Ibritumomab tiuxetan (Zevalin) in patients with previously untreated marginal zone lymphoma. Leuk Lymphoma. 2015 Jun;56(6):1750-5. doi: 10.3109/10428194.2014.975801. Epub 2014 Nov 20.