Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma
Phase II Study of Ibritumomab Tiuxetan (Zevalin®) in Patients With Previously Untreated Marginal Zone Lymphoma
3 other identifiers
interventional
18
1 country
1
Brief Summary
Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2006
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 27, 2007
CompletedFirst Posted
Study publicly available on registry
March 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
January 1, 2016
CompletedJanuary 1, 2016
November 1, 2015
9 years
March 27, 2007
October 23, 2015
November 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 weeks post-therapy
Secondary Outcomes (5)
Rate of Progression-Free Survival
End of study.
5-Year Rate of Progression-Free Survival (5-Year PFS)
5 Years
Overall Survival (OS) Rate
End of Study
5 Year Rate of Overall Survival (5-Year OS)
5 Years
Number of Participants With Unacceptable Toxicity.
Up to 12 weeks post-therapy
Study Arms (1)
Zevalin + Rituximab
EXPERIMENTALIbritumomab Tiuxetan (Zevalin) + Rituximab
Interventions
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
Eligibility Criteria
You may qualify if:
- ≥ 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, 33136, United States
Related Publications (1)
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.
PMID: 25315074BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Data reported for only 16 of 18 enrolled participants due to 2 participants withdrawing consent.
Results Point of Contact
- Title
- Izidore S. Lossos
- Organization
- University of Miami
Study Officials
- STUDY CHAIR
Izidore S. Lossos, MD
University of Miami Sylvester Comprehensive Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 27, 2007
First Posted
March 28, 2007
Study Start
February 1, 2006
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
January 1, 2016
Results First Posted
January 1, 2016
Record last verified: 2015-11