Back to resultsYttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma
Primary Purpose
Marginal Zone Lymphoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rituximab
Ibritumomab Tiuxetan
Sponsored by
About this trial
This is an interventional treatment trial for Marginal Zone Lymphoma focused on measuring 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
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
Sites / Locations
- University of Miami Sylvester Comprehensive Cancer Center - Miami
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Zevalin + Rituximab
Arm Description
Ibritumomab Tiuxetan (Zevalin) + Rituximab
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Overall Survival (OS) Rate
The time from the date of initiation of study treatment until date of death from any cause for all participants.
5 Year Rate of Overall Survival (5-Year OS)
Percentage of participants still alive five years after the date of protocol therapy initiation.
Number of Participants With Unacceptable Toxicity.
Number of participants with treatment-related (possible, probable, or definite) grade 3 or higher non-hematologic adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00453102
Brief Title
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
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zevalin + Rituximab
Arm Type
Experimental
Arm Description
Ibritumomab Tiuxetan (Zevalin) + Rituximab
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan, IDEC-C2B8, Chimeric anti-CD20 monoclonal antibody
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Ibritumomab Tiuxetan
Other Intervention Name(s)
Zevalin
Intervention Description
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
Primary Outcome Measure Information:
Title
Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy.
Description
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
Secondary Outcome Measure Information:
Title
Rate of Progression-Free Survival
Description
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.
Title
5-Year Rate of Progression-Free Survival (5-Year PFS)
Description
Percentage of participants still alive without disease progression five years after the date of protocol therapy initiation.
Time Frame
5 Years
Title
Overall Survival (OS) Rate
Description
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
Title
5 Year Rate of Overall Survival (5-Year OS)
Description
Percentage of participants still alive five years after the date of protocol therapy initiation.
Time Frame
5 Years
Title
Number of Participants With Unacceptable Toxicity.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Izidore S. Lossos, MD
Organizational Affiliation
University of Miami Sylvester Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Miami Sylvester Comprehensive Cancer Center - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25315074
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.
Results Reference
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Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma
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