Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma

Marginal Zone Lymphoma Clinical Trial

Official title:

Phase II Study of Ibritumomab Tiuxetan (Zevalin®) in Patients With Previously Untreated Marginal Zone Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00453102
• Other study ID #: 20060078
• Secondary ID: SCCC-2005133WIRB
• Status: Completed
• Phase: Phase 2
• First received: March 27, 2007
• Last updated: November 30, 2015
• Start date: February 2006
• Est. completion date: February 2015

Study information

• Verified date: November 2015
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell, Marginal Zone
• Marginal Zone Lymphoma

Intervention

Drug:
• Rituximab
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
• Ibritumomab Tiuxetan
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

Locations

Country	Name	City	State
United States	University of Miami Sylvester Comprehensive Cancer Center - Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	End of study.	No
Secondary	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.	5 Years	Yes
Secondary	Overall Survival (OS) Rate	The time from the date of initiation of study treatment until date of death from any cause for all participants.	End of Study	No
Secondary	5 Year Rate of Overall Survival (5-Year OS)	Percentage of participants still alive five years after the date of protocol therapy initiation.	5 Years	No
Secondary	Number of Participants With Unacceptable Toxicity.	Number of participants with treatment-related (possible, probable, or definite) grade 3 or higher non-hematologic adverse events.	Up to 12 weeks post-therapy	Yes