Zevalin® Followed by Rituxan® Maintenance in Previously Treated Low Grade Non-Hodgkin's Lymphoma

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

Zevalin® (Ibritumomab Tiuxetan) Followed by Rituxan® (Rituximab) Maintenance in Previously Treated Low Grade Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00168727
• Other study ID #: 001-03-ZEV
• Secondary ID: Former Biogen Id
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2003
• Est. completion date: October 31, 2005

Study information

• Verified date: August 2023
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and effectiveness of a treatment regimen using Zevalin® plus Rituxan® for patients who have low grade Non-Hodgkin's Lymphoma (NHL) or relapsed Non-Hodgkin's lymphoma and have been previously treated. This study will use an experimental scheduling regimen. No chemotherapy will be used in this study.

Description:

The objective of this study is to determine overall response rate, event-free survival, time-to-progression, time-to-next-therapy, and freedom-from-relapse in patients with low-grade lymphoma in first or second relapse treated with Zevalin followed by 2 years of Rituxan maintenance therapy in a multicenter, community-based setting, as well as evaluate relative response rates in populations with and without prior rituximab therapy, in first versus second relapse, and with and without bulky (> 5 cm in greatest diameter) disease. To meet the initial trial enrollment goal of 300 patients over two years, 42 total sites were activated. The study has subsequently closed to accrual. Currently 8 sites remain active to follow the 12 subjects enrolled in the past year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 31, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Follicular non-Hodgkin's lymphoma including SLL in first or second relapse.
• No anticancer therapy for three wks (six wks if nitrosourea or Mitomycin C); not rituximab refractory.
• Age >= 18 years, not pregnant or lactating.
• Expected survival >= 3 mths; PS 0, 1, or 2.
• ANC >= 1,500/mm3, platelet counts >= 100,000/mm3.
• Total bilirubin > 2.0 mg/dL, creatinine > 2.0 mg/dL.
• Total lymphocyte count < 5,000/mm3 for SLL.
• <25% bone marrow involvement with lymphoma.

Exclusion Criteria:

• Prior ABMT or ASCT, hypocellular or marked reduction in bone marrow precursors, or history of failed stem cell collection.
• Bulky areas of disease more than 10 cm in diameter.
• Patients with CLL, CNS, or mantle cell lymphoma.
• Hx of HIV/AIDS related lymphoma, hepatitis B or C.
• Prior radioimmunotherapy or XRT to >25% of active bone marrow.
• G-CSF or GM-CSF within 2 wks, pegylated G-CSF within 4 wks of treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Low-Grade
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• ibritumomab tiuxetan (Zevalin®)

Locations

Country	Name	City	State
United States	Presbyterian Hospital Cancer Center	Charlotte	North Carolina
United States	Northwest Oncology and Hematology	Elk Grove Village	Illinois
United States	Medical Specialists of Fairfield	Fairfield	Connecticut
United States	Queens Hospital	Honolulu	Hawaii
United States	Horizon Oncolgy Center	Lafayette	Indiana
United States	Loma Linda University	Loma Linda	California
United States	North County Oncology	Oceanside	California
United States	Specialists in Hematology/Oncology	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine overall response rate, event-free survival, time-to-progression, time-to-next-therapy, and freedom-from-relapse in pts with low-grade lymphoma in first or second relapse treated with Zevalin® followed by 2 yrs of Rituxan maintenance therapy
Secondary	Evaluate relative response rates in populations with and without prior rituximab therapy, in first versus second relapse, and with and without bulky (> 5 cm in greatest diameter) disease.