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

Study Overview
=================
Brief 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.

Detailed 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.

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

Conditions
-----------------
Lymphoma, Non-Hodgkin, Lymphoma, Low-Grade

Intervention / Treatment
-----------------
* Drug: ibritumomab tiuxetan (Zevalin®)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ibritumomab tiuxetan (Zevalin®)|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radioimmunotherapy, Antigens, CD20