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

Biogen12 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoma, Non-Hodgkin Lymphoma, Low-Grade

Interventions

ibritumomab tiuxetan (Zevalin®)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Loma Linda University

Loma Linda, California, United States

North County Oncology

Oceanside, California, United States

Medical Specialists of Fairfield

Fairfield, Connecticut, United States

Queens Hospital

Honolulu, Hawaii, United States

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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