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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-01

Study Completion Date

2005-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lymphoma, Non-Hodgkin Lymphoma, Low-Grade

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ibritumomab tiuxetan (Zevalin®)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No