Comparing Interleukin-2 (IL-2) Combined With Rituximab (Rituxan) to Rituximab Alone in Subjects With Non-Hodgkin's Lymphoma (NHL)

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to determine whether interleukin-2 given 3 times weekly for 8 weeks in combination with rituximab is effective and safe when compared to rituximab given alone in the treatment of follicular NHL subjects that have never received rituximab as a treatment and are refractory or relapsed after previous chemotherapy.

Detailed Description

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Conditions

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Non-Hodgkin Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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interleukin-2

Intervention Type DRUG

rituximab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* CD20+ follicular B-cell non-hodgkin's lymphoma with at least 1 site of measurable disease.
* Previous treatment with 1 to 4 prior chemotherapy regimens
* ECOG performance status of greater than or equal to 2
* Life expectancy of greater than 18 weeks
* Meet safety lab requirements and organ function tests

Exclusion Criteria

* Prior treatment with rituximab or IL-2
* Prior radioimmunotherapy including Zevalin or Bexxar
* 5 or more prior chemotherapy regimens
* Clinically significant cardiac disease, lung dysfunction, autoimmune disease, thyroid disease, active infection, unstable psychiatric condition, or HIV infection.
* History of allogenic bone marrow transplant
* Female subjects that are pregnant or breast feeding
* Immunosuppressive therapy including corticosteroids or investigational agents within 4 weeks prior to the planned start of study treatment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Countries

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United States

Other Identifiers

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IL2NHL006

Identifier Type: -

Identifier Source: org_study_id