Study to Evaluate the Efficacy of Rituximab in Combination With Low-dose Radiotherapy in Patients With Relapsed Non-Hodgkin's Lymphoma

NCT ID: NCT00147953

Last Updated: 2010-01-27

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

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Brief Summary

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This study aims to assess the short term efficacy of a combination of rituximab and low-dose radiotherapy in patients with non-Hodgkin's lymphoma.

Detailed Description

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Rituximab and low-dose total-nodal irradiation both have shown promising activity in patients with NHL. Moreover, the radiolabelled antibody Zevalin has been approved for the treatment of relapsed NHL. The patients in this study have a poor prognosis. The treatment strategy aims to control the disease and to ameliorate disease related symptoms with minimal toxicity. Both, rituximab and low-dose radiotherapy are associated with minor toxicity if applied alone.

The primary objective of the study is therefore to assess the short term efficacy of a combination of rituximab and low-dose radiotherapy in patients with non-Hodgkin's lymphoma.

Conditions

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Non-Hodgkin's Lymphoma

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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Rituximab

Intervention Type DRUG

Total nodal irradiation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* B-cell non-Hodgkin's lymphoma
* At least one prior antitumor therapy
* ECOG performance status 0-2
* No major organ dysfunction
* Written informed consent

Exclusion Criteria

* The following histologies are excluded: Burkitt's lymphoma, mantle-cell lymphoma, primary CNS-lymphoma, HIV-associated lymphoma
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Principal Investigators

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Andreas Engert

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

R.-P. Mueller

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

Locations

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University of Cologne

Cologne, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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Ritux plus TNI

Identifier Type: -

Identifier Source: org_study_id

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