A Study of MabThera/Rituxan (Rituximab) in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma

NCT ID: NCT01998893

Last Updated: 2014-12-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-01-31

Study Completion Date

2008-02-29

Brief Summary

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This study will evaluate the efficacy and safety of MabThera/Rituxan in patients with relapsed low-grade centroblastic centrocytic non-Hodgkin's lymphoma. Patients will receive once-weekly intravenous MabThera/Rituxan for 4 weeks; responding patients will be treated a second time in case of relapse (defined as progression after complete or partial response). The anticipated time on study treatment is \<3 months.

Detailed Description

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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

Study Groups

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MabThera/Rituxan

Group Type EXPERIMENTAL

rituximab [MabThera/Rituxan]

Intervention Type DRUG

375 mg/m2 iv weekly for 4 weeks; for responders to first course of therapy a second course is possible after relapse

Interventions

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rituximab [MabThera/Rituxan]

375 mg/m2 iv weekly for 4 weeks; for responders to first course of therapy a second course is possible after relapse

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients \>= 18 years of age;
* centrocytic centroblastic non-Hodgkin's lymphoma stage III-IV;
* relapse after chemotherapy (with or without interferon maintenance therapy).

Exclusion Criteria

* primary refractory lymphomas;
* more than 3 relapses of centroblastic centrocytic non-Hodgkin's lymphoma;
* clinically significant cardiac disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Cologne, , Germany

Site Status

Erlangen, , Germany

Site Status

Göttingen, , Germany

Site Status

Grenzach-Wyhlen, , Germany

Site Status

Hanover, , Germany

Site Status

Homburg/saar, , Germany

Site Status

München, , Germany

Site Status

München, , Germany

Site Status

Münster, , Germany

Site Status

Stuttgart, , Germany

Site Status

Tübingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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M39004

Identifier Type: -

Identifier Source: org_study_id