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Rituximab Therapy in Follicular Lymphoma in Combination With Chemotherapy - REFLECT 1

NCT ID: NCT02461290

Last Updated: 2015-09-30

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

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2013-11-30

Brief Summary

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The primary objective is to evaluate the safety profile and tolerability of rituximab in combination with different chemotherapy regimens.

Detailed Description

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Conditions

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Follicular Lymphoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Combination Therapy

Rituximab 375mg/m2, on day 1 of each cycle of chemotherapy, total of 8 infusions. Chemotherapy according to standard regimens.

Chemotherapy

Intervention Type RADIATION

Rituximab

Intervention Type DRUG

Interventions

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Chemotherapy

Intervention Type RADIATION

Rituximab

Intervention Type DRUG

Other Intervention Names

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MabThera

Eligibility Criteria

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Inclusion Criteria

* New diagnosed Stage III/IV NHLs
* Grades 1, 2 follicular lymphoma need to be treated
* mCD20 positive
* Have an expected survival of 3 months or more
* ECOG 0-2 grade
* Normal renal function
* ALT less than double normal level

Exclusion Criteria

* Presence of CNS lymphoma
* Severe infectious disease or organic disease
* Having another malignant tumor
* Pregnant or breast-feeding female
* Organic heart disease, heart failure, II or higher grade AV bundle block.
* Subject is allergic to Rituximab
* Known HIV infection or chronic HBV infection
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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Belgrade, , Serbia

Site Status

Belgrade, , Serbia

Site Status

Kamenitz, , Serbia

Site Status

Kragujevac, , Serbia

Site Status

Niš, , Serbia

Site Status

Novi Sad, , Serbia

Site Status

Countries

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Serbia

Other Identifiers

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ML21526

Identifier Type: -

Identifier Source: org_study_id