Completed

Prospective, Non Interventional Study to Evaluate the Safety Profile of First- Line Rituximab Maintenance Therapy in Patients With Follicular Non-Hodgkin's Lymphoma

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What is being collected

Drug Data

Collected from today forward - Prospective
Drug
Who is being recruted

Hemic and Lymphatic Diseases+6

+ Immune System Diseases

+ Immunoproliferative Disorders

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: October 2012
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: December 29, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: October 22, 2012

Actual date on which the first participant was enrolled.

This prospective observational study will evaluate the safety and efficacy of first-line rituximab maintenance therapy in participants with follicular non-Hodgkin's lymphoma. Participants initiated on rituximab maintenance therapy according to the standard of care and in line with the current summary of product characteristics will be followed for a maximum of 3 years or until disease progression occurs.

NCT01684865
Principal SponsorHoffmann-La Roche
Last updated: December 29, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

22 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLymphoma, Non-Hodgkin

Criteria

3 inclusion criteria required to participate
Complete or partial response to first-line induction therapy with chemotherapy with rituximab
Histological diagnosis of follicular non-Hodgkin's lymphoma
Participants about to receive first-line rituximab maintenance treatment for follicular non-Hodgkin's lymphoma according to the local label
5 exclusion criteria prevent from participating
Any medical or psychological alteration that, to criterion of the investigator, can jeopardize the capacity of the participant to grant informed consent
Central nervous system involvement
Hepatitis B or C virus infection or human immunodeficiency virus infection
Pregnant or lactating women
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University Clinic of Hematology Skopje, Hospital Care Department

Skopje, North MacedoniaOpen University Clinic of Hematology Skopje, Hospital Care Department in Google Maps
CompletedOne Study Center