A Study of Rituximab in Combination With Chemotherapy in Relapsed/Refractory Follicular Lymphoma (REFLECT 2)

June 26, 2017 updated by: Hoffmann-La Roche

Relapsed/Refractory Follicular Lymphoma - Rituximab Therapy in Combination With Chemotherapy

This is a Phase 4, open, prospective, non-interventional, multicenter trial for previously treated adult participants with relapsed/refractory follicular lymphoma (FL). Eligible participants with FL will receive 6-8 infusions of induction standard regimen of rituximab plus chemotherapy. Participants with complete or partial remission at end of induction will be assigned to maintenance therapy with rituximab once every 3 months for a maximum of 2 years or until relapse. The choice of the treatment regimen will be established on a per center basis, according to the standard in use in the country and in the center, and each center will use the same regimen through the study. Participants will be followed up for safety and efficacy evaluation in accordance with routine practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • Belgrade, Serbia, 11070
        • Clinical Center Bezanijska Kosa
      • Belgrade, Serbia, 11000
        • Institute of Hematology
      • Kragujevac, Serbia, 34000
        • Clinical Center Kragujevac
      • NIS, Serbia, 18000
        • Clinic of Haematology Cc Nis
      • Novi Sad, Serbia, 21000
        • Clinical Center Vojvodine; Clinic for Hematology
      • Sremska Kamenica, Serbia, 21204
        • Institute For Oncology Sremska Kamenica; Internal Medicine Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Previously treated adult participants with relapsed/refractory FL

Description

Inclusion Criteria:

  • Participants diagnosed with FL and had already received one or more treatments

Exclusion Criteria:

  • Participants who are not eligible for rituximab treatment according to summary of product characteristics (SmPC)

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Follicular Lymphoma Participants
Previously treated adult participants with relapsed/refractory FL will receive rituximab in combination with chemotherapy regimen. All treatments prescribed during the observation period will be at the treating physician's discretion. Participants will be followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
Drug: Chemotherapy
The choice of the chemotherapy regimen will be established on a per center basis, according to the standard in use in the country and in the center. Protocol does not specify any particular chemotherapy regimen.
Drug: Rituximab
The choice of the rituximab regimen will be established on a per center basis, according to the standard in use in the country and in the center. Protocol does not specify any particular chemotherapy regimen.
Other Names:
  • MabThera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Objective Response
Time Frame: Baseline until disease progression or death, whichever occurred first (up to approximately 6 months)
Lymphoma response was assessed using Cheson criteria. Objective response was defined as having either complete remission (CR) or partial remission (PR). Criteria for CR (target lesions): Nodes returned to normal (if greatest transverse diameter [GTD] greater than [>] 15 millimeters [mm] before therapy, GTD now less than or equal to [≤] 15 mm; if GTD 11-15 mm and short axis [SA] >10 mm before therapy, SA now ≤10 mm) and all (non-nodal) target lesions completely resolved. Criteria for CR (non-target lesions): All non-target lymph nodes returned to normal size, all extra-nodal lesions have completely resolved, liver and spleen have returned to normal size (if enlarged at baseline). Criteria for PR: Sum of the product of the diameters (SPD) of target lesions decreased at least 50 percent (%) from baseline and spleen and liver nodules regressed by 50% in SPD or single lesion in GTD.
Baseline until disease progression or death, whichever occurred first (up to approximately 6 months)
Percentage of Participants With Complete Remission (CR)
Time Frame: Baseline until disease progression or death, whichever occurred first (up to approximately 6 months)
Lymphoma response was assessed using Cheson criteria. Criteria for CR (target lesions): Nodes returned to normal (if GTD >15 mm before therapy, GTD now ≤15 mm; if GTD 11-15 mm and SA >10 mm before therapy, SA now ≤ 10 mm) and all (non-nodal) target lesions completely resolved. Criteria for CR (non-target lesions): All non-target lymph nodes returned to normal size, all extra-nodal lesions have completely resolved, liver and spleen have returned to normal size (if enlarged at baseline).
Baseline until disease progression or death, whichever occurred first (up to approximately 6 months)
Percentage of Participants Who Were Alive at Year 2
Time Frame: Year 2
Year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2008

Primary Completion (Actual)

May 30, 2014

Study Completion (Actual)

May 30, 2014

Study Registration Dates

First Submitted

May 28, 2015

First Submitted That Met QC Criteria

June 15, 2015

First Posted (Estimate)

June 16, 2015

Study Record Updates

Last Update Posted (Actual)

August 1, 2017

Last Update Submitted That Met QC Criteria

June 26, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML21872

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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