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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02472756
Recruitment Status : Completed
First Posted : June 16, 2015
Results First Posted : August 12, 2016
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Lymphoma, Follicular Drug: Chemotherapy Drug: Rituximab

Study Design
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Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Relapsed/Refractory Follicular Lymphoma - Rituximab Therapy in Combination With Chemotherapy
Actual Study Start Date : September 19, 2008
Actual Primary Completion Date : May 30, 2014
Actual Study Completion Date : May 30, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Groups and Cohorts
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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 Name: MabThera


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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).

  3. Percentage of Participants Who Were Alive at Year 2 [ Time Frame: Year 2 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Previously treated adult participants with relapsed/refractory FL
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02472756


Locations
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Serbia
Institute of Hematology
Belgrade, Serbia, 11000
Clinical Center Bezanijska Kosa
Belgrade, Serbia, 11070
Clinical Center Kragujevac
Kragujevac, Serbia, 34000
Clinic of Haematology Cc Nis
NIS, Serbia, 18000
Clinical Center Vojvodine; Clinic for Hematology
Novi Sad, Serbia, 21000
Institute For Oncology Sremska Kamenica; Internal Medicine Department
Sremska Kamenica, Serbia, 21204
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02472756    
Other Study ID Numbers: ML21872
First Posted: June 16, 2015    Key Record Dates
Results First Posted: August 12, 2016
Last Update Posted: August 1, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents