A Study of Rituximab in Combination With Chemotherapy in Relapsed/Refractory Follicular Lymphoma

Completed

• Conditions: Lymphoma, Follicular
• Interventions: Drug: Chemotherapy; Drug: Rituximab

• Registration Number: NCT02472756
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-19
• Primary Completion: 2014-05-30
• Study Completion: 2014-05-30
• Study First Submitted: 2015-05-28
• Study First Submitted QC: 2015-06-15
• Study First Posted: 2015-06-16
• Results First Submitted: 2016-05-11
• Results First Submitted QC: 2016-07-01
• Results First Posted: 2016-08-12
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-26
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Follicular Lymphoma Participants	Chemotherapy	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.
Follicular Lymphoma Participants	Rituximab	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Complete Remission (CR)	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).
Percentage of Participants Who Were Alive at Year 2	Year 2
Percentage of Participants With Objective Response	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.

Trial Locations

Locations (6)

Institute of Hematology; 🇷🇸 Belgrade, Serbia

Clinical Center Kragujevac; 🇷🇸 Kragujevac, Serbia

Clinic of Haematology Cc Nis; 🇷🇸 NIS, Serbia

Clinical Center Bezanijska Kosa; 🇷🇸 Belgrade, Serbia

Institute For Oncology Sremska Kamenica; Internal Medicine Department; 🇷🇸 Sremska Kamenica, Serbia

Clinical Center Vojvodine; Clinic for Hematology; 🇷🇸 Novi Sad, Serbia