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

NCT02472756 | Completed Results

• 1 other identifier: ML21872
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 6

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.

Conditions

Lymphoma, Follicular

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With Objective Response

  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)

  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

  Year 2

Study Arms (1)

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; Drug: Rituximab

Interventions

Chemotherapy DRUG

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.

Follicular Lymphoma Participants

Rituximab DRUG

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.

Also known as: MabThera

Follicular Lymphoma Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Previously treated adult participants with relapsed/refractory FL

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (6)

Institute of Hematology

Belgrade, 11000, Serbia

Location

Clinical Center Bezanijska Kosa

Belgrade, 11070, Serbia

Location

Institute For Oncology Sremska Kamenica; Internal Medicine Department

Kamenitz, 21204, Serbia

Location

Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

Clinic of Haematology Cc Nis

Niš, 18000, Serbia

Location

Clinical Center Vojvodine; Clinic for Hematology

Novi Sad, 21000, Serbia

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Drug Therapy; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 16, 2015
• Study Start: September 19, 2008
• Primary Completion: May 30, 2014
• Study Completion: May 30, 2014
• Last Updated: August 1, 2017
• Results First Posted: August 12, 2016

Record last verified: 2017-06

Locations

SE (6)