A Study of Long-Term Rituximab (MabThera) Maintenance Therapy in Participants With Advanced Follicular Lymphoma

NCT02569996 | Completed Phase 3 Results

• 1 other identifier: ML18167
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 21

Brief Summary

This study will evaluate the efficacy, safety, and tolerability of long-term maintenance therapy with rituximab in participants with advanced follicular lymphoma who have had a positive response to first-line treatment with a rituximab-containing regimen. The anticipated time on study treatment is 2 years, and the target sample size is 124 individuals.

Conditions

Lymphoma, Follicular

Outcome Measures

Primary Outcomes (1)

• Event-free Survival

  Event-free survival (EFS) was defined as the time from baseline (Week 0) to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first. Mean EFS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population (patients who received at least one maintenance MabThera infusion) was used for this analysis.

  From randomization to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first, assessed up to 5 years

Secondary Outcomes (6)

• Number of Participants With Adverse Events (AEs)

  Up to 27 months

• Overall Survival (OS)

  From randomization until death, assessed up to 5 years

• Time to Progression (TTP)

  From baseline (Week 0) to disease progression, relapse, death from the follicular lymphoma or institution of a new regimen, whichever occurs first, assessed up to 5 years

• Time to Next Anti-lymphoma Treatment (TTNLT)

  From baseline (Week 0) to institution of a new antilymphoma regimen, assessed up to 5 years

• Duration of Response (DR)

  From first documented response to induction treatment to relapse or progression or death, assessed up to 5 years

Study Arms (1)

Rituximab

EXPERIMENTAL

Participants will receive rituximab 375 milligrams per meter square (mg/m\^2) every 8 weeks for 24 months or until progression, relapse, death, or institution of a new anti-lymphoma treatment.

Drug: Rituximab

Interventions

Rituximab DRUG

Rituximab will be administered at 375 mg/m\^2 every 8 weeks for 24 months or until progression, relapse, death, or institution of a new anti-lymphoma treatment.

Also known as: MabThera/Rituxan

Rituximab

Eligibility Criteria

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

You may qualify if:

• Adult participants greater than (\>) 18 years of age
• Histologically confirmed follicular lymphoma Grade 1, 2, or 3a with lymph node biopsy within 4 months of induction treatment
• No previous anti-lymphoma treatment before induction chemotherapy (first-line-treated participants only are eligible)
• Verified complete or partial remission after first-line induction therapy including rituximab

You may not qualify if:

• Grade 3b follicular lymphoma
• Transformation to high-grade lymphoma (except to Grade 3a) of previously existing follicular lymphoma
• Presence of central nervous system lymphoma
• Acquired immunodeficiency syndrome-related lymphoma
• Other primary malignancy (other than squamous cell cancer of the skin or in situ cancer of the cervix) for which the participant has not been disease-free for greater than or equal to (\>=) 5 years

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (21)

Unknown Facility

Budapest, 1071, Hungary

Location

Unknown Facility

Budapest, 1083, Hungary

Location

Unknown Facility

Budapest, 1085, Hungary

Location

Unknown Facility

Budapest, 1088, Hungary

Location

Unknown Facility

Budapest, 1122, Hungary

Location

Unknown Facility

Budapest, 1135, Hungary

Location

Unknown Facility

Debrecen, 4032, Hungary

Location

Unknown Facility

Győr, 9024, Hungary

Location

Unknown Facility

Gyula, 5700, Hungary

Location

Unknown Facility

Kaposvár, 7400, Hungary

Location

Unknown Facility

Miskolc, 3529, Hungary

Location

Unknown Facility

Nyíregyháza, 4400, Hungary

Location

Unknown Facility

Pécs, 7624, Hungary

Location

Unknown Facility

Szeged, 6720, Hungary

Location

Unknown Facility

Szekszárd, 7100, Hungary

Location

Unknown Facility

Székesfehérvár, 8000, Hungary

Location

Unknown Facility

Szolnok, 5004, Hungary

Location

Unknown Facility

Szombathely, 9700, Hungary

Location

Unknown Facility

Tatabánya, 2800, Hungary

Location

Unknown Facility

Veszprém, 8200, Hungary

Location

Unknown Facility

Zalaegerszeg, 8900, Hungary

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

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)

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: F. Hoffmann-La Roche AG
• Organization: Roche Trial Information Hotline

global.trial_information@roche.com

+41 61 6878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: October 7, 2015
• Study Start: July 1, 2005
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: December 10, 2015
• Results First Posted: December 10, 2015

Record last verified: 2015-11

Locations

HU (21)