Rituximab
DrugRituximab SC 1400 mg
Other names: MabThera®
NCT Number: NCT02406092
This open-label, single-arm study will evaluate the safety of rituximab subcutaneously (SC) administered during first line treatment for follicular non-Hodgkin's lymphoma (NHL) (Induction and/or Maintenance treatment plus 24 months of follow up), or diffuse large B-cell lymphoma (DLBCL) (treatment plus 24 months of follow-up).
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Phase 3
Hôpital Dorban CHU Annaba, Service d'Hématologie, Annaba, Algeria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Rituximab SC 1400 mg
Other names: MabThera®
Cyclophosphamide will be administered as per standard local practice.
Other names: Endoxan
Doxorubicin will be administered as per standard local practice.
Vincristine will be administered as per standard local practice.
Prednisone will be administered as per standard local practice.
Fludarabine will be administered as per standard local practice.
Time frame: Within 24 hours of each rituximab SC administration (maximum treatment duration up to 32 months for FL participants and up to 8 months for DLBCL participants)
AARs defined as all related adverse events (AEs) occurring within 24 hours of rituximab SC administration, including infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof.
Time frame: From first dose of rituximab intravenous (IV) and SC until first occurrence of progression or relapse (up to end of induction treatment [Up to 53.8 Months])
EFS is defined as the time from first dose of rituximab (analysed using both first dose of IV and first dose of SC) to first occurrence of progression or relapse, according to the IWG response criteria or other country standards, or initiation of a non-protocolspecified anti-lymphoma therapy or death, whichever occurs first.
Time frame: From first dose of rituximab IV and SC until first occurrence of progression or relapse (up to end of induction treatment [Up to 53.8 Months])
PFS is defined as the time from first dose of rituximab (analysed using both first dose of IV and first dose of SC) to the first occurrence of progression or relapse, according to the IWG response criteria (Cheson et al. 1999) or other country standards, or death from any cause.
Time frame: From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [Up to 51.1 Months])
OS is defined as the time from first dose of rirtuximab (analysed using both first dose of IV and first dose of SC) until death from any cause.
Time frame: From the date of the initial complete response (CR)/complete response unconfirmed (CRu) until date of relapse or death from any cause (up to end of induction treatment [Up to 32.7 Months])
DFS will be assessed at the end of induction treatment in patients achieving CR/CRu and is defined as the period from the date of the initial CR/CRu until the date of relapse or death from any cause.
Time frame: From first dose of rituximab until first occurrence of progression or relapse (up to end of induction treatment [Up to 32 Months])
CR/CRu: Response assessments 4 - 6 weeks after the last dose of induction treatment will be based on the Investigator's assessment, completed according to the original International Working Group (IWG) response criteria for response assessment of lymphoma (Cheson et al. 1999).
Time frame: End of treatment (Month 24 for FL participants and Month 8 for DLBCL participants)
Planned Healthcare Professional Questionnaiere was not collected during the study therefore no data to report
Time frame: Up to 53.8 Months
The RASQ measures the overall participant satisfaction and is a 20-item questionnaire measuring the impact of the treatment administration on 5 domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction.
Each question's answer is chosen from 1 (minimum)-5(maximum score indicating less severity) score range.
For each domain was scored using the following formula:
Domain score = [(Sum of completed item (question) responses / Number of completed items) - 1] x 100 / (Maximum possible item response value - Minimum possible item response value)
The final RASQ domains is calculated using the formula:
RASQ domain score = (Mean of completed item responses - 1) x 25, scores ranging from 1-100 with higher scores indicative of more positive feelings toward therapy. Lower number representing lower satisfaction and higher is the higher satisfaction by the participants.
Hoffmann-La Roche
Industry
An Open-Label, Multinational, Multicenter, Phase IIIB Study to Assess Safety of Rituximab Following Subcutaneous Administration in Patients With CD20+ DLBCL or CD20+ Follicular NHL Grade 1 to 3A
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03713580
Hemic and Lymphatic Diseases, Immune System Diseases
Cleveland, Ohio, United States
View Trial DetailsNCT04000880
Adnexal Diseases, Behavior
Birmingham, Alabama, United States
View Trial DetailsNCT03570892
Hemic and Lymphatic Diseases, Immune System Diseases
La Jolla, California, United States
View Trial DetailsNCT05169658
Grade 1 Follicular Lymphoma, Grade 2 Follicular Lymphoma
Seattle, Washington, United States
View Trial Details