Safety Study of Rituximab (SC) Administered in Participants With CD20+ DLBCL or CD20+ Follicular NHL Grade 1 to 3A

Hoffmann-La Roche139 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

139

Conditions

Non-Hodgkin Lymphoma

Interventions

RituximabDRUG

Rituximab SC 1400 mg

CyclophosphamideDRUG

Cyclophosphamide will be administered as per standard local practice.

DoxorubicinDRUG

Doxorubicin will be administered as per standard local practice.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically confirmed, cluster of differentiation (CD)20+ DLBCL or CD20+ follicular NHL grade 1 to 3a, according to the world health organization (WHO) classification system * Currently being treated with rituximab IV in the Induction or Maintenance setting, having received at least one full dose of rituximab IV, defined as standard full dose of rituximab IV 375 milligrams per square meter (mg/m\^2) administered without interruption or early discontinuation because of tolerability issues * Expectation and current ability for the participants to receive at least four additional cycles of treatment during the Induction phase or six additional cycles of treatment during the Maintenance phase (participants with follicular NHL) Exclusion Criteria: * Transformed lymphoma or FL IIIB * History of other malignancy that could affect compliance with the protocol or interpretation of results. This includes a malignancy that has been treated but not with curative intent, unless the malignancy has been in remission without treatment for greater than or equal to (\>/=) 5 years prior to dosing

Locations (13)

Hôpital Dorban CHU Annaba, Service d'Hématologie

Annaba, Algeria

EHS CAC Hospital FRANTZ FANON ZABANA BLIDA; Hematology ward

Blida, Algeria

EHU Oran, Service d'Hématologie et de Thérapie Cellulaire

Outcomes

Primary Outcomes

Percentage of Participants With Administration-Associated Reactions (AARs)

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: 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)

Secondary Outcomes

Event-Free Survival (EFS) as Assessed by Investigator According to International Working Group (IWG) Response Criteria

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 intravenous (IV) and SC until first occurrence of progression or relapse (up to end of induction treatment [Up to 53.8 Months])

Progression-Free Survival (PFS) as Assessed by Investigator According to IWG Response Criteria

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 first occurrence of progression or relapse (up to end of induction treatment [Up to 53.8 Months])

Overall Survival (OS)

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 first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [Up to 51.1 Months])

Data from ClinicalTrials.gov

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Vincristine will be administered as per standard local practice.

PrednisoneDRUG

Prednisone will be administered as per standard local practice.

FludarabineDRUG

Fludarabine will be administered as per standard local practice.

Centre hospitalo-univerisitaire de Tizi Ouzou - Nedir Mohamed;Service d'hématologie

Tizi Ouzou, Algeria

CHU 20 Aout Service D'Onco-Hematologie Pediatrique

Casablanca, Morocco

Clinique AlMadina; Service hematologie

Casablanca, Morocco

Centre Hospitalier Uni Ire de Marrakech; Oncologie-Hématologie

Marrakesh, Morocco

Hôpital d'enfants de Rabat - Service d'hémato-oncologie pédiatrique

Rabat, Morocco

CHU Fattouma Bourguiba, Monastir; Service d'hématologie

Monastir, Tunisia

CHU Hédi Chacker; Service d'hématologie

Sfax, Tunisia

...and 3 more locations

Disease-Free Survival (DFS) as Assessed by Investigator According to IWG Response Criteria

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 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])

Percentage of Participants With CR/CRu as Assessed by Investigator According to IWG Response Criteria

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: From first dose of rituximab until first occurrence of progression or relapse (up to end of induction treatment [Up to 32 Months])

Healthcare Professional Questionnaire Score

Planned Healthcare Professional Questionnaiere was not collected during the study therefore no data to report

Time frame: End of treatment (Month 24 for FL participants and Month 8 for DLBCL participants)

Patient-Reported Rituximab Administration Questionnaire (RASQ) Score

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.

Time frame: Up to 53.8 Months