Safety Study of Rituximab (SC) Administered in Participants With CD20+ DLBCL or CD20+ Follicular NHL Grade 1 to 3A
- Conditions
- Non-Hodgkin Lymphoma
- Interventions
- Registration Number
- NCT02406092
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 139
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rituximab Rituximab Participants with FL and DLBCL will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction. Rituximab Cyclophosphamide Participants with FL and DLBCL will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction. Rituximab Doxorubicin Participants with FL and DLBCL will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction. Rituximab Vincristine Participants with FL and DLBCL will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction. Rituximab Prednisone Participants with FL and DLBCL will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction. Rituximab Fludarabine Participants with FL and DLBCL will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Administration-Associated Reactions (AARs) 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.
- Secondary Outcome Measures
Name Time Method Event-Free Survival (EFS) as Assessed by Investigator According to International Working Group (IWG) Response Criteria 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.
Progression-Free Survival (PFS) as Assessed by Investigator According to IWG Response Criteria 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.
Overall Survival (OS) 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.
Disease-Free Survival (DFS) as Assessed by Investigator According to IWG Response Criteria 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.
Percentage of Participants With CR/CRu as Assessed by Investigator According to IWG Response Criteria 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).
Healthcare Professional Questionnaire Score 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
Patient-Reported Rituximab Administration Questionnaire (RASQ) Score 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.
Trial Locations
- Locations (13)
Hôpital d'enfants de Rabat - Service d'hémato-oncologie pédiatrique
🇲🇦Rabat, Morocco
HĂ´pital Dorban CHU Annaba, Service d'HĂ©matologie
🇩🇿Annaba, Algeria
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-HĂ©matologie
🇲🇦Marrakech, Morocco
CHU Fattouma Bourguiba, Monastir; Service d'hématologie
🇹🇳Monastir, Tunisia
CHU Hédi Chacker; Service d'hématologie
🇹🇳Sfax, Tunisia
CHU Farhat Hached; Service d'hématologie
🇹🇳Sousse, Tunisia
Aziza Othmana Hospital; Clinical Haematology
🇹🇳Tunis, Tunisia
Hopital Militaire d'instruction de Tunis; Service d'hématologie
🇹🇳Tunis, Tunisia
EHS CAC Hospital FRANTZ FANON ZABANA BLIDA; Hematology ward
🇩🇿Blida, Algeria
EHU Oran, Service d'Hématologie et de Thérapie Cellulaire
🇩🇿Oran, Algeria