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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Non-Hodgkin Lymphoma

Intervention / Treatment
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* Drug: Rituximab
* Drug: Cyclophosphamide
* Drug: Doxorubicin
* Drug: Vincristine
* Drug: Prednisone
* Drug: Fludarabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rituximab<br>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. | Drug: Rituximab<br>* Rituximab SC 1400 mg<br>* Other names: MabThera®;Drug: Cyclophosphamide<br>* Cyclophosphamide will be administered as per standard local practice.<br>* Other names: Endoxan;Drug: Doxorubicin<br>* Doxorubicin will be administered as per standard local practice.<br>Drug: Vincristine<br>* Vincristine will be administered as per standard local practice.<br>Drug: Prednisone<br>* Prednisone will be administered as per standard local practice.<br>Drug: Fludarabine<br>* Fludarabine will be administered as per standard local practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 8 months]) | 
| 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 8 months]) | 
| Overall Survival (OS) |  | From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 8 months]) | 
| 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 8 months]) | 
| 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 8 months]) | 
| Healthcare Professional Questionnaire Score |  | End of treatment (Month 24 for FL participants and Month 8 for DLBCL participants) | 
| Patient-Reported Rituximab Administration Questionnaire (RASQ) Score |  | FL participants: Baseline, end of induction treatment/early termination (ET) (up to 8 months), end of maintenance treatment/ET (up to 24 months); DLBCL participants: Baseline, end of treatment/ET (up to 8 months) |