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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 October 2021
• Main ID: NCT02406092
• Date of registration: 23/03/2015
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: Safety Study of Rituximab (SC) Administered in Participants With CD20+ DLBCL or CD20+ Follicular NHL Grade 1 to 3A
• Scientific title: 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
• Date of first enrolment: October 13, 2015
• Target sample size: 122
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02406092
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Algeria, Morocco, Tunisia

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Non-Hodgkin Lymphoma

Intervention(s)

Drug: Doxorubicin

Drug: Rituximab

Drug: Cyclophosphamide

Drug: Fludarabine

Drug: Prednisone

Drug: Vincristine

Primary Outcome(s)

Percentage of Participants With Administration-Associated Reactions (AARs) [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 Outcome(s)

Patient-Reported Rituximab Administration Questionnaire (RASQ) Score [Time Frame: 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)]

Disease-Free Survival (DFS) as Assessed by Investigator According to IWG Response Criteria [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 8 months])]

Percentage of Participants With CR/CRu as Assessed by Investigator According to IWG Response Criteria [Time Frame: From first dose of rituximab 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 [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 8 months])]

Event-Free Survival (EFS) as Assessed by Investigator According to International Working Group (IWG) Response Criteria [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 8 months])]

Healthcare Professional Questionnaire Score [Time Frame: End of treatment (Month 24 for FL participants and Month 8 for DLBCL participants)]

Overall Survival (OS) [Time Frame: From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 8 months])]

Secondary ID(s)

ML28964

Source(s) of Monetary Support

Please refer to primary and secondary sponsors