Clinical trial NCT02406092: Safety Study of Rituximab (SC) Administered in Participants With CD20+ DLBCL or CD20+ Follicular NHL Grade 1 to 3A
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Hodgkin Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-04-02
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Administration-Associated Reactions (AARs)
timeFrame: 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:
measure: Event-Free Survival (EFS) as Assessed by Investigator According to International Working Group (IWG) Response Criteria
timeFrame: 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])
measure: Progression-Free Survival (PFS) as Assessed by Investigator According to IWG Response Criteria
timeFrame: 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])
measure: Overall Survival (OS)
timeFrame: From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [Up to 51.1 Months])
measure: Disease-Free Survival (DFS) as Assessed by Investigator According to IWG Response Criteria
timeFrame: 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])
measure: Percentage of Participants With CR/CRu as Assessed by Investigator According to IWG Response Criteria
timeFrame: From first dose of rituximab until first occurrence of progression or relapse (up to end of induction treatment [Up to 32 Months])
measure: Healthcare Professional Questionnaire Score
timeFrame: End of treatment (Month 24 for FL participants and Month 8 for DLBCL participants)
measure: Patient-Reported Rituximab Administration Questionnaire (RASQ) Score
timeFrame: Up to 53.8 Months
Other outcomes:
Locations:
city: Annaba
country: Algeria
facility: Hôpital Dorban CHU Annaba, Service d'Hématologie
city: Blida
country: Algeria
facility: EHS CAC Hospital FRANTZ FANON ZABANA BLIDA; Hematology ward
city: Oran
country: Algeria
facility: EHU Oran, Service d'Hématologie et de Thérapie Cellulaire
city: Tizi Ouzou
country: Algeria
facility: Centre hospitalo-univerisitaire de Tizi Ouzou - Nedir Mohamed;Service d'hématologie
city: Casablanca
country: Morocco
facility: CHU 20 Aout Service D'Onco-Hematologie Pediatrique
city: Casablanca
country: Morocco
facility: Clinique AlMadina; Service hematologie
city: Marrakech
country: Morocco
facility: Centre Hospitalier Uni Ire de Marrakech; Oncologie-Hématologie
city: Rabat
country: Morocco
facility: Hôpital d'enfants de Rabat - Service d'hémato-oncologie pédiatrique
city: Monastir
country: Tunisia
facility: CHU Fattouma Bourguiba, Monastir; Service d'hématologie
city: Sfax
country: Tunisia
facility: CHU Hédi Chacker; Service d'hématologie
city: Sousse
country: Tunisia
facility: CHU Farhat Hached; Service d'hématologie
city: Tunis
country: Tunisia
facility: Aziza Othmana Hospital; Clinical Haematology
city: Tunis
country: Tunisia
facility: Hopital Militaire d'instruction de Tunis; Service d'hématologie
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: