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

Non-Hodgkin Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02406092
• Other study ID #: ML28964
• Status: Completed
• Phase: Phase 3
• Start date: October 13, 2015
• Est. completion date: June 30, 2021

Study information

• Verified date: September 2021
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma

Intervention

Drug:
• Rituximab
Rituximab SC 1400 mg
• Cyclophosphamide
Cyclophosphamide will be administered as per standard local practice.
• Doxorubicin
Doxorubicin will be administered as per standard local practice.
• Vincristine
Vincristine will be administered as per standard local practice.
• Prednisone
Prednisone will be administered as per standard local practice.
• Fludarabine
Fludarabine will be administered as per standard local practice.

Locations

Country	Name	City	State
Algeria	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	Oran
Algeria	Centre hospitalo-univerisitaire de Tizi Ouzou - Nedir Mohamed;Service d'hématologie	Tizi Ouzou
Morocco	CHU 20 Aout Service D'Onco-Hematologie Pediatrique	Casablanca
Morocco	Clinique AlMadina; Service hematologie	Casablanca
Morocco	Centre Hospitalier Uni Ire de Marrakech; Oncologie-Hématologie	Marrakech
Morocco	CHU Ibn Sina Rabat Service de medecine interne	Rabat
Tunisia	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

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Algeria,  Morocco,  Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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])
Secondary	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])
Secondary	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])
Secondary	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])
Secondary	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])
Secondary	Healthcare Professional Questionnaire Score		End of treatment (Month 24 for FL participants and Month 8 for DLBCL participants)
Secondary	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)