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

NCT02406092 | Completed Phase 3 Results

• 1 other identifier: ML28964
• Study Type: interventional
• Target: 139
• Locations: 3 countries
• Sites: 13

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).

Conditions

Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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])

• 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])

• 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])

• 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])

• 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])

Study Arms (1)

Rituximab

EXPERIMENTAL

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; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Fludarabine

Interventions

Rituximab DRUG

Rituximab SC 1400 mg

Also known as: MabThera®

Rituximab

Cyclophosphamide DRUG

Cyclophosphamide will be administered as per standard local practice.

Also known as: Endoxan

Rituximab

Doxorubicin DRUG

Doxorubicin will be administered as per standard local practice.

Rituximab

Vincristine DRUG

Vincristine will be administered as per standard local practice.

Rituximab

Prednisone DRUG

Prednisone will be administered as per standard local practice.

Rituximab

Fludarabine DRUG

Fludarabine will be administered as per standard local practice.

Rituximab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (13)

Hôpital Dorban CHU Annaba, Service d'Hématologie

Annaba, 23000, Algeria

Location

EHS CAC Hospital FRANTZ FANON ZABANA BLIDA; Hematology ward

Blida, 09000, Algeria

Location

EHU Oran, Service d'Hématologie et de Thérapie Cellulaire

Oran, 31000, Algeria

Location

Centre hospitalo-univerisitaire de Tizi Ouzou - Nedir Mohamed;Service d'hématologie

Tizi Ouzou, 15000, Algeria

Location

CHU 20 Aout Service D'Onco-Hematologie Pediatrique

Casablanca, 20100, Morocco

Location

Clinique AlMadina; Service hematologie

Casablanca, 20340, Morocco

Location

Centre Hospitalier Uni Ire de Marrakech; Oncologie-Hématologie

Marrakesh, 40000, Morocco

Location

Hôpital d'enfants de Rabat - Service d'hémato-oncologie pédiatrique

Rabat, 10090, Morocco

Location

CHU Fattouma Bourguiba, Monastir; Service d'hématologie

Monastir, 5000, Tunisia

Location

CHU Hédi Chacker; Service d'hématologie

Sfax, 3025, Tunisia

Location

CHU Farhat Hached; Service d'hématologie

Sousse, 4000, Tunisia

Location

Aziza Othmana Hospital; Clinical Haematology

Tunis, 1008, Tunisia

Location

Hopital Militaire d'instruction de Tunis; Service d'hématologie

Tunis, 1008, Tunisia

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone; fludarabine

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: April 2, 2015
• Study Start: October 13, 2015
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: November 21, 2024
• Results First Posted: November 21, 2024

Record last verified: 2024-11

Locations

MO (4); TU (5); AL (4)