MabRella Study: A Study to Evaluate the Safety of Switching From Intravenous to Subcutaneous Administration of Rituximab During First-Line Treatment for Lymphoma

NCT01987505 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: ML289432013-001118-14
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 39

Brief Summary

This open-label, single-arm, phase IIIb study will evaluate the safety of switching from intravenous (IV) to subcutaneous (SC) administration of rituximab during first-line treatment for participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) who have already received at least one full dose of rituximab IV. Participants with FL will be given 1400 mg rituximab SC during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). 1400 mg SC of rituximab will be given to participants with DLBCL once monthly for 4-7 cycles. Treatment duration is expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.

Conditions

Lymphoma, Non Hodgkin

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Administration-Associated Reactions (AARs)

  AARs were defined as all adverse events (AEs) occurring within 24 hours of rituximab SC administration and which were considered related to study drug. AARs included infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof. Grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.

  From start of treatment to end of treatment (up to 32 months)

Secondary Outcomes (8)

• Percentage of Participants With At Least One Grade >/= 3 Adverse Events (AEs)

  From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)

• Percentage of Participants With At Least One Grade >/= 3 Infusion/ Injection Related Reactions (IIRRs)

  From start of treatment to end of treatment (up to 32 months)

• Percentage of Participants With At Least One Serious Adverse Event (SAE)

  From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)

• Event-Free Survival (EFS)

  From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)

• Progression-Free Survival (PFS)

  From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)

Study Arms (1)

Subcutaneous Rituximab

EXPERIMENTAL

Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab will be treated with subcutaneous (SC) rituximab. Participants with FL will be administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL will be administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration is expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.

Drug: Rituximab

Interventions

Rituximab DRUG

1400 mg will be injected subcutaneously (SC).

Also known as: MabThera, Rituxan

Subcutaneous 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:

• Age ≥ 18 and ≤ 80 years at time of enrolment.
• Life expectancy ≥ 6 months.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3.
• Fertile men or women of childbearing potential must use effective contraception until at least 12 months after the last dose; women must not be pregnant.
• Histologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL) or CD20+ follicular Non-Hodgkin Lymphoma (FL) grade 1, 2 or 3a according to the World Health Organisation Classification system.
• Induction only:
• Participants with Follicular Lymphoma should meet Groupe D'Etude des Lymphomes Folliculaires (GELF) criteria to initiate treatment.
• At least tumor \>/= 1.5 cm as measured by computed tomography (CT) scan.
• FL treatment-related criteria
• \- Currently being treated with rituximab IV during first-line therapy and has received at least one full dose of rituximab IV.

You may not qualify if:

• Transformed lymphoma.
• Primary central nervous system lymphoma, primary effusion lymphoma, primary mediastinal DLBCL, DLBCL of the testis, primary cutaneous DLBCL or histologic evidence of transformation to a Burkitt lymphoma.
• History of other cancer, including one that has been treated but not with curative intent, unless the cancer has been in remission without treatment for \>/= 5 years prior to dosing. Note: Participants with a history of cured skin cancer or in situ carcinoma of the cervix are eligible for the study.
• Ongoing corticosteroid use \> 30 mg/day of prednisone or equivalent. Note: Participants receiving corticosteroid treatment with \</= 30 mg/day of prednisone or equivalent must be on a stable regimen for at least 4 weeks prior to start of dosing.
• Inadequate renal, hematologic, or hepatic function.
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products.
• For participants with DLBCL: Contraindication to any of the individual components of CHOP (cyclophosphamide, vincristine, doxorubicin and prednisone), including prior anthracycline treatment.
• For participants with FL: contraindication to standard chemotherapy.
• Other serious underlying medical conditions.
• Recent major surgery (within 4 weeks prior to dosing), other than for diagnosis.
• Active and/or severe infections (excluding nail fungal infections) or any infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to dosing.
• Active Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection. Note: Participants testing positive for Hepatitis B or C virus antibodies but with an undetectable viral load may be included.
• History of Human Immunodeficiency Virus (HIV) positive status.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (39)

Hospital De Txagorritxu; Servicio de Hematologia

Vitoria-Gasteiz, Alava, 01009, Spain

Location

Hospital General de Elda; Servicio de Hematologia

Elda, Alicante, 03600, Spain

Location

Hospital Son Llatzer; Servicio de Hematologia

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

Hospital de Granollers, Servicio de Hematología

Granollers, Barcelona, 08400, Spain

Location

Hospital Mutua de Terrassa; Servicio de Hematologia

Terrassa, Barcelona, 08221, Spain

Location

Hospital General de Castellon; Servicio de Hematologia

Castellon, Castellon, 12004, Spain

Location

Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Hematologia

A Coruña, LA Coruña, 15006, Spain

Location

Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Hematologia

Santiago de Compostela, LA Coruña, 15706, Spain

Location

Complejo Hospitalario San Millan - San Pedro; Servicio Hematologia

Logroño, La Rioja, 26006, Spain

Location

Complejo Asistencial de León, Servicio de Hematología

León, LEON, 24008, Spain

Location

Hospital Universitario de Fuenlabrada; Servicio de Hematologia

Fuenlabrada, Madrid, 28943, Spain

Location

Hospital Severo Ochoa; Servicio de Hematologia

Leganés, Madrid, 28911, Spain

Location

Hosital Universitario de Mostoles;Servicio de Hematologia

Móstoles, Madrid, 28935, Spain

Location

Clinica Universitaria de Navarra; Servicio de Hematologia

Pamplona, Navarre, 31008, Spain

Location

Hospital de Navarra, Servicio de Hematología

Pamplona, Navarre, 31008, Spain

Location

Complejo Hospitalario Universitario de Vigo; Servicio de Hematologia

Vigo, Pontevedra, 36204, Spain

Location

Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia

Santa Cruz de Tenerife, Tenerife, 38010, Spain

Location

Hospital de Basurto; Servicio de Hematologia

Bilbao, Vizcaya, 48013, Spain

Location

Hospital de Galdakano; Servicio de Hematologia

Galdakao, Vizcaya, 48960, Spain

Location

Complejo Hospitalario Torrecardenas; Servicio de Hematologia

Almería, 04009, Spain

Location

Hospital Universitario de Burgos, Servicio de Hematología

Burgos, 09006, Spain

Location

Hospital Universitario Reina Sofia; Servicio de Hematologia

Córdoba, 14004, Spain

Location

Hospital Universitario Virgen de las Nieves; Servicio de Hematologia

Granada, 18014, Spain

Location

Hospital Universitario de Gaudalajara; Hematología

Guadalajara, 19002, Spain

Location

Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Hematologia

Lleida, 25198, Spain

Location

Hospital Infanta Leonor; Servicio de Hematologia

Madrid, 28031, Spain

Location

Fundacion Jimenez Diaz; Servicio de Hematologia

Madrid, 28040, Spain

Location

Hospital Universitario Clínico San Carlos; Servicio de Hematología

Madrid, 28040, Spain

Location

HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio Hematologia

Madrid, 28050, Spain

Location

Hospital Universitario Puerta de Hierro; Servicio de Hematologia

Madrid, 28222, Spain

Location

Hospital Universitario Principe de Asturias; Servicio de Hematología

Madrid, 28805, Spain

Location

Hospital Univ. Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital General Universitario J.M Morales Meseguer; Servicio de Hematología

Murcia, 30008, Spain

Location

Hospital Universitario Virgen de Arrixaca; Servicio de Hematologia

Murcia, 30120, Spain

Location

Complejo Hospitalario de Pontevedra; Servicio de Hematologia

Pontevedra, 36071, Spain

Location

Complejo Asistencial de Segovia

Segovia, 40002, Spain

Location

Hospital Universitario Virgen Macarena; Servicio de Hematologia

Seville, 41009, Spain

Location

Hospital Univ. Nuestra Señora de Valme; Servicio de Hematologia

Seville, 41014, Spain

Location

Hospital de Rio Hortega; Servicio de Hematologia

Valladolid, 47010, Spain

Location

Related Publications (2)

• Petrini M, Gaidano G, Mengarelli A, Consoli U, Santoro A, Liberati AM, Ladetto M, Fraticelli V, Guarini A, Mannina D, Ferrando P, Corradini P, Musto P, Stelitano C, Marino D, Camera A, Murineddu M, Battistini R, Caparrotti G, Turrini M, Arcaini L, Santini S, Cerqueti M, Ferreri AJM, Cantore N, Inzoli A, Cardinale G, Ronci B, La Nasa G, Massimi S, Gaglione G, Barbiero V, Martelli M. Safety and Efficacy of Subcutaneous Rituximab in Previously Untreated Patients with CD20+ Diffuse Large B-Cell Lymphoma or Follicular Lymphoma: Results from an Italian Phase IIIb Study. Adv Hematol. 2022 Jan 27;2022:5581772. doi: 10.1155/2022/5581772. eCollection 2022.

  PMID: 35126524 DERIVED

• Garcia-Munoz R, Quero C, Perez-Persona E, Domingo-Garcia A, Perez-Lopez C, Villaescusa-de-la-Rosa T, Martinez-Castro AM, Arguinano-Perez JM, Parra-Cuadrado JF, Panizo C. Safety of switching from intravenous to subcutaneous rituximab during first-line treatment of patients with non-Hodgkin lymphoma: the Spanish population of the MabRella study. Br J Haematol. 2020 Mar;188(5):661-673. doi: 10.1111/bjh.16227. Epub 2019 Oct 1.

  PMID: 31573078 DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Rituximab

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

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-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: November 8, 2013
• First Posted: November 19, 2013
• Study Start: November 11, 2013
• Primary Completion: April 11, 2017
• Study Completion: April 11, 2017
• Last Updated: December 26, 2018
• Results First Posted: July 5, 2018

Record last verified: 2018-12

Locations

ES (39)