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

NCT ID: NCT01987505

Last Updated: 2018-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-11
• Study Completion Date: 2017-04-11

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subcutaneous Rituximab

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.

Group Type: EXPERIMENTAL

Rituximab

Intervention Type: DRUG

1400 mg will be injected subcutaneously (SC).

Interventions

Rituximab

1400 mg will be injected subcutaneously (SC).

Intervention Type: DRUG

Other Intervention Names

MabThera; Rituxan

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Hospital De Txagorritxu; Servicio de Hematologia

Vitoria-Gasteiz, Alava, Spain

Hospital General de Elda; Servicio de Hematologia

Elda, Alicante, Spain

Hospital Son Llatzer; Servicio de Hematologia

Palma de Mallorca, Balearic Islands, Spain

Hospital de Granollers, Servicio de Hematología

Granollers, Barcelona, Spain

Hospital Mutua de Terrassa; Servicio de Hematologia

Terrassa, Barcelona, Spain

Hospital General de Castellon; Servicio de Hematologia

Castellon, Castellon, Spain

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

A Coruña, LA Coruña, Spain

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

Santiago de Compostela, LA Coruña, Spain

Complejo Hospitalario San Millan - San Pedro; Servicio Hematologia

Logroño, La Rioja, Spain

Complejo Asistencial de León, Servicio de Hematología

León, LEON, Spain

Hospital Universitario de Fuenlabrada; Servicio de Hematologia

Fuenlabrada, Madrid, Spain

Hospital Severo Ochoa; Servicio de Hematologia

Leganés, Madrid, Spain

Hosital Universitario de Mostoles;Servicio de Hematologia

Móstoles, Madrid, Spain

Clinica Universitaria de Navarra; Servicio de Hematologia

Pamplona, Navarre, Spain

Hospital de Navarra, Servicio de Hematología

Pamplona, Navarre, Spain

Complejo Hospitalario Universitario de Vigo; Servicio de Hematologia

Vigo, Pontevedra, Spain

Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia

Santa Cruz de Tenerife, Tenerife, Spain

Hospital de Basurto; Servicio de Hematologia

Bilbao, Vizcaya, Spain

Hospital de Galdakano; Servicio de Hematologia

Galdakao, Vizcaya, Spain

Complejo Hospitalario Torrecardenas; Servicio de Hematologia

Almería, , Spain

Hospital Universitario de Burgos, Servicio de Hematología

Burgos, , Spain

Hospital Universitario Reina Sofia; Servicio de Hematologia

Córdoba, , Spain

Hospital Universitario Virgen de las Nieves; Servicio de Hematologia

Granada, , Spain

Hospital Universitario de Gaudalajara; Hematología

Guadalajara, , Spain

Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Hematologia

Lleida, , Spain

Hospital Infanta Leonor; Servicio de Hematologia

Madrid, , Spain

Fundacion Jimenez Diaz; Servicio de Hematologia

Madrid, , Spain

Hospital Universitario Clínico San Carlos; Servicio de Hematología

Madrid, , Spain

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

Madrid, , Spain

Hospital Universitario Puerta de Hierro; Servicio de Hematologia

Madrid, , Spain

Hospital Universitario Principe de Asturias; Servicio de Hematología

Madrid, , Spain

Hospital Univ. Virgen de la Victoria

Málaga, , Spain

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

Murcia, , Spain

Hospital Universitario Virgen de Arrixaca; Servicio de Hematologia

Murcia, , Spain

Complejo Hospitalario de Pontevedra; Servicio de Hematologia

Pontevedra, , Spain

Complejo Asistencial de Segovia

Segovia, , Spain

Hospital Universitario Virgen Macarena; Servicio de Hematologia

Seville, , Spain

Hospital Univ. Nuestra Señora de Valme; Servicio de Hematologia

Seville, , Spain

Hospital de Rio Hortega; Servicio de Hematologia

Valladolid, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 35126524 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31573078 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2013-001118-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ML28943

Identifier Type: -

Identifier Source: org_study_id