A Comparative, Randomized, Parallel-group, Multi-center, ... | EligiMed

A Comparative, Randomized, Parallel-group, Multi-center, Phase IIIB Study to Investigate the Efficacy of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With CHOP (R-CHOP) in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma (DLBCL)

CompletadoFase 3ClinicalTrials.gov

ID: NCT01649856Tipo: INTERVENTIONALInicio: 24 de ago de 2012Fin estimado: 16 de sept de 2016

Traducción no disponible, mostrando original

Resumen

This multicenter, randomized, open label parallel-group study will evaluate the efficacy and safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8 cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study treatment is 6 months.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Adult patients, \>/= 18 and \</= 80 years of age at time of study inclusion
Histologically confirmed, previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL) according to the WHO classification system
Patients with an International Prognostic Index (IPI) score 1-5, or IPI score 0 with bulky disease, defined as one lesion \>/= 7.5 cm
At least one bi-dimensionally measurable lesion defined as \>/= 1.5 cm in its largest dimension on CT scan, PET-CT scan or MRI
Adequate hematologic function
Eastern Cooperative Oncology Group (EOCD) performance status \</= 2

Criterios de exclusión

Primary or secondary central nervous system lymphoma, histologic evidence of transformation to Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, primary cutaneous DLBCL, or primary DLBCL of the testis
Transformed lymphoma or follicular lymphoma IIIB
Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation
History of other malignancy, except for curatively treated basal or squamous cell carcinoma or melanoma of the skin, carcinoma in situ of the cervix, or a malignancy that has been treated without curative intent and has been in remission without treatment for \>/= 5 years prior to enrolment
Inadequate renal or hepatic function
Known human immunodeficiency virus (HIV) infection or HIV seropositive status
Active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection. Patients with occult or prior HBV infection as defined by protocol may be included. Patients positive for HCV antibody are eligible only if polymerase chain reaction testing for HCV ribonucleic acid is negative.
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
Prior treatment with cytotoxic drugs or rituximab for another condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody
Pregnant or lactating women

Intervenciones

drug

CHOP

CHOP chemotherapy: cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone; 6 or 8 cycles

drug

rituximab [MabThera/Rituxan]

The first rituximab dose will be administered intravenously on Day of Cycle 1 at a dose of 375 mg/m2. Subsequent doses of 1400 mg are administered subcutaneously on Day 1 of each cycle, for a further 7 cycles

drug

rituximab [MabThera/Rituxan]

375 mg/m2 intravenously on Day 1 of each cycle, 8 cycles

Ubicaciones

Cemic; Haematology

Buenos Aires, Argentina

Hospital Privado de Comunidad; Oncology

Mar del Plata, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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