- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00689845
Combination Chemotherapy and Rituximab in Treating Patients With Primary Mediastinal Diffuse Large B-Cell Lymphoma
A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma (IELSG 26)
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving rituximab together with one of five different combination chemotherapy regimens may kill more cancer cells.
PURPOSE: This clinical trial is studying giving rituximab together with combination chemotherapy to see how well it works in treating patients with primary mediastinal diffuse large B-cell lymphoma.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
- Droga: ciclofosfamida
- Droga: metotrexato
- Droga: clorhidrato de doxorrubicina
- Droga: sulfato de vincristina
- Droga: prednisona
- Biológico: sulfato de bleomicina
- Biológico: filgrastim
- Droga: prednisolona
- Droga: ifosfamida
- Droga: fosfato de etopósido
- Droga: citarabina
- Droga: vindesina
- Biológico: rituximab
Descripción detallada
OBJECTIVES:
Primary
- To systematically analyze the phenotype and molecular characteristics in patients with primary mediastinal diffuse large B-cell lymphoma.
- To determine the PET response rate following chemoimmunotherapy in these patients.
Secondary
- To obtain data, on a nonrandomized basis, regarding the outcomes of treatment using different chemoimmunotherapy regimens and using or omitting mediastinal radiotherapy, depending upon the practice of the participating institutions.
- To analyze progression-free and overall survival in patients treated with these regimens.
OUTLINE: This is a multicenter study.
Patients receive any one of the following standard chemoimmunotherapy regimens.
- Cohort 1 (R-CHOP-21): Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
- Cohort 2 (R-CHOP-14): Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, oral prednisolone on days 1-5, and filgrastim (G-CSF) subcutaneously (SC) on days 5-12. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
- Cohort 3 (R-MACOP-B): Patients receive rituximab IV on days 1, 22, 43, 64, 85, and 106; cyclophosphamide IV and doxorubicin hydrochloride IV on days 1, 15, 29, 43, 57, and 71; methotrexate IV on days 8, 36, and 64; vincristine IV on days 8, 22, 36, 50 ,64, and 78; bleomycin IV on days 22, 50, and 78; and oral prednisolone on days 1-84, followed by a taper.
- Cohort 4 (R-VACOP-B): Patients receive rituximab IV on days 1, 22, 43, 64, 85, and 106; cyclophosphamide IV on days 1, 29, and 57; doxorubicin hydrochloride IV on days 1, 15, 29, 43, 57, and 71; etoposide phosphate IV on days 15, 16, 43, 44, 71, and 72; vincristine IV and bleomycin IV on days 8, 22, 36, 50, 64, and 78; and oral prednisolone on days 1-84, followed by a taper.
- Cohort 5 (R-ACVBP): Patients receive rituximab IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1; vindesine IV and bleomycin IV on days 1 and 5; oral prednisone on days 1-5; methotrexate intrathecally on day 2; and G-CSF SC on days 6-13 for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of 4 courses of R-ACVBP, patients receive consolidation therapy comprising high-dose methotrexate IV, rituximab IV, ifosfamide IV, etoposide phosphate IV, and cytarabine SC according to protocol GELA LNH03-2B.
Patients with an International Prognostic Index score of 4 or greater or disease in close proximity to the spinal cord or cerebral meninges may receive prophylactic treatment to the CNS according to local protocol.
Beginning 8 weeks after completion of chemoimmunotherapy, patients undergo radiotherapy to the original tumor volume according to local protocol.
Fresh or fixed tissue from prior biopsy is obtained if possible. Samples are analyzed for CD3, CD20, CD30, CD15, CD10, Bcl-6, Bcl-2, MAL protein (if available), and Ki-67 via immunohistochemistry.
After completion of study treatment, patients are followed periodically.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
London, Reino Unido
- Reclutamiento
- Saint Bartholomew's Hospital
-
Contacto:
- Contact Person
- Número de teléfono: 44-207-796-3979
- Correo electrónico: silvia.montoto@cancer.org.uk
-
-
England
-
Leeds, England, Reino Unido, LS9 7TF
- Reclutamiento
- Leeds Cancer Centre at St. James's University Hospital
-
London, England, Reino Unido, SW17 0QT
- Reclutamiento
- St. George's Hospital
-
Contacto:
- Contact Person
- Número de teléfono: 44-208-725-2425
- Correo electrónico: rpetteng@sghms.ac.uk
-
Manchester, England, Reino Unido, M20 4BX
- Reclutamiento
- Christie Hospital
-
Contacto:
- Contact Person
- Número de teléfono: 44-845-226-3000
-
Northwood, England, Reino Unido, HA6 2RN
- Reclutamiento
- Mount Vernon Cancer Centre at Mount Vernon Hospital
-
Contacto:
- Contact Person
- Número de teléfono: 44-1923-826-111
-
Sheffield, England, Reino Unido, S1O 2SJ
- Reclutamiento
- Cancer Research Centre at Weston Park Hospital
-
Contacto:
- Contact Person
- Número de teléfono: 44-114-226-5007
- Correo electrónico: b.w.hancock@sheffield.ac.uk
-
Southampton, England, Reino Unido, SO16 6YD
- Reclutamiento
- Southampton General Hospital
-
Contacto:
- Contact Person
- Número de teléfono: 44-238-079-6186
- Correo electrónico: johnsonp@soton.ac.uk
-
Sutton, England, Reino Unido, SM2 5PT
- Reclutamiento
- Royal Marsden - Surrey
-
Contacto:
- Contact Person
- Número de teléfono: 44-208-661-3279
- Correo electrónico: david.cunningham@rmh.nhs.uk
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
Histologically confirmed primary mediastinal diffuse large B-cell lymphoma
- CD20-positive disease
- Any stage of disease
- Must have a dominant mass within the anterior mediastinum
PATIENT CHARACTERISTICS:
- ANC ≥ 1.5 x 10^9/L (unless due to lymphoma)
- Platelets ≥ 100 x 10^9/L (unless due to lymphoma)
- WBC ≥ 3.0 x 10^9/L (unless due to lymphoma)
- Serum creatinine ≤ 2 times upper limit of normal (ULN) (unless due to lymphoma)
- AST/ALT ≤ 2.5 times ULN (unless due to lymphoma)
- Total bilirubin ≤ 2.5 times ULN (unless due to lymphoma)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Must be fit to receive chemotherapy with curative intent
No evidence of clinically significant cardiac disease* within the past 12 months, including any of the following:
- Symptomatic ventricular arrhythmias
- Congestive heart failure
- Myocardial infarction NOTE: * Cardiac compromise due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease.
- No known HIV infection
- No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Able and willing to give informed consent and to undergo staging, including PET scanning
PRIOR CONCURRENT THERAPY:
- No prior treatment for lymphoma
- Prior corticosteroids for up to 1 week allowed for the relief of local compressive symptoms
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Cohort 1
Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1.
Patients also receive oral prednisolone on days 1-5.
Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
Dado IV
Dado IV
Dado IV
Administrado oralmente
dado IV
|
Experimental: Cohort 2
Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, oral prednisolone on days 1-5, and filgrastim (G-CSF) subcutaneously (SC) on days 5-12.
Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
|
Dado IV
Dado IV
Dado IV
Administrado por vía subcutánea
Administrado oralmente
dado IV
|
Experimental: Cohort 3
Patients receive rituximab IV on days 1, 22, 43, 64, 85, and 106; cyclophosphamide IV and doxorubicin hydrochloride IV on days 1, 15, 29, 43, 57, and 71; methotrexate IV on days 8, 36, and 64; vincristine IV on days 8, 22, 36, 50 ,64, and 78; bleomycin IV on days 22, 50, and 78; and oral prednisolone on days 1-84, followed by a taper.
|
Dado IV
Dado IV
Dado IV
Dado IV
Dado IV
Administrado oralmente
dado IV
|
Experimental: Cohort 4
Patients receive rituximab IV on days 1, 22, 43, 64, 85, and 106; cyclophosphamide IV on days 1, 29, and 57; doxorubicin hydrochloride IV on days 1, 15, 29, 43, 57, and 71; etoposide phosphate IV on days 15, 16, 43, 44, 71, and 72; vincristine IV and bleomycin IV on days 8, 22, 36, 50, 64, and 78; and oral prednisolone on days 1-84, followed by a taper.
|
Dado IV
Dado IV
Dado IV
Dado IV
Administrado oralmente
Dado IV
dado IV
|
Experimental: Cohort 5
Patients receive rituximab IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1; vindesine IV and bleomycin IV on days 1 and 5; oral prednisone on days 1-5; methotrexate intrathecally on day 2; and G-CSF SC on days 6-13 for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of 4 courses of R-ACVBP, patients receive consolidation therapy comprising high-dose methotrexate IV, rituximab IV, ifosfamide IV, etoposide phosphate IV, and cytarabine SC according to protocol GELA LNH03-2B.
|
Dado IV
Dado IV
Dado IV
Administrado oralmente
Dado IV
Administrado por vía subcutánea
Dado IV
Dado IV
Administrado por vía subcutánea
Dado IV
dado IV
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
---|
Complete response rate on PET scanning at the completion of chemoimmunotherapy
|
Medidas de resultado secundarias
Medida de resultado |
---|
Supervivencia libre de progresión
|
Muerte
|
Tiempo de supervivencia
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Peter Johnson, MD, University Hospital Southampton NHS Foundation Trust
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- Linfoma difuso de células grandes en adultos en estadio III
- Linfoma difuso de células grandes en adultos en estadio IV
- Linfoma difuso de células grandes en adultos no contiguos en estadio II
- Linfoma difuso de células grandes en adultos contiguos en estadio II
- Linfoma difuso de células grandes en adultos en estadio I
Términos MeSH relevantes adicionales
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Enfermedades linfáticas
- Trastornos inmunoproliferativos
- Linfoma
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Agentes Antivirales
- Inhibidores de la síntesis de ácidos nucleicos
- Inhibidores de enzimas
- Agentes antiinflamatorios
- Agentes antirreumáticos
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Glucocorticoides
- Hormonas
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Agentes Antineoplásicos Hormonales
- Agentes antineoplásicos, alquilantes
- Agentes alquilantes
- Agonistas mieloablativos
- Agentes antineoplásicos, fitogénicos
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Agentes antineoplásicos inmunológicos
- Agentes dermatológicos
- Antibióticos, Antineoplásicos
- Agentes de control reproductivo
- Agentes abortivos, no esteroideos
- Agentes abortivos
- Antagonistas del ácido fólico
- Prednisolona
- Ciclofosfamida
- Etopósido
- Fosfato de etopósido
- Ifosfamida
- Rituximab
- Prednisona
- Doxorrubicina
- Doxorrubicina liposomal
- Citarabina
- Metotrexato
- Vincristina
- Bleomicina
- Vindesina
Otros números de identificación del estudio
- CDR0000588011
- USCTU-IELSG-26-RHM-CAN0546
- EU-20818
- EudraCT 2006-005794-22
- USCTU-07/Q1704/68
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .