- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01355783
A Phase 3 Trial of E7777 in Combination With CHOP Compared With CHOP Alone for the First-Line Treatment of Peripheral T-cell Lymphoma
14 de noviembre de 2013 actualizado por: Eisai Inc.
The purpose of this study is to evaluate whether treatment of E7777 in combination with CHOP has superior efficacy compared with CHOP alone in improving complete response rate (CRR) in first line treatment of subjects with Peripheral T-cell Lymphoma (PTCL).
Descripción general del estudio
Tipo de estudio
Intervencionista
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Illinois
-
Skokie, Illinois, Estados Unidos
-
-
New Jersey
-
Morristown, New Jersey, Estados Unidos
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion:
Subjects must meet all of the following criteria to be included in the study:
- Local pathologic diagnosis of PTCL with the following histology types: PTCL, not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large cell lymphoma (ALCL) (ALK-negative or ALKpositive with IPI ≥ 2).
- Stage II, III or IV disease.
- Tumor lesion(s) measurable in 2 dimensions by computed tomography (CT) and is at least 20 mm in the longest transverse dimension for non-lymph node masses and at least 20 mm in longest transverse dimension for lymph nodes. Subcutaneous masses can be used as indicator lesions. If the lesion was previously irradiated, it must have progressed prior to randomization (by investigator assessment) to be used as a measurable lesion.
- Tumor biopsy available for central pathologic review; may be archived sample from prior biopsy within 6 months of study enrollment, or sample to be obtained on study during screening.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Adequate bone marrow reserve as evidenced by:
- absolute neutrophil count (ANC) ≥ 1000/mm3 (1.0x109/L)
- platelets ≥ 50,000/mm3 (50x109/L); (≥ 25,000/mm3 [25x109/L] allowed if thrombocytopenia secondary to bone marrow involvement by lymphoma)
- hemoglobin ≥ 8 g/dL (80 g/L)
Adequate liver function as evidenced by:
- bilirubin ≤ 1.5 times the upper limit of normal (ULN)
- aspartate aminotransferase (AST [SGOT]) and alanine aminotransferase (ALT [SGPT]) ≤ 3 times the ULN (≤ 5 times the ULN if hepatic involvement)
- albumin ≥ 3.0 g/dL (30 g/L)
- Adequate renal function as evidenced by serum creatinine ≤ 2.0 mg/dL (176 μmol/L) or calculated creatinine clearance ≥ 40 mL/min per the Cockcroft-Gault formula.
- Willing and able to comply with all aspects of the protocol.
- Written informed consent prior to any study-specific screening procedures.
- Female subjects of childbearing potential must have a negative serum betahuman chorionic gonadotropin (β-hCG) pregnancy test at Screening and a negative serum or urine β-hCG pregnancy test result at Baseline, and must agree to use a highly effective method of contraception (see protocol for list) throughout the entire study period and for 30 days after study drug discontinuation.
- Male subjects who are partners of women of childbearing potential must use or their partners must use a highly effective method of contraception (see protocol for list) beginning at least 1 menstrual cycle prior to starting study drug(s),throughout the entire study period, and for 30 days after study drug discontinuation, unless they are sexually abstinent or have undergone a successful vasectomy. Those with partners using hormonal contraceptives must also be using an additional approved method of contraception, as described previously.
Exclusion:
Subjects who meet any of the following criteria will be excluded from the study:
- Diagnosis of ALCL ALK-positive with IPI 0 or 1, adult T-cell leukemia/lymphoma (ATLL), precursor T-cell lymphoblastic lymphoma/leukemia, extranodal NK/TCL nasal type, enteropathy-associated TCL, hepatosplenic TCL, subcutaneous panniculitis-like TCL, and cutaneous T-cell lymphoma (CTCL) including mycosis fungoides and Sezary syndrome.
- Known central nervous system (CNS) involvement with lymphoma.
- Prior chemotherapy, immunotherapy, denileukin diftitox, or investigational agent(s) for this lymphoma, with the exception that a single cycle of CHOP (or CHOP-based therapy) is allowed if the last dose of CHOP (or CHOP-based therapy) was administered ≤ 28 days before study enrollment (Lead-In) or randomization (Main Study).
- Prior radiotherapy for this lymphoma, with the following exception: prior radiation therapy for localized disease ≥ 4 weeks before randomization is allowed as long as the irradiated area is not at the mediastinal area or at the site of the only potentially measurable disease.
- Prior malignancy within past 5 years (except non-melanoma skin cancer or carcinoma in situ of the cervix).
- Serious intercurrent illness.
- Significant cardiac disease requiring ongoing treatment, including congestive heart failure (CHF), severe coronary artery disease (CAD), cardiomyopathy, uncontrolled cardiac arrhythmia, unstable angina pectoris, or myocardial infarction (MI) (within 6 months of study enrollment).
- Left ventricular ejection fraction (LVEF) less than institutional lower limit of normal, as determined by multigated acquisition scan (MUGA) or echocardiogram.
- Major surgery within 2 weeks of study enrollment.
- Active infections requiring specific anti-infective therapy.
- Known human immunodeficiency virus (HIV) infection; known active hepatitis B or hepatitis C infection.
- Deep vein thrombosis within 3 months of study enrollment.
- Females who are pregnant (positive urine test) or breastfeeding.
- Any history of or concomitant medical condition that, in the opinion of the Investigator, would compromise the subject's ability to safely complete the study.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: E7777 + CHOP Chemotherapy
|
Treatment in both arms is for 6 cycles at 21 days/cycle.
|
Comparador activo: CHOP alone
|
Treatment in both arms is for 6 cycles at 21 days/cycle.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
To evaluate whether treatment of E7777 in combination with CHOP chemotherapy has superior efficacy compared with CHOP alone in improving progression-free survival (PFS) in first line treatment of subjects with peripheral T-cell lymphoma
Periodo de tiempo: pre-randomization 4 weeks until disease progression
|
|
pre-randomization 4 weeks until disease progression
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
To evaluate whether E7777 in combination with CHOP treatment has superior efficacy compared with CHOP treatment alone as assessed by overall survival (OS) and by transplant rate.· To compare safety of E7777 in combination with CHOP
Periodo de tiempo: pre-randomization 4 weeks until disease progression
|
|
pre-randomization 4 weeks until disease progression
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Chean Eng Ooi, Eisai Inc.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de marzo de 2011
Finalización primaria (Anticipado)
1 de octubre de 2014
Finalización del estudio (Anticipado)
1 de noviembre de 2014
Fechas de registro del estudio
Enviado por primera vez
16 de mayo de 2011
Primero enviado que cumplió con los criterios de control de calidad
17 de mayo de 2011
Publicado por primera vez (Estimar)
18 de mayo de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
18 de noviembre de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
14 de noviembre de 2013
Última verificación
1 de noviembre de 2013
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- E7777-G000-301
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. .
Ensayos clínicos sobre E7777
-
Eisai Co., Ltd.TerminadoLinfoma cutáneo de células T | Linfoma periférico de células TJapón
-
Eisai Inc.Dr. Reddy's Laboratory; Citius PharmaceuticalsTerminadoLinfoma cutáneo de células T persistente o recurrenteEstados Unidos, Australia, Puerto Rico
-
Masonic Cancer Center, University of MinnesotaReclutamientoLinfoma difuso de células B grandes | DLBCL | Linfoma de células B de alto grado | DLBCL que surge del linfoma folicularEstados Unidos
-
Haider MahdiDr. Reddys Laboratories, SAReclutamientoCáncer epitelial de ovarioEstados Unidos