Suspendido

Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab, or Rituximab and G3139 Phosphorothioate Oligonucleotide (BCL-2 Antisense - NSC-683428) Therapy for Young Patients (< Age 60) With Advanced Stage Diffuse Large B-Cell NHL of Low and Low-Intermediate IPI Risk

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

oblimersen sodium

+ rituximab

+ cyclophosphamide

BiológicoMedicamentoOtro
Quiénes están siendo reclutados

Enfermedades del sistema inmunitario+5

+ Trastornos Inmunoproliferativos

+ Enfermedades Linfáticas

De 19 a 59 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 2
Intervencional
Inicio del estudio: marzo de 2004
Ver detalles del protocolo

Resumen

Patrocinador PrincipalNational Cancer Institute (NCI)
Última actualización: 14 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de marzo de 2004

Fecha en la que se inscribió al primer participante.

PRIMARY OBJECTIVES: I. To estimate the 1-year progression-free survival probability rate in younger patients with low and low-intermediate IPI risk advanced stage diffuse large B-cell NHL treated with 8-cycles of CHOP-rituximab. (The CHOP-rituximab arm of this study was permanently closed, effective 10/15/04.) II. To estimate the 1-year progression-free survival probability rate in younger patients with low and low-intermediate IPI risk advanced stage diffuse large B-cell NHL treated with 8 cycles of CHOP-rituximab-G3139. III. To evaluate response (complete, complete unconfirmed, and partial) and toxicity for these regimens in this patient population. (The CHOP-rituximab arm of this study was permanently closed, effective 10/15/04.) IV. To estimate the 1-year progression-free survival and response rate in the subset of patients overexpressing bcl-2 protein. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age-adjusted International Prognostic Index (0 vs 1). Patients are randomized to 1 of 2 treatment arms. (Arm I closed to accrual as of 9/21/04.) ARM I (closed to accrual as of 9/21/04): Patients receive rituximab IV over 6 hours, cyclophosphamide IV over 15-45 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1 and oral prednisone on days 1-5. ARM II: Patients receive oblimersen IV continuously on days 1-7; rituximab IV over 6 hours, cyclophosphamide IV over 15-45 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 5; and oral prednisone on days 5-10. In both arms, treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for up to 5 years.

Título OficialStandard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab, or Rituximab and G3139 Phosphorothioate Oligonucleotide (BCL-2 Antisense - NSC-683428) Therapy for Young Patients (< Age 60) With Advanced Stage Diffuse Large B-Cell NHL of Low and Low-Intermediate IPI Risk 
NCT00080847
Patrocinador PrincipalNational Cancer Institute (NCI)
Última actualización: 14 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 160 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 19 a 59 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Enfermedades del sistema inmunitarioTrastornos InmunoproliferativosEnfermedades LinfáticasLinfomaLinfoma no HodgkinTrastornos LinfoproliferativosNeoplasiasNeoplasias por tipo histológico

Criterios

Inclusion Criteria: * All patients must have previously untreated stage III, IV, or bulky stage II diffuse large B-cell non-Hodgkin's lymphoma which is positive for CD20 * Adequate sections from the original diagnostic specimen must be available for submission for review; an adequate biopsy requires sufficient tissue to establish the architecture and a REAL or WHO histologic subtype with certainty; thus, core biopsies, especially multiple core biopsies MAY be adequate; whereas, needle aspirations or cytologies are not adequate * Patients may also be registered to SWOG-8947 and SWOG-8819 * Patients must have an age-adjusted International Prognostic Index score of 0 or 1 * All patients must have bidimensionally measurable disease documented within 28 days prior to registration; patients with non-measurable disease in addition to measurable disease must have all non-measurable disease assessed within 42 days prior to registration * Patients must have a unilateral bone marrow aspirate and biopsy performed within 42 days prior to registration * Patients must have a CT scan of the chest and abdomen/pelvis performed within 28 days prior to registration * Patients must not have clinical evidence of central nervous system involvement by lymphoma; any laboratory or radiographic tests performed to assess CNS involvement must be negative within 42 days of registration * Patients must not have a previous diagnosis of indolent lymphoma (histologic transformation are ineligible); as patients with nodal diffuse large ell lymphoma may have bone marrow involvement with small lymphocytes, such patients are eligible * Patients must not have received prior chemotherapy, radiation, or antibody therapy for lymphoma * All patients must have a Zubrod performance status of 0-2 * Serum LDH must be measured within 28 days prior to registration * Patients must have a cardiac ejection fraction \>= 45% by MUGA scan or an ECHO with no significant abnormalities within 42 days prior to registration * Patients known to be HIV positive, or who have a history of solid organ transplantation are ineligible as the biology and natural history of HIV associated, or post transplant lymphomas are very different than that of de novo diffuse large cell lymphomas; patients at high risk of hepatitis B virus infection should be screened before initiation of rituximab * Patients requiring continuing supplemental oxygen therapy are ineligible * No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years * Pregnant or nursing women may not participate due to the potential for congenital abnormalities, and of harm to nursing infants due to this treatment regimen; women or men of reproductive potential may no participate unless they have agreed to use an effective contraceptive method * If day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day * In calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered day 28; this allows for efficient patient scheduling without exceeding the guidelines * All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines * At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

2 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Patients receive oblimersen IV continuously on days 1-7; rituximab IV over 6 hours, cyclophosphamide IV over 15-45 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 5; and oral prednisone on days 5-10.

Grupo II

Experimental
Patients receive rituximab IV over 6 hours, cyclophosphamide IV over 15-45 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1 and oral prednisone on days 1-5.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Suspendido

Southwest Oncology Group

San Antonio, United StatesVer ubicación
Suspendido1 Centros de Estudio