Suspendido

A Phase II Study of Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin Plus Asparaginase (DA-EPOCH-A) for Adults With Acute Lymphoblastic Leukemia/Lymphoma

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

Asparaginase

+ Cyclophosphamide

+ Doxorubicin Hydrochloride

MedicamentoOtroBiológico
Quiénes están siendo reclutados

Infecciones por virus ADN+16

+ Linfoma de Burkitt

+ Enfermedades hemáticas y linfáticas

A partir de 18 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 2
Intervencional
Inicio del estudio: julio de 2018
Ver detalles del protocolo

Resumen

Patrocinador PrincipalUniversity of Washington
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de julio de 2018

Fecha en la que se inscribió al primer participante.

PRIMARY OBJECTIVES: I. To determine the efficacy of dose-adjusted etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride plus asparaginase (DA-EPOCH-A) in adults with acute lymphoblastic leukemia/lymphoma (ALL). SECONDARY OBJECTIVES: I. To evaluate the safety and feasibility of this regimen. OUTLINE: Patients receive etoposide, doxorubicin hydrochloride, and vincristine sulfate intravenously (IV) continuously over days 1-4, cyclophosphamide IV over 1 hour on day 5, and prednisone orally (PO) twice daily (BID) on days 1-5. Patients also receive asparaginase intramuscularly (IM) or IV over 1-2 hours every 2-3 days, beginning day 7 of each course. Patients who are cluster of differentiation (CD)20 positive and Philadelphia chromosome negative also receive rituximab IV on day 1 or 5. Patients who are Philadelphia chromosome positive also receive imatinib mesylate PO on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Título OficialA Phase II Study of Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin Plus Asparaginase (DA-EPOCH-A) for Adults With Acute Lymphoblastic Leukemia/Lymphoma
NCT02538926
Patrocinador PrincipalUniversity of Washington
Última actualización: 27 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.

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.

A partir de 18 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

Infecciones por virus ADNLinfoma de BurkittEnfermedades hemáticas y linfáticasInfecciones por HerpesviridaeEnfermedades HematológicasEnfermedades del sistema inmunitarioTrastornos InmunoproliferativosInfeccionesLeucemia LinfocíticaLeucemiaEnfermedades LinfáticasLinfomaLinfoma no HodgkinTrastornos LinfoproliferativosNeoplasiasNeoplasias por tipo histológicoInfecciones por Virus TumoralesEnfermedades ViralesLeucemia-Linfoma Linfoblástica de Células B Precursora

Criterios

Inclusion Criteria: * Patients must have a confirmed diagnosis of either B- or T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma that is either: * Arm A: Initially diagnosed at age 40 or later, OR * Arm B: Relapsed after or failed to respond to \>= 1 previous chemotherapy regimen * The regimen under study must constitute a reasonable therapeutic option * Presence of \>= 5% abnormal blasts in the bone marrow * Patients with prior allogeneic hematopoietic cell transplantation (HCT) must be at least 90 days post-HCT and must be on =\< 20 mg of prednisone (or equivalent dose of an alternative corticosteroid) for treatment/prevention of graft-vs-host disease * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN; unless attributable to Gilbert's disease or other causes of inherited indirect hyperbilirubinemia, at which point total bilirubin must be =\< 2.5 x ULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x institutional ULN * Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the total bilirubin is =\< 3.0 x ULN and ALT/AST are =\< 5.0 x ULN * Creatinine =\< 1.5 mg/dL; however, patients with a creatinine \> 1.5 mg/dL but with a calculated creatinine clearance of \> 60 ml/min, as measured by the Modification of Diet in Renal Disease (MDRD) equation, will be eligible * Measurement of left ventricular ejection fraction (LVEF) should be performed in patients with prior anthracycline exposure or known history of arrhythmia or structural heart disease; in these cases, LVEF must be \>= 40% * As patients with ALL frequently have cytopenias, no hematologic parameters will be required for enrollment or to receive the first cycle of treatment; however, adequate recovery of blood counts will be required to receive subsequent cycles * Per good clinical practice, any toxicity related to prior therapies that, in the opinion of the investigator, would potentially be worsened with DA-EPOCH-A +/- imatinib (imatinib mesylate) +/- rituximab, should be resolved to grade 1 or less * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 * Women of childbearing potential must have a negative pregnancy test and must agree to the use of effective contraception while on treatment; men must also agree to the use of effective contraception while on treatment * Ability to give informed consent and comply with the protocol * Anticipated survival of at least 3 months Exclusion Criteria: * Patients with Burkitt lymphoma/leukemia * Patients must not have received chemotherapy within 14 days of enrollment, with the two following exceptions: * Routine systemic maintenance therapy (e.g., Abelson murine leukemia viral oncogene homolog 1 \[ABL\] kinase inhibitor, methotrexate, 6-mercaptopurine, vincristine, etc.) and intrathecal/intraventricular therapy * Systemic therapy for the acute management of hyperleukocytosis or acute symptoms (e.g., corticosteroids, cytarabine, etc.) * May not have prior malignancies unless the expected survival is at least 2 years * For patients with Philadelphia chromosome positive (Ph+) ALL, they must not have progressed within 3 months of receiving imatinib or have a documented ABL kinase mutation known to confer resistance to imatinib (e.g., T315I) * Patients with persistent grade 2 or higher peripheral sensory or motor neuropathy of any cause * Patients with isolated extramedullary disease or with parenchymal central nervous system (CNS) disease * Known hypersensitivity or intolerance to any of the agents under investigation * Human immunodeficiency virus (HIV) positive or evidence of infection with hepatitis B or C virus, as defined by any of the following criteria (if patients have not previously been tested for the following, these will be conducted during screening): * HIV antibody positive * Hepatitis B surface antigen or core antibody positive * Hepatitis C antibody positive * Other medical or psychiatric conditions that in the opinion of the investigator would preclude safe participation in the protocol * May not be pregnant or nursing

Plan de Estudio

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

Un solo grupo de intervención está designado en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Patients receive etoposide, doxorubicin hydrochloride, and vincristine sulfate IV continuously over days 1-4, cyclophosphamide IV over 1 hour on day 5, and prednisone PO BID on days 1-5. Patients also receive asparaginase IM or IV over 1-2 hours every 2-3 days, beginning day 7 of each course. Patients who are CD20 positive and Philadelphia chromosome negative also receive rituximab IV on day 1 or 5. Patients who are Philadelphia chromosome positive also receive imatinib mesylate PO on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

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

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, United StatesAbrir Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium en Google Maps
Suspendido1 Centros de Estudio