HIGH-DOSE CHEMOTHERAPY FOLLOWED BY AUTOLOGOUS PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR CHILDREN WITH RELAPSED ACUTE LYMPHOCYTIC LEUKEMIA
filgrastim
+ sargramostim
+ carmustine
Enfermedades Hematológicas+7
+ Enfermedades hemáticas y linfáticas
+ Enfermedades del sistema inmunitario
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de marzo de 1995
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the efficacy of autologous peripheral blood stem cell (PBSC) transplantation for marrow reconstitution after high-dose carmustine, cytarabine, etoposide, and cyclophosphamide in children with relapsed acute lymphocytic leukemia. Determine the dose effect of autologous PBSC on engraftment in this patient population. OUTLINE: Patients receive chemotherapy mobilization comprising cytarabine IV every 12 hours on days 1-5. When blood counts recover, autologous peripheral blood stem cells (PBSC) are harvested and selected for mononuclear cells, granulocyte-macrophage colony-forming units, and CD34+ cells. Patients receive preparative regimen comprising carmustine IV on days -8 and -3, cytarabine IV every 12 hours and etoposide IV every 12 hours on days -7 to -4, and cyclophosphamide IV on days -2 and -1. PBSC are reinfused on day 0. Patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) beginning after PBSC transplantation. Male patients undergo radiotherapy to the testes before transplantation. Patients with a history of CNS leukemia undergo craniospinal irradiation before transplantation. Patients are followed at 100 days, 6 months, and 1 year. PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 5 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 30 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 1 a 19 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
Criterios
DISEASE CHARACTERISTICS: Diagnosis of acute lymphoblastic leukemia Pathologic evidence of relapse in marrow, CNS, or testes In second or later complete remission Ineligible for allogeneic transplantation: No suitable allogeneic donor (sibling or family donor or unrelated donor with no more than 1 HLA-A or -B antigen mismatch and HLA-DR identical) OR Ineligible for preparative regimen including total-body irradiation Peripheral blood stem cell collection feasible: Patient size generally at least 8 kg Able to place central venous catheter Patient cooperative PATIENT CHARACTERISTICS: Age: 1 to 19 Performance status: Not moribund Life expectancy: No severe limits from disease other than leukemia Hepatic: Bilirubin no greater than 3 times normal for age AST and/or GGT no greater than 3 times normal for age No evidence of hepatic synthetic dysfunction Renal: GFR at least 50% of normal based on Glofil study or 12-hour creatinine clearance Cardiovascular: Cardiac contractility normal on echocardiogram Pulmonary: FVC and FEV_1 with or without DLCO at least 50% predicted Other: No significant active infection HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy See Disease Characteristics Surgery Not specified
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
University of Nebraska Medical Center
Omaha, United StatesAbrir University of Nebraska Medical Center en Google Maps