Autologous Bone Marrow Transplantation for Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome - A Phase II Pilot Study
filgrastim
+ busulfan
+ etoposide
Enfermedades de la Médula Ósea+16
+ Enfermedad Crónica
+ Enfermedades Hematológicas
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de octubre de 1999
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the overall survival and disease free survival of patients with acute myelogenous leukemia or myelodysplastic syndrome treated with busulfan and etoposide followed by autologous bone marrow transplantation and filgrastim (G-CSF). Assess the toxicities of this regimen in this patient population. Assess the hematologic effects and toxicities of G-CSF given in this setting to these patients. Determine whether G-CSF stimulates leukemic relapse in these patients. Determine whether G-CSF has an affect on platelet recovery in this setting in these patients. OUTLINE: Patients are stratified according to first, second, or third remission. Patients undergo bone marrow collection. Patients receive oral busulfan every 6 hours for 16 doses on days -5, -4, -3, and -2. Patients receive etoposide IV over 4 hours on days -4, -3, and -2. Bone marrow is reinfused 36-48 hours after the last dose of etoposide. Patients receive filgrastim (G-CSF) IV daily beginning 2-4 hours after bone marrow reinfusion until hematopoietic recovery. Patients are followed monthly for 1 year, every 3 months for 1 year, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 2 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.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.Hasta 65 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: Morphologically proven (from bone marrow aspirate smears or touch preps of marrow biopsy) of myelodysplastic syndrome or acute myelogenous leukemia (AML) of 1 of the following subtypes: Acute myeloblastic leukemia (FAB M1 or M2) Acute promyelocytic leukemia (FAB M3) Acute myelomonocytic leukemia (FAB M4) Acute monocytic leukemia (FAB M5) Acute erythroleukemia (FAB M6) In complete remission at time of marrow or stem cell harvesting No relapsed AML unless bone marrow or peripheral blood stem cells previously harvested in remission are available for transplantation May have had secondary AML that is either therapy related or that has evolved from an antecedent myelodysplastic syndrome History of CNS disease during induction allowed provided inactive and cytologic examination of spinal fluid from preharvest lumbar puncture shows no evidence of leukemia No occult or symptomatic leukemic meningitis during induction therapy or prior to bone marrow harvesting PATIENT CHARACTERISTICS: Age: Physiologic 65 and under Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 50 mL/min Cardiovascular: Cardiac ejection fraction normal Pulmonary: FEV1 at least 60% predicted DLCO at least 60% predicted Other: HIV negative No evidence of persistent infections No concurrent organ damage or medical problems that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No concurrent antibiotics
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
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, United StatesAbrir Robert H. Lurie Comprehensive Cancer Center at Northwestern University en Google Maps