The Experimental Treatment of Transfusion Dependent 5q Minus Syndrome With Leucovorin
Leucovorin
Anemia Refractaria+4
+ Enfermedades de la Médula Ósea
+ Enfermedades Hematológicas
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de abril de 1998
Fecha en la que se inscribió al primer participante.The objective of this protocol is to determine whether leucovorin treatment can normalize hematopoietic cell growth and differentiation in patients with 5q- syndrome which may lack the gene for dihydrofolate reductase enzyme.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 14 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.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
All patients 18 years old and older with RA, RARS and RAEB who have a 5q deletion as their sole cytogenetic abnormality who require transfusion support with blood defined as needing at least one unit of packed red blood cells per month for greater than or equal to 2 months and/or thrombocytopenia defined as a platelet count less than 50,000, and/or severe neutropenia (absolute neutrophil count less than 500) are eligible, including patients that had been treated with chemotherapy or experimental agents such as retinoids, phenylbutyrate, amifostine, Vitamin D, ATG or hematopoietic growth factors. Patients must not be transforming to acute leukemia (greater than 20% blasts in marrow aspirate). Patients must not have had treatment with growth factors or any other experimental drug within 4 weeks prior to entry on protocol. Patients must not have an ECOG performance status greater than 2. Patients must not have an active uncontrolled infection. No patients for whom bone marrow transplant is indicated as primary therapy. Must be able to give informed consent. Patients must not be HIV positive. Patients must not be pregnant.
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
Warren G. Magnuson Clinical Center (CC)
Bethesda, United StatesAbrir Warren G. Magnuson Clinical Center (CC) en Google Maps