Phase II Trial Of BL22 Immunotoxin In Hairy Cell Leukemia
BL22
Enfermedades Hematológicas+6
+ Enfermedades del sistema inmunitario
+ Trastornos Inmunoproliferativos
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de octubre de 2003
Fecha en la que se inscribió al primer participante.OBJECTIVES: Primary * Determine the response rate in patients with cladribine-resistant hairy cell leukemia treated with BL22 immunotoxin. Secondary * Determine the response duration in patients treated with this drug. * Determine the safety of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. * Correlate BL22 blood levels and toxicity of this drug with the development of neutralizing antibodies in these patients. OUTLINE: Patients receive BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5 followed by rest. Patients are then evaluated at 8 weeks. Patients achieving complete hematologic remission are followed. All other patients continue to receive BL22 immunotoxin as above on days 1, 3, and 5. Treatment repeats every 4 weeks for up to a total of 16 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR without minimal residual disease (MRD) receive 2 courses beyond CR. Patients achieving CR with MRD receive 4 courses beyond CR. Patients are followed every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 3 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 36 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.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
Criterios
DISEASE CHARACTERISTICS: * Histologically confirmed hairy cell leukemia * CD22-positive disease by fluorescence-activated cell sorting with anti-CD22 antibody * Meets at least 1 of the following indications for treatment: * Absolute neutrophil count less than 1,000/mm\^3 * Hemoglobin less than 10 g/dL * Platelet count less than 100,000/mm\^3 * Absolute lymphocyte count greater than 20,000/mm\^3 * Symptomatic splenomegaly * Meets 1 of the following response criteria: * No response * Complete response (CR) or partial response (PR) less than 2 years in duration after the last course of prior cladribine * CR or PR less than 4 years in duration after a second or later course of prior cladribine PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * AST and ALT no greater than 2.5 times upper limit of normal (ULN) * Bilirubin no greater than 2.2 mg/dL * Albumin at least 3.0 g/dL Renal * Creatinine no greater than 1.4 mg/dL OR * Creatinine clearance at least 50 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No serum that neutralizes more than 75% of the activity of 1 µg/mL of BL22 immunotoxin using a bioassay * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No other concurrent uncontrolled illness that would preclude study participation * Understand and give informed consent PRIOR CONCURRENT THERAPY: Biologic therapy * No prior BL22 immunotoxin * More than 12 weeks since prior monoclonal antibody therapy Chemotherapy * See Disease Characteristics * More than 4 weeks since prior systemic cytotoxic chemotherapy Endocrine therapy * More than 4 weeks since prior systemic steroids (except stable doses of prednisone no greater than 20 mg/day) Radiotherapy * Not specified Surgery * Not specified Other * No other concurrent investigational agents
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos 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
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, United StatesVer ubicación