2-CDA and Rituximab as Remission Induction and Rituximab as In Vivo Purging Prior to Peripheral Stem Cell Mobilization in Patients With Chronic Lymphocytic Leukemia (CLL) - A Prospective Multicenter Phase II Trial
Colección de datos
Enfermedad Crónica+10
+ Enfermedades Hematológicas
+ Enfermedades del sistema inmunitario
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de junio de 2002
Fecha en la que se inscribió al primer participante.OBJECTIVES: Primary * Determine the efficacy and tolerability of cladribine and rituximab as remission induction therapy in patients with chronic lymphocytic leukemia. * Determine the complete remission rate in patients treated with this regimen. Secondary * Determine the very good partial remission rate and nodular partial remission rate in patients treated with this regimen. * Determine the toxicity of this regimen, in terms of hemotoxicity and infection rate, in these patients. * Determine the efficacy of in vivo purging with rituximab measured by immunophenotyping in these patients. * Determine the feasibility of stem cell harvest in these patients after treatment with this induction therapy regimen and in vivo purging with rituximab. OUTLINE: This is a multicenter study. * Remission induction: Patients receive cladribine subcutaneously (SC) on days 1-5. During courses 2-4, patients also receive rituximab IV on day 1. Treatment repeats every 28 days for up to 4 courses in the absence of unacceptable toxicity. If unacceptable toxicity persists, patients receive rituximab alone. Patients not achieving a complete remission (CR), very good partial remission (VGPR), or nodular partial remission (NPR) receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 21 days for up to 4 courses or until patients achieve a CR, VGPR, or NPR. Patients achieving a CR, VGPR, or NPR proceed to stem cell mobilization and in vivo purging. * Stem cell mobilization and in vivo purging: Beginning 8-10 weeks after the first day of the last course of remission induction or CHOP, patients receive rituximab IV on days 1 and 8, cyclophosphamide IV over 4 hours on day 2, and filgrastim (G-CSF) SC daily beginning on day 4 and continuing until the last day of apheresis. Patients undergo apheresis on days 11-14. PROJECTED ACCRUAL: A total of 17-41 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 43 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 18 a 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: * Diagnosis of B-cell chronic lymphocytic leukemia (CLL) * CD5 positive and CD23 positive * Binet stage B, C, or progressive A * Newly diagnosed disease OR no more than 1 prior alkylating agent regimen (e.g., chlorambucil or cyclophosphamide with or without prednisone) PATIENT CHARACTERISTICS: Age * 18 to 65 Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * No autoimmune hemolytic anemia * No immune thrombocytopenia Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2.5 times ULN\* * AST and ALT no greater than 2.5 times ULN\* NOTE: \*Unless clearly related to CLL liver involvement Renal * Creatinine clearance greater than 50 mL/min Cardiovascular * Ejection fraction at least 50% * No severe heart failure * No unstable angina pectoris * No significant arrhythmia requiring chronic treatment * No myocardial infarction within the past 3 months Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 12 months after study participation * HIV negative * No active infection * No positive Coombs' test * No history of significant neurologic or psychiatric disorders, including psychotic disorders or dementia * No seizure disorder * No other malignancy within the past 5 years except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix * No prior allergic reaction or hypersensitivity to study drugs or attributed to compounds of similar chemical or biological composition to study drugs or other study agents * No uncontrolled diabetes mellitus * No gastric ulcers * No active autoimmune disease * No alcohol or drug abuse * No other concurrent serious underlying medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * No prior purine analogs (e.g., cladribine or fludarabine) Endocrine therapy * Not specified Radiotherapy * No concurrent radiotherapy Surgery * Not specified Other * More than 30 days since prior clinical trial participation * No other concurrent experimental drugs
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.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 11 ubicaciones
Oncology Institute of Southern Switzerland
Bellinzona, SwitzerlandInselspital Bern
Bern, SwitzerlandSpitaeler Chur AG
Chur, Switzerland