A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II)
17 de marzo de 2014 actualizado por: Genzyme, a Sanofi Company
A Phase II Study of Single Agent Clofarabine in Previously Untreated Older Adult Patients With Acute Myelogenous Leukemia (AML) for Whom Standard Induction Chemotherapy is Unlikely to be of Benefit
Clolar (clofarabine injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.
This study will evaluate the efficacy of clofarabine in elderly patients with acute myelogenous leukemia (AML) who are unlikely to benefit from treatment with intensive chemotherapy regimens (cytarabine and anthracycline based regimens) used in younger patients with AML.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
116
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Arizona
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Phoenix, Arizona, Estados Unidos
- Mayo Clinical Hospital
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Tucson, Arizona, Estados Unidos
- Arizona Cancer Center
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California
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Los Angeles, California, Estados Unidos
- USC/Norris Comprehensive Cancer Center and Hospital
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San Diego, California, Estados Unidos
- Scripps Cancer Center
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Colorado
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Denver, Colorado, Estados Unidos
- Rocky Mountain Cancer Centers
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Connecticut
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Southington, Connecticut, Estados Unidos
- Cancer Center of Central Connecticut
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Georgia
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Atlanta, Georgia, Estados Unidos
- Emory University School of Medicine
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Augusta, Georgia, Estados Unidos
- Medical College of Georgia
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Illinois
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Chicago, Illinois, Estados Unidos
- Rush University Medical Center
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Massachusetts
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Boston, Massachusetts, Estados Unidos
- Beth Israel Deaconess Medical Center
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Michigan
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Ann Arbor, Michigan, Estados Unidos
- University of Michigan Comprehensive Cancer Center
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New York
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New York, New York, Estados Unidos
- Mount Sinai School of Medicine
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Oregon
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Portland, Oregon, Estados Unidos
- Oregon Health and Science University
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Pennsylvania
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Hershey, Pennsylvania, Estados Unidos
- Penn State Hershey Medical Center
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Tennessee
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Nashville, Tennessee, Estados Unidos
- Vanderbilt University Medical Center
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Texas
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Houston, Texas, Estados Unidos
- University of MD Anderson Cancer Center
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San Antonio, Texas, Estados Unidos
- Cancer Care Centers of South Texas
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Utah
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Salt Lake City, Utah, Estados Unidos
- University of Utah - Huntsman Cancer Institute
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Washington
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Seattle, Washington, Estados Unidos
- Seattle Cancer Care Alliance
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West Virginia
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Morgantown, West Virginia, Estados Unidos
- West Virginia University - HSC
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
60 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Diagnosis of AML (de novo, secondary or with an antecedent hematologic disorder [AHD])
- Age ≥ 60 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Presence of at least one adverse prognostic factor: Age ≥ 70 years; or AHD; or ECOG performance status of 2; or Intermediate or unfavorable (i.e., adverse) karyotype defined as any cytogenetic profile except the presence of any of the following:
- t(8;21)(q22;q22)
- inv(16)(p13;q22 or t(16;16)(p13;q22)
- t(15;17)(q22;q12) and variants.
- Adequate renal and hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN; and Serum creatinine ≤ 1.0 mg/dL; if serum creatinine > 1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be > 60 mL/min/1.73 m^2 as calculated by the Modification of Diet in Renal Disease (MDRD) equation
- Adequate cardiac function: left ventricular ejection fraction (LVEF) ≥ 40% or left ventricular fractional shortening ≥ 22%
Exclusion Criteria:
- Diagnosis of acute promyelocytic leukemia
- Prior treatment with clofarabine
- Prior treatment for AML or an antecedent hematologic disorder
- Prior hematopoietic stem cell transplant (HSCT)
- Prior radiation therapy to the pelvis
- Investigational agent received within 30 days prior to the first dose of study drug
- Ongoing uncontrolled systemic infection
- Diagnosis of another malignancy, unless the patient has been disease-free for at least 5 years following the completion of curative intent therapy with the following exceptions: Patients with treated non-melanoma skin cancer, in-situ carcinoma or cervical intraepithelial neoplasia regardless of disease-free duration are eligible for this study if definitive treatment for the condition has been completed; Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on PSA value are eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed
- Clinical evidence of central nervous system (CNS) involvement
- Severe concurrent medical condition or psychiatric disorder that would preclude study participation
- Positive human immunodeficiency virus (HIV) test
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Clofarabine
Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days.
Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
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Induction cycle 1: cycle 1 of clofarabine 30 mg/m^2/day as a 1-hour intravenous infusion for 5 consecutive days. Reinduction (cycle 2) and/or Consolidation cycles (cycles 2-6): cycles repeated minimally every 28 days, of clofarabine 20 mg/m^2/day as a 1-hour intravenous infusion for 5 consecutive days.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Participants Achieving Overall Remission (OR) After No More Than Two Cycles (Approximately Month 2)
Periodo de tiempo: approximately Month 2
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Best response was assessed by the Independent Response Review Panel(IRRP) after two cycles of treatment.
Overall remission(OR) is the sum of complete remission(CR) and complete remission in the absence of platelet recovery(CRp).
CR includes normal values for peripheral blood cell counts (absolute neutrophil and platelet) and leukemic blast cells from bone marrow biopsy or aspirate, and absence of extramedullary disease.
Partial remission(PR) includes recovery of peripheral blood cells with improved but still abnormal values in leukemic blast cells.
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approximately Month 2
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Kaplan Meier Estimate for Duration of Remission (DOR)
Periodo de tiempo: Up to 2 years
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DOR was defined as the number of days from achievement of OR as assessed by the Independent Response Review Panel (IRRP) until IRRP-determined disease recurrence or death (any cause), plus 1 day.
Participants who initiated alternative antileukemic treatment while in remission were censored on the date the therapy was initiated or on the date of last follow-up.
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Up to 2 years
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Kaplan Meier Estimate for Disease-free Survival (DFS)
Periodo de tiempo: Up to 2 years
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DFS was defined as the number of days from achievement of IRRP-determined overall response until IRRP-determined disease recurrence or death (any cause), regardless of intervening alternative antileukemic treatment, plus 1 day.
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Up to 2 years
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Kaplan Meier Estimates for Overall Survival (OS)
Periodo de tiempo: Up to 2 years
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OS was defined as the number of days from first dose of clofarabine until death for all participants, plus 1 day.
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Up to 2 years
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Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment and Follow-up Periods
Periodo de tiempo: Up to 2 years
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Participants with AEs that occurred during the treatment and follow-up periods. AEs were classified according to severity (graded using National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) and relationship to study drug. Treatment emergent is defined as any event that either first presents after baseline or worsens in severity after baseline. NCI Common Terminology Criteria for Severity: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5= Death related to AE |
Up to 2 years
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Percentage of Participants Who Died Within Thirty Days of Treatment (30-day Mortality Rate)
Periodo de tiempo: up to Day 30
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Percentage of participants who died within 30 days of the first dose of study drug, regardless of cause.
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up to Day 30
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants Achieving Overall Remission After A Maximum of Two Cycles by Subgroup of Baseline Prognostic Factors
Periodo de tiempo: approximately Month 2
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The number of participants within each subgroup of baseline prognostic factors of the full analysis set who achieved a best response of either a complete response (CR) or a complete response in the absence of platelet recovery (CRp) as determined by the Independent Response Review Panel following a maximum of two cycles of treatment.
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approximately Month 2
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 2006
Finalización primaria (Actual)
1 de mayo de 2008
Finalización del estudio (Actual)
1 de mayo de 2010
Fechas de registro del estudio
Enviado por primera vez
7 de septiembre de 2006
Primero enviado que cumplió con los criterios de control de calidad
7 de septiembre de 2006
Publicado por primera vez (Estimar)
8 de septiembre de 2006
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
14 de abril de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
17 de marzo de 2014
Última verificación
1 de marzo de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CLO24300606
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .