Clofarabine and Daunorubicin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
7 de julio de 2016 actualizado por: Roswell Park Cancer Institute
A Phase II Study Evaluating Mechanisms of Resistance Following Treatment With Clofarabine and Daunorubicin in Newly Diagnosed Adult Acute Myeloid Leukemia Patients > or = to 60 Years Old
RATIONALE: Drugs used in chemotherapy, such as clofarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving clofarabine together with daunorubicin may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving clofarabine together with daunorubicin works in treating older patients with newly diagnosed acute myeloid leukemia.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
OBJECTIVES:
Primary
- Study complete response (CR) and CR without platelet recovery (CRp) following treatment with clofarabine and daunorubicin hydrochloride in older patients with newly diagnosed acute myeloid leukemia.
Secondary
- Study disease-free and overall survival of these patients following treatment with this regimen.
- Compare disease-free and overall survival of patients whose cells do or do not demonstrate apoptosis following treatment with this regimen.
OUTLINE:
- Induction therapy: Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5. Patients are assessed after induction course 1. Patients with ≥ 5% blasts in bone marrow may receive another course of induction therapy beginning between 28-84 days after initiation of course 1. Patients who achieve complete remission (CR) or CR without platelet recovery (CRp) (after 1 or 2 courses of induction therapy) proceed to consolidation therapy.
- Consolidation therapy: Beginning between 28 -84 days after initiation of last course of induction therapy, patients receive clofarabine IV over 1 hour on days 1-3 and daunorubicin hydrochloride IV over 5 minutes on days 1 and 3. Patients may receive a second course of consolidation therapy beginning between 28-84 days of consolidation course 1.
Blood and bone marrow samples are collected periodically to assess response and for pharmacokinetic, cytogenetic, immunophenotyping, and molecular analyses.
After completion of study treatment, patients are followed for at least 2 years.
Tipo de estudio
Intervencionista
Inscripción (Actual)
21
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
-
-
New York
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Buffalo, New York, Estados Unidos, 14263-0001
- Roswell Park Cancer Institute
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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 a 120 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
DISEASE CHARACTERISTICS:
Newly diagnosed acute myeloid leukemia
- At least 10% blasts in the peripheral blood
- De novo or secondary disease
- No acute promyelocytic leukemia with t[15;17] or any other variant
- No clinical evidence of CNS disease
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- LVEF ≥ 45%
- Estimated glomerular filtration rate ≥ 50 mL/min
- Not pregnant or nursing
- Fertile patients must use effective barrier contraception during and for at least 6 months following study treatment
- No known HIV positivity
- Able to comply with study procedures and follow-up examinations
- No psychiatric disorders that would interfere with consent, study participation, or follow-up
- No uncontrolled systemic fungal, bacterial, viral, or other infection (i.e., exhibiting ongoing signs/symptoms related to the infection and without improvement despite appropriate antibiotics or other treatment)
- No history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo induction therapy with both agents
No other malignancy, unless disease-free for at least 3 years following curative intent therapy
- Nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are allowed 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 prostate-specific antigen values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed
- No other severe concurrent disease
PRIOR CONCURRENT THERAPY:
- No other concurrent systemic antileukemic therapy (standard or investigational)
- No concurrent cytotoxic therapy or investigational therapy
- No concurrent alternative medications (e.g., herbal or botanical for anticancer purposes)
No prior chemotherapy
- Prior hydroxyurea allowed
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 |
|---|---|
|
Experimental: Clorafarbine with daunorubicin
Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.
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Estudio Correlativo
Estudio Correlativo
IV
IV
Correlative study
Correlative Study
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Complete Remission (CR)
Periodo de tiempo: 2 years
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Complete Response/Remission (CR) was defined on morphologic criteria at a single response assessment as follows: A bone marrow aspirate or biopsy of < 5% blasts, with evidence of normal hematopoiesis; Absence of Auer rods in the blast that are present; Absence of extramedullary disease [imaging required only if obtained pretreatment for known site(s) of disease]; If applicable and available, absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotyping; Recovery of peripheral counts (platelets ≥100x109/L, and ANC ≥1.0x109/L).
Peripheral count recovery must be documented no earlier than 7 days prior to, and no later than 14 days following, the bone marrow assessment that provides evidence of the CR.
Complete Response/Remission without platelet recovery (CRp) was defined as all criteria for CR except for thrombocytopenia (platelet count ≥75x109/L).
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2 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Disease-free Survival
Periodo de tiempo: 5 years
|
Disease-free survival was defined as time from first objective documentation of CR or CRp until the date of first objective documentation of disease relapse or death due to any cause, whichever occurs first.
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5 years
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Overall Survival
Periodo de tiempo: 4 years
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Overall survival was defined as time from date of treatment initiation until date of death due to any cause.
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4 years
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Differences in Disease-free and Overall Survival Between Patients Whose Cells do or do Not Demonstrate Apoptosis Following Clofarabine and Daunorubicin Hydrochloride Therapy
Periodo de tiempo: 4 years
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4 years
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Difference in Disease-free and Overall Survival According to p53R2 Protein Sizes
Periodo de tiempo: 4 years
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4 years
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Difference in Disease-free and Overall Survival According to Multi-drug Resistance Protein Expression
Periodo de tiempo: 4 years
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4 years
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Difference in Disease-free and Overall Survival Based on Clofarabine Triphosphate Levels
Periodo de tiempo: 4 years
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4 years
|
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A Preliminary Relationship Between Treatment Outcome and Biologic Parameters
Periodo de tiempo: 4 years
|
4 years
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Meir Wetzler, MD, Roswell Park Cancer Institute
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 diciembre de 2008
Finalización primaria (Actual)
1 de junio de 2013
Finalización del estudio (Actual)
1 de agosto de 2013
Fechas de registro del estudio
Enviado por primera vez
23 de diciembre de 2008
Primero enviado que cumplió con los criterios de control de calidad
23 de diciembre de 2008
Publicado por primera vez (Estimar)
24 de diciembre de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
17 de agosto de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
7 de julio de 2016
Última verificación
1 de julio de 2016
Más información
Términos relacionados con este estudio
Palabras clave
- leucemia mieloide aguda en adultos con anomalías 11q23 (MLL)
- leucemia mieloide aguda en adultos con inv(16)(p13;q22)
- leucemia mieloide aguda en adultos con t(16;16)(p13;q22)
- leucemia mieloide aguda en adultos con t(8;21)(q22;q22)
- leucemia mieloide aguda secundaria
- leucemia mieloide aguda en adultos no tratada
- leucemia megacarioblástica aguda del adulto (M7)
- adulto leucemia mieloide mínimamente diferenciada aguda (M0)
- leucemia monoblástica aguda del adulto (M5a)
- leucemia monocítica aguda del adulto (M5b)
- leucemia mieloblástica aguda del adulto con maduración (M2)
- leucemia mieloblástica aguda del adulto sin maduración (M1)
- leucemia mielomonocítica aguda del adulto (M4)
- eritroleucemia del adulto (M6a)
- leucemia eritroide pura del adulto (M6b)
Términos MeSH relevantes adicionales
- Neoplasias por tipo histológico
- Neoplasias
- Leucemia
- Leucemia Mieloide
- Leucemia Mieloide Aguda
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Antibióticos, Antineoplásicos
- Clofarabina
- Daunorrubicina
Otros números de identificación del estudio
- CDR0000630678
- RPCI-I-132208 (Otro identificador: Roswell Park Cancer Institute)
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. .