Hemotrial Un proyecto de SEHH

Ensayo clínico

A Phase II Study of MK-0457 in Patients With BCR-ABL T315I Mutant Chronic Myelogenous Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic LeukemiaEstudio en fase II de MK 0457 en pacientes con leucemia mieloide crónica con la mutación T3151 en BCR ABL y leucemia linfoblástica aguda con cromosoma Filadelfia positivo.

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Resumen

2017-03-15 04:01:35
2006-004535-30
MK-0457
A Phase II Study of MK-0457 in Patients With BCR-ABL T315I Mutant Chronic Myelogenous Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic LeukemiaEstudio en fase II de MK 0457 en pacientes con leucemia mieloide crónica con la mutación T3151 en BCR ABL y leucemia linfoblástica aguda con cromosoma Filadelfia positivo.
MK-0457

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Merck Sharp & Dohme de España, S.A. Spain

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test
MK-0457
MK-0457 Intravenous infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:
mg milligram(s) equal

40

Contenido del fármaco

Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General

Síndrome Mielodisplásico, Leucemia Aguda

CML and Ph+ALL

(1). To evaluate the efficacy of MK-0457, as defined by major cytogenetic response in chronic phase CML and as major hematological response in accelerated phase CML, blastic phase CML, and Ph+-ALL, when given as a 5-day CIV infusion every 14 days. (2) To evaluate the safety of MK-0457 with this dose and regimen.

(1). To evaluate the durability of responses with MK-0457. (2). To assess the time to initial hematological response and best hematological response after treatment with MK-0457. (3) To measure the overall hematological response rate in advanced T315I mutant leukemias (i.e. accelerated phase CML, blastic phase CML, and Ph+-ALL), and complete hematological response rate in T315I mutant chronic phase CML. (4). To measure the cytogenetic response rates after treatment with MK-0457.

No


Patient is male or female, and ?18 years of age on day of signing informed consent; ECOG performance status as stated in the protocol; The interval from prior treatment (standard or investigational) to time of study drug administration should be at least 2 weeks for cytotoxic agents or at least 5 half-lives for non-cytotoxic agents. The only exception is hydroxyurea which can be used to control peripheral leukemic cell counts prior to initiating study drug and during the first treatment cycle. Persistent clinically significant chronic toxicities from prior chemotherapy must not be greater than Grade 2 (except alopecia); Patient must have proper organ function as outlined in the protocol; Patients under consideration for inclusion into this study must have Ph+ (or BCR-ABL+) CML or ALL and meet one of the following disease inclusion criteria; Patients with documented BCR-ABL T315I mutation;

Patient has not fully recovered from acute side effects of prior anti-leukemic therapy to ? Grade 2 toxicity, except alopecia; Patient within 3 months of allogeneic bone marrow transplant and/or has active and uncontrolled Graft-versus-Host disease following allogeneic bone marrow transplant and/or not on a stable dose of immunosuppressants for at least one month; Patient has uncontrolled symptomatic congestive heart failure, angina, or had a myocardial infarction in the preceding 3 months; Patient has known hypersensitivity to the components of study drug or its analogs; Patient has uncontrolled active infection; Patient has a known psychiatric or substance abuse disorder that in the opinion of the Investigator would interfere with cooperation with the requirements of the trial; Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the study; Patient has any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study; Patients with “currently active” second malignancy, other than non-melanoma skin cancer, should not be enrolled. Patients are not considered to have a “currently active” malignancy if they have completed therapy for a prior malignancy and are considered by their treating physician to be at less than 30% risk of relapse; Patient is known to be HIV seropositive or who has an AIDS-related illness; Patient has known active hepatitis B or C (and/or treated previously with abnormal liver function tests); Patient has adequate cardiac function by multigated radionucleotide angiography (MUGA) or echocardiography.

The primary endpoints of this protocol is major cytogenetic response (MCyR) for chronic phase CML patients and major hematological response (MHR) for accelerated phase CML, blastic phase CML, and Ph+-ALL patients.

Fase II
  DISEÑO DEL ENSAYO:

No
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT
  COMPARADOR DEL ENSAYO CONTROLADO:

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT

Centros participantes:

Information no disponible en EudraCT
Information no disponible en EudraCT
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO:


28
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO EN ESPAÑA:


  POBLACIÓN DE PACIENTES EN EL ESTUDIO:
  Población de pacientes: 1

Rango de edad:

0
1

1

Sexo:

1
1

Número planeado de pacientes a incluir:

8

Para estudios internacionales:


272

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


 Por Determinar



En Marcha