Hemotrial Un proyecto de SEHH

Ensayo clínico

Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome PositiveAcute Lymphoblastic Leukemic Subjects Who are Experiencing Clinical Benefit onCurrent START Protocols: Long Term Safety and Efficacy Analysis."Dasatinib en pacientes con Leucemia Mieloide Crónica o con Leucemia Linfoblástica Aguda Cromosoma Filadelfia positivo que han obtenido Beneficio Clínico en los protocolos del programa START: Análisis a largo plazo de eficacia y seguridad."

  • Guardar


Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome PositiveAcute Lymphoblastic Leukemic Subjects Who are Experiencing Clinical Benefit onCurrent START Protocols: Long Term Safety and Efficacy Analysis."Dasatinib en pacientes con Leucemia Mieloide Crónica o con Leucemia Linfoblástica Aguda Cromosoma Filadelfia positivo que han obtenido Beneficio Clínico en los protocolos del programa START: Análisis a largo plazo de eficacia y seguridad."


Resumen

2017-03-15 04:05:39
2007-003624-37
CA180-188
Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome PositiveAcute Lymphoblastic Leukemic Subjects Who are Experiencing Clinical Benefit onCurrent START Protocols: Long Term Safety and Efficacy Analysis."Dasatinib en pacientes con Leucemia Mieloide Crónica o con Leucemia Linfoblástica Aguda Cromosoma Filadelfia positivo que han obtenido Beneficio Clínico en los protocolos del programa START: Análisis a largo plazo de eficacia y seguridad."
CA180-188

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Bristol Myers Squibb International Corporation Belgium

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test Sprycel
Bristol-Myers Squibb Pharma EEIG
Film-coated tablet
Oral use

Detalles del Fármaco (Principio Activo):

BMS-354825-03

Concentración del fármaco:

mg milligram(s) equal

20

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 2:
Test Sprycel
Bristol-Myers Squibb Pharma EEIG
Film-coated tablet
Oral use

Detalles del Fármaco (Principio Activo):

BMS-354825-03

Concentración del fármaco:

mg milligram(s) equal

50

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 3:
Comparator Gleevec
Novartis
Tablet
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

100

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 4:
Comparator Gleevec
Novartis
Tablet
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

400

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



Sindromes Mieloproliferativos

Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects.Pacientes con Leucemia Mieloide Crónica o con Leucemia Linfoblástica Aguda Cromosoma Filadelfia positivo


The primary objective is to determine the long term safety and tolerability of dasatinib.

The secondary objective of this study is to collect long term efficacy in terms ofmolecular response.

No


1) Signed Written Informed Consent2) Target Population (consistent with prior START protocols)a) Treatment on protocols CA180005, CA180006, CA180013, CA180015 orCA180017.b) Receiving clinical benefit with dasatinib or imatinib (study CA180017) in theopinion of the Investigator.3) Age and SexMen and women, ages 18 and older may participate.Women of childbearing potential (WOCBP) must be using an adequate method ofcontraception to avoid pregnancy throughout the study and for a period of at least1 month (4 weeks) before and at least 3 months (12 weeks) after the last dose ofinvestigational product in such a manner that risk of pregnancy is minimized.

1) Sex and Reproductive Statusa) WOCBP who are unwilling or unable to use an acceptable method to avoidpregnancy for the entire study period and for at least one month (4 weeks) beforeand for at least 3 months (12 weeks) after the last dose of study medication.b) WOCBP using a prohibited contraceptive method (Not applicable for this study).c) Women who are pregnant or breastfeedingd) Women with a positive pregnancy test on enrollment or prior to investigationalproduct administration.e) Sexually active fertile men whose sexual partner(s) are WOCBP, who areunwilling or unable to use an effective method to avoid pregnancy for the entirestudy period and for at least 3 months (12 weeks) after completion of studymedication.2) Medical History and Concurrent Diseasesa) A serious uncontrolled medical disorder or active infection that would impair theability of the subject to receive protocol therapyb) Dementia or altered mental status that would prohibit the understanding orrendering of informed consent3) Prohibited Treatments and/or Therapiesa) Subjects currently taking drugs that are generally accepted to have a risk ofcausing Torsades de Pointes including, but not limited to:* quinidine, procainamide, disopyramide* amiodarone, sotalol, ibutilide, dofetilide* erythromycins, clarithromycin* chloropromazine, haloperidol, mesoridazine, thioridazine, pimozide, zyprasidone* cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone,halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazineb) Subjects taking medications known to be potent CYP3A4 inhibitors(i.e.ketoconazole, ritonavir) or inducers (i.e., rifampin, efavirenz).4) Other Exclusion Criteriaa) Prisoners or subjects who are involuntarily incarceratedb) Subjects who are compulsorily detained for treatment of either a psychiatric orphysical (eg, infectious disease) illnessEligibility criteria for this study have been carefully considered to ensure the safety of the study subjects and to ensure that the results of the study can be used. It is imperative that subjects fully meet all eligibility criteria.

SafetyIn this study, all SAEs, Grade 5 AEs, AEs previously not reported, AEs leading to discontinuation and nonserious AEs of special interest, which include: fluid retention, cardiac events, skin toxicity, hemorrhage, and myelosuppression will be collected. The exception will be in certain countries where all AEs are required to be collected and reported per local regulations. Adverse events will be graded according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0EfficacyEfficacy analysis will include major molecular response assessments. BCR-ABL transcripts in peripheral blood will be evaluated using real time quantitative polymerase chain reaction (RQ-PCR). Cytogenetic assessments are not required and will be performed at the Investigators' discretion - cytogenetic data will not be collected.

Fase II
  DISEÑO DEL ENSAYO:

Si
No

Si
No

No
Si

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

Si
No

No
Si

No

Centros participantes:


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

3
1
  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:


2

Para estudios internacionales:


135
313

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


Por Determinar



En Marcha