Hemotrial Un proyecto de SEHH

Ensayo clínico

An Open-Label, Randomized, Multicenter Phase III Trial of Dasatinib (SPRYCEL®) vs.Standard Dose Imatinib (400 mg) in the Treatment of Subjects with Newly DiagnosedChronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia.Ensayo fase III, abierto, aleatorizado, multicéntrico: dasatinib (SPRYCEL) frente a la dosis estándar de imatinib (400 mg) en el tratamiento de pacientes con leucemia mieloide crónica con cromosoma Philadelphia positivo en fase crónica de reciente diagnostico

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Resumen

2016-04-05 20:09:47
2006-005712-27
CA180056
An Open-Label, Randomized, Multicenter Phase III Trial of Dasatinib (SPRYCEL®) vs.Standard Dose Imatinib (400 mg) in the Treatment of Subjects with Newly DiagnosedChronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia.Ensayo fase III, abierto, aleatorizado, multicéntrico: dasatinib (SPRYCEL) frente a la dosis estándar de imatinib (400 mg) en el tratamiento de pacientes con leucemia mieloide crónica con cromosoma Philadelphia positivo en fase crónica de reciente diagnostico
CA180056

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País

Fármacos

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

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

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 Note: this IMP is commercialized in EU u
Novartis
Tablet
Oral use

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 Note: this IMP is commercialized in EU un
Novartis
Tablet
Oral use

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

Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid LeukemiaLeucemia mieloide crónica con cromosoma Philadelphia positivo en fase crónica de reciente diagnostico

To compare the best confirmed complete cytogenetic response (CCyR) rates within 12 months in newly diagnosed chronic phase CML subjects treated with dasatinib 100 mg QD versus imatinib 400 mg QD.

• To compare the following efficacy parameters within 12 months:major molecular response rate (MMR); major cytogenetic response rate (MCyR);complete hematologic response (CHR).• To compare the following study parameters at any time:Best overall MMR, CCyR, MCyR and CHR rate; Durations of and times to MMR, CCyR, MCyR and CHR; Progression-free survival (PFS) and overall survival (OS); Time to treatment failure (TTF).• To evaluate the toxicity profile for each treatment arm.• To explore the development of BCR-ABL point mutations in both treatment arms.

No


1) Subjects able to provide written informed consent.2) Patients must have Ph+ CML in CP which is defined by the presence of all of thefollowing criteria:< 15% blasts in peripheral blood and bone marrow.< 30% blasts plus promyelocytes in peripheral blood and bone marrow.< 20% basophils in the peripheral blood.? 100 x 10E9/L platelets.No evidence of extramedullary leukemic involvement, with the exception ofhepatosplenomegaly. Ph+ or variants must be demonstrated by BM cytogenetics.3) Previously untreated chronic CML [less than 4 weeks (28 days) of imatinib areallowed provided the subject did not experience grade 3-4 hematologic or nonhematologic toxicity attributed to imatinib]4) Subjects must be enrolled in this study within approximately 3 months (90 days) after the date of first being diagnosed with CML, based on cytogenetic test results of bone marrow, demonstrating the presence of the Philadelphia chromosome or variants of the (9;22) translocation. Subjects are allowed to have secondary chromosomal abnormalities (i.e., clonal evolution) in addition to the Philadelphia chromosome and remain eligible.5) ECOG Performance Status (PS) Score 0 - 2.6) Adequate hepatic function defined as: total bilirubin ? 2.0 times the institutionalULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST)? 2.5 times the institutional upper limit of normal (ULN).7) Adequate renal function defined as serum creatinine ? 3 times the institutional ULN.8) Men and women, ages 18 years and older.9) 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 1 month (4 weeks) after the last dose ofinvestigational product in such a manner that the risk of pregnancy is minimized.10) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity25 IU/L or equivalent units of HCG) within 72 hours prior to the start of investigational product.

1) 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) before and for at least 1 month (4 weeks) after the last dose of study medication.2) WOCBP using a prohibited contraceptive method (Not applicable for this study).3) Women who are pregnant or breastfeeding.4) Women with a positive pregnancy test at enrollment or prior to administration ofstudy medication.5) Men whose sexual partners are WOCBP, who are unwilling or unable to use anacceptable method to avoid pregnancy for the entire study period and for at least one month (4 weeks) after completion of study medication.6) A serious uncontrolled medical disorder or active infection that would impair theability of the subject to receive protocol therapy.7) Known pleural effusion at baseline.8) Uncontrolled or significant cardiovascular disease, including any of the following:A myocardial infarction within 6 months; Uncontrolled angina within 3 months; Congestive heart failure within 3 months; Diagnosed or suspected congenital long QT syndrome; Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointe); Prolonged QTcF interval > 450 msec on pre-entry ECG9) History of significant bleeding disorder unrelated to CML, including:Diagnosed congenital bleeding disorders (e.g., von Willebrand’s disease);Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factorVIII antibodies).10) Prior chemotherapy for peripheral stem cell mobilization. (Prior collection ofunmobilized peripheral blood stem cells is permitted).11) Prior or concurrent malignancy, except for the following:adequately treated basal cell or squamous cell skin cancer; cervical carcinoma in situ;adequately treated Stage I or II cancer from which the subject is currently incomplete remission; or any other cancer from which the subject has been disease-free for three years.12) Evidence of digestive dysfunction that would prevent administration of study therapy by mouth.13) Any prior treatment with interferon14) Any prior treatment with dasatinib15) Any other prior systemic treatments, with anti-CML activity [except for anagrelide,hydroxyurea (HU) or 4 weeks (28 days) of imatinib].16) Subjects currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes. Subjects who have discontinued any of these medications must have a wash-out period of at least 5 days or at least 5 half-lives of the drug (whichever is greater) prior to the first dose of study therapy. Amiodarone must be discontinued for at least 14 days prior to randomization.17) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.

The primary efficacy endpoint is the rate of best confirmed CCyR within 12 months.CCyR will be assessed via cytogenetic analysis of bone marrow biopsy/aspirate specimens. Cytogenetic analysis will occur at the local institutions and be reported via CRF.Toxic effects will be assessed continuously and reported for all treated subjects. Adverse events and other symptoms will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

  DISEÑO DEL ENSAYO:

Si
Si

Si
No

No
Si

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

Si
No

No
No

Si

Centros participantes:

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

7
0
  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:

20

Para estudios internacionales:

272
518

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


 EC Finalizado



EC Finalizado