Hemotrial Un proyecto de SEHH

Ensayo clínico

Estudio abierto y aleatorizado en fase 3 de L-malato de amonafida en combinación con citarabina comparado con daunorrubicina en combinación con citarabina en pacientes con leucemia mieloide aguda (LMA) secundariaPhase 3 Open-Label Randomized Study of Amonafide L-Malate in Combination withCytarabine Compared to Daunorubicin in Combination with Cytarabine in Patients with Secondary Acute Myeloid Leukemia (AML)

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Resumen

2017-03-15 04:06:18
2007-004427-38
0001A3-300-GL
Estudio abierto y aleatorizado en fase 3 de L-malato de amonafida en combinación con citarabina comparado con daunorrubicina en combinación con citarabina en pacientes con leucemia mieloide aguda (LMA) secundariaPhase 3 Open-Label Randomized Study of Amonafide L-Malate in Combination withCytarabine Compared to Daunorubicin in Combination with Cytarabine in Patients with Secondary Acute Myeloid Leukemia (AML)
0001A3-300-GL

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Antisoma Research Ltd. United Kingdom

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test
Amonafide L-malate
Concentrate for solution for infusion
Intravascular use (Noncurrent)

Detalles del Fármaco (Principio Activo):

Amonafide L-mal

Concentración del fármaco:

mg/ml milligram 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 2:
Comparator
cytarabine
Concentrate for solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg/m2 milligram equal

200

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
daunorubicin
Powder for solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg/m2 milligram equal

45

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



Leucemia Aguda

leucemia mieloide aguda sencudaria(secondary acute myeloid leukemia)


The rate of confirmed complete remission with or without hematopoietic recovery [complete remission (CR) and complete remission with incomplete hematopoietic recovery (CRi); this includes complete cytogenetic remission (CRc) and complete remission with persistent morphologic dysplasia (CRd)]. Confirmed CR or CRi is defined as documentation of CR or CRi at least 30 days after initial determination of CR or CRi following remission induction therapy, or immediately prior to postremission therapy if such therapy occurs within 30 days from the initial determination of CR or CRi.

- Rate of initial complete remission with or without hematopoietic recovery;- Rate of CR + CRi within different clinical subsets;- Rate of response overall and within different clinical subsets;- Rate of response for each individual response category overall and within different clinical subsets;- Median duration of remission; - Median duration of disease free survival (DFS);- Proportion of patients remaining in remission at 6 months, at 12 months, and at 18 months;- Median duration of overall survival (OS) for all patients, for all patients in remission and for each individual response category;- Correlation of clinical responses, duration of responses, DFS and OS with cytogenetic abnormalities;- Correlation of clinical responses, duration of responses, DFS and OS with expression and function of Pgp;- Correlation of PK exposure of amonafide and N-acetyl amonafide with both safetyand efficacy assessments.

No


a.) Diagnosis of AML according to WHO diagnostic criteria (at least 20% blasts in the peripheral blood or bone marrow), with FAB classification other than M3 (AcutePromyelocytic Leukemia), documented by bone marrow aspiration and biopsyperformed within 14 days prior to administration of 1st dose of remission inductionchemotherapy;b.) Eithera. Known and documented exposure to specific leukemogenic therapy of a specified nature for a non-myeloid condition. ORb. Documented diagnosis of MDS or chronic myelomonocytic leukemia (CMML) according to WHO criteria for at least 3 months prior to study entry, with prior bone marrow aspirate, biopsy and peripheral blood smear documenting MDS available to be submitted for subsequent central pathology review.c.) Age 18 years or older;d.) Eastern Cooperative Oncology Group (ECOG) performance score ? 2;e.) Fertile sexually active patients (men and women) must use an effective method ofcontraception which must be continued throughout the study.f.) Women of childbearing potential must have a negative serum pregnancy test. Awoman of childbearing potential is defined as one who is biologically capable ofbecoming pregnant. This includes women who are using contraceptives or whosesexual partners are either sterile or using contraceptives;g.) Left Ventricular Ejection Fraction (LVEF) ? 50%, as determined by multiple-gatedacquisition scan (MUGA) or echocardiogram (ECHO) within 14 days prior toadministration of 1st dose of remission induction chemotherapy;h.) Adequate renal function as evidenced by the following laboratory test, obtainedwithin 14 days prior to administration of 1st dose of remission inductionchemotherapy:?Serum creatinine ? 1.5 x ULN;i.) Adequate hepatic function as evidenced by the following laboratory tests, obtained within 14 days prior to administration of 1st dose of remission inductionchemotherapy (unless attributed to hepatic involvement with AML):?Total serum bilirubin ? 1.5 x ULN;?Serum AST and ALT ? 1.5 x ULN;j.) Ability of the patient to participate fully in all aspects of this clinical trial;k.) Written Informed Consent and HIPAA authorization (USA sites only) must beobtained and documented.

a.) Histologic diagnosis of FAB M3 Acute Promyelocytic Leukemia;b.) Clinically active CNS leukemia;c.) Prior induction therapy for AML;d.) Known HIV positive;e.) Known active hepatitis B or C, or any other active liver disease;f.) Patients with parenchymal abnormality on screening chest x-ray must have noevidence of pulmonary infection on chest tomography (CT) prior to starting remissioninduction therapy.g.) Any major surgery or radiation therapy within 4 weeks prior to study entry;h.) Prior cytotoxic chemotherapy for MDS within 4 weeks prior to study entry (patients with rapidly rising blast count may be enrolled within 4 weeks of prior cytotoxic chemotherapy with waiver from the Medical Monitor);i.) Persistent chronic non-hematologic toxicity (other than alopecia) greater than grade 1 from prior therapy for MDS;j.) Serious concomitant illnesses (for example, pulmonary infiltrate, unstable angina or myocardial infarction or stroke within 3 months prior to study entry, congestive heart failure AHA class 2 or greater, uncontrolled hypertension, uncontrolled diabetes, actively bleeding gastric ulcer, etc.), which in the investigator?s opinion would not make the patient a good candidate for the trial;k.) Pregnant or breast feeding;l.) History of clinically significant allergic reactions attributed to compounds of similarchemical or biological composition to amonafide, cytarabine or daunorubicin;m.) Prior enrollment in this trial;n.) Any other known condition (e.g., familial, sociological, or geographical) or behavior(including substance dependence or abuse, psychological or psychiatric illness), which in the investigator?s opinion would make the patient a poor candidate for thetrial.

The rate of confirmed CR + CRi (which includes CRc and CRd) will be determined by assessing the proportion of patients who achieved confirmed CR or CRi among all evaluable patients. Peripheral blood hematopoietic recovery in accord with a CR may occur up to several months after resolution of leukemia, i.e., < 5% blasts in the bone marrow.

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

Si
No

No
No

No
Si
  COMPARADOR DEL ENSAYO CONTROLADO:

Si
No

No
No

Si

Centros participantes:


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

3
6
  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:


12

Para estudios internacionales:


225
420

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


EC Finalizado



EC Finalizado