Clinical Trials Register

Summary
EudraCT Number:	2014-000319-15
Sponsor's Protocol Code Number:	FLUGAZA
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-06-09
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2014-000319-15

A.3

Full title of the trial

A phase III, multicentre, randomized, open label clinical trial comparing azacytidine (Vidaza®) versus fludarabine plus cytarabine in elderly patients with newly diagnosed acute myeloid leukemia.

ESTUDIO FASE III, MULTICÉNTRICO, ALEATORIZADO, ABIERTO DE AZACITIDINA (VIDAZA®) FRENTE A FLUDARABINA Y CITARABINA (ESQUEMA FLUGA) EN PACIENTES ANCIANOS CON LEUCEMIA MIELOIDE AGUDA DE NUEVO DIAGNÓSTICO.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Clinical trial comparing azacytidine (Vidaza®) versus fludarabine plus cytarabine in elderly patients with newly diagnosed acute myeloid leukemia

ESTUDIO DE AZACITIDINA (VIDAZA®) FRENTE A FLUDARABINA Y CITARABINA (ESQUEMA FLUGA) EN PACIENTES ANCIANOS CON LEUCEMIA MIELOIDE AGUDA DE NUEVO DIAGNÓSTICO.

A.4.1

Sponsor's protocol code number

FLUGAZA

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Fundación PETHEMA
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Celgene S.L.
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Dynamic
B.5.2	Functional name of contact point	Liana de Plaasencia
B.5.3	Address:
B.5.3.1	Street Address	c/ Azcona, 31
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28028
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034914561105
B.5.5	Fax number	0034914561126
B.5.6	E-mail	l.plasencia@dynasolutions.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Vidaza
D.2.1.1.2	Name of the Marketing Authorisation holder	Celgene Europe Ltd
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	ORPHA134183
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Lyophilisate for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	AZACITIDINE
D.3.9.1	CAS number	320-67-2
D.3.9.4	EV Substance Code	SUB05624MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Beneflur
D.2.1.1.2	Name of the Marketing Authorisation holder	Genzyme Europe B.V.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FLUDARABINE PHOSPHATE
D.3.9.1	CAS number	75607-67-9
D.3.9.4	EV Substance Code	SUB13897MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Fludarabine
D.3.4	Pharmaceutical form	Lyophilisate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FLUDARABINE
D.3.9.1	CAS number	21679-14-1
D.3.9.4	EV Substance Code	SUB07678MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Cytarabine
D.3.4	Pharmaceutical form	Concentrate for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CYTARABINE
D.3.9.3	Other descriptive name	CYTARABINE
D.3.9.4	EV Substance Code	SUB06880MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 5
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Cytarabine
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CYTARABINE
D.3.9.3	Other descriptive name	CYTARABINE
D.3.9.4	EV Substance Code	SUB06880MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Newly diagnosed acute myeloid leukemia.

Leucemia mieloide aguda de nuevo diagnóstico.

E.1.1.1

Medical condition in easily understood language

Acute myeloid leukemia.

Leucemia mieloide aguda.

E.1.1.2

Therapeutic area

Diseases [C] - Blood and lymphatic diseases [C15]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
E.1.2	Level	LLT
E.1.2	Classification code	10000886
E.1.2	Term	Acute myeloid leukemia
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the overall survival (OS) in one year treatment with 2 first-line regimens in newly diagnosed elderly patients: 3 cycles of induction chemotherapy based on fludarabine and cytarabine (FLUGA scheme) followed by maintenance with reduced doses (Mini-FLUGA) (standard treatment arm) versus subcutaneous azacitidine cycles (experimental treatment arm).

Evaluar la supervivencia global (SG) al año con 2 esquemas de primera línea en pacientes ancianos de nuevo diagnóstico: 3 ciclos de inducción con quimioterapia basada en fludarabina y citarabina (esquema FLUGA) seguidos de mantenimiento con dosis reducidas del mismo (Mini-FLUGA) (rama de tratamiento estándar), frente a ciclos de azacitidina subcutánea (rama de tratamiento experimental).

E.2.2

Secondary objectives of the trial

1.- Evaluate and compare between the two treatment arms the event free survival (EFS), disease-free survival and relapse-free survival at 1st, 2nd and 3rd year, and the cumulative incidence of relapse (CIR).
2.- To assess the duration of remission.
3.- Evaluate overall survival at 2nd and 3rd year.
4- Evaluate the impact in the quality of life in both arms (EQ-5D).
5.- Evaluate the impact of health care resources during the treatment phase
6.- Assess the depth of complete remission (CR) by the percentage of minimal residual disease (MRD) in bone marrow measured by flow cytometry.
7.- To assess the overall response rate after 3 cycles of treatment in both arms.
8.- Evaluate early mortality (first 4 and 8 weeks) in both arms.
9.- Compare hematologic and non-hematologic toxicity in both arms.
10.- Predictors of response.

1- Evaluar y comparar entre ambas ramas terapéuticas la supervivencia libre de evento (EFS), libre de enfermedad (DFS) y libre de recaída (RFS) al 1º, 2º y 3º año, así como la incidencia acumulada de recaída (CIR).
2.- Evaluar la duración de la remisión.
3- Evaluar la supervivencia global al 2º y 3º año.
4- Evaluar el impacto en la calidad de vida en pacientes en ambas ramas (formulario EQ-5D).
5- Evaluar el impacto de los recursos sanitarios durante la fase de tratamiento (antibióticos, transfusiones, nº y duración de las hospitalizaciones, días de asistencia en hospital de día).
6- Evaluar la profundidad de la RC según el porcentaje de EMR en médula ósea medida con citometría de flujo.
7- Evaluar la tasa de respuesta global tras 3 ciclos de tratamiento en ambas ramas.
8- Evaluar la mortalidad precoz (primeras 4 y 8 semanas) en los pacientes en ambas ramas.
9- Comparar la toxicidad hematológica y no hematológica en ambas ramas.
10.- Factores pronósticos de respuesta.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1 - Having voluntarily given informed consent before performing any test that is not part of routine care of patients.
2 - Age greater than or equal to 65.
3 - Morphological diagnosis of non-promyelocytic AML according to the WHO criteria.
4 - Newly diagnosed AML.
5 - ECOG performance status <4.
6 - Ability and willingness to comply with the schedule of study visits.

1- Haber otorgado voluntariamente el consentimiento informado antes de la realización de cualquier prueba del ensayo que no forme parte de la atención habitual de los pacientes.
2- Edad mayor o igual a 65 años.
3- Diagnóstico morfológico de LMA no promielocítica de acuerdo a los criterios de la WHO.
4- LMA de nuevo diagnóstico.
5- ECOG performance status <4.
6- Posibilidad y disposición para cumplir el calendario de visitas del estudio.

E.4

Principal exclusion criteria

1 - Genetic diagnosis of acute promyelocytic leukemia.
2 - Patients with AML secondary to myelodysplastic syndrome (MDS) or chronic myeloproloferative syndrome who have been previously treated with antileukemic agents (hypomethylating or standard chemotherapy). Treatment with hydroxyurea prior to randomization is allowed.
3 - Serum creatinine ? 250 mmol / l ( ? 2.5 mg/dL ) (unless attributed to AML) .
4 - Bilirubin , alkaline phosphatase or ALT > 5 times the value of the upper limit of normal (unless attributed to AML) .
5 - Presence of an active and/or non controlled pathology different to AML which is severe and life-threatening, that in the investigator's opinion, prevents the subject participation in the study .
6 - Other active concomitant malignancy or whose remission is less than one year from the screening day (except carninoma in situ).
7 - Presence of any psychiatric illness or medical condition that , in the investigator's opinion, prevents the subject participation in the study .
8 - Life expectancy less than X months.
9 - Inability of the patient or his legal representative to understand and voluntarily sign the informed consent form.

1- Diagnóstico genético de leucemia promielocítica aguda.
2- Pacientes con LMA secundaria a síndrome mielodisplásico (SMD) o síndrome mieloproloferativo crónico (SMPC) que hayan sido tratados previamente con agentes antileucémicos (hipometilantes o quimioterapia estándar) para el SMD o SMPC. El tratamiento con hidroxiurea previo a la aleatorización está permitido.
3- Creatinina sérica ? 250 ?mol/l (? 2,5 mg/dL) (excepto si se atribuye a la actividad de la LMA).
4- Bilirrubina, fosfatasa alcalina o GOT > 5 veces el valor del límite superior de normalidad (excepto si se atribuye a la actividad de la LMA).
5- Presencia de una patología diferente de la LMA severa y amenazante para la vida de forma inmediata activa y/o no controlada que, en opinión del investigador, impida al sujeto participar en el estudio.
6- Otra neoplasia concomitante activa o cuya duración de la remisión sea inferior a un año desde el día del screening (exceptuando carninoma in situ).
7- Presencia de cualquier enfermedad psiquiátrica o trastorno médico que, en opinión del investigador, impida al sujeto participar en el estudio.
8- Esperanza de vida menor de X meses.
9- Incapacidad del paciente o su representante legal para entender y firmar voluntariamente el formulario de consentimiento informado.

E.5 End points

E.5.1

Primary end point(s)

Overall survival one year from the start of the study treatment.

Supervivencia global al año desde el inicio de tratamiento.

E.5.1.1

Timepoint(s) of evaluation of this end point

1 year after tretament start.

1 año

E.5.2

Secondary end point(s)

1. Event-free survival (from the administration of the first dose of treatment) the first, second and third year , defining "event" as relapse or death from any cause.
2. Disease-free survival (from the administration of the first dose of treatment) the first, second and third year.
3. Relapse-free survival for first, second and third year.
4. Duration of remission.
5. Cumulative incidence of relapse.
6. Overall survival at second and third year from the start of treatment.
7. Quality of life of patients assessed by the EQ- 5D questionnaire.
8. Use of antibiotics , transfusions, number and duration of hospitalizations , number of days of attendance at the day hospital.
9. Depth of the RC by the percentage of MRD, performed after three cycles (after the induction phase ) and 9 (after the consolidation phase ) treatment in those patients who achieved CR or CRi .
10. Overall response rate after 3 cycles of treatment in patients initially treated with the experimental therapy ( azacitidine ) compared to patients treated with standard chemotherapy (fludarabine and cytarabine).
11. Early mortality (within 60 days).
12. Haematological and non-haematological toxicity (type, intensity, frequency and severity) according to the Common Terminology Criteria for Adverse Events (CTCAE ) of the National Cancer Institute, version 4.0. Published: May 28 , 2009 (v4.03 : June 14 , 2010).
13. Predictors of response will be sought according to baseline ( Day 1 ) blasts in bone marrow morphology / WHO and FAB classification , WBC, age, sex and other characteristics at diagnosis .

1. Supervivencia libre de evento (desde la administración de la primera dosis de tratamiento) al primer, segundo y tercer año, definiendo ?evento? como recaída o muerte por cualquier causa.
2. Supervivencia libre de enfermedad (desde la administración de la primera dosis de tratamiento) al primer, segundo y tercer año.
3. Supervivencia libre de recaída (desde la fecha de RC o RCi) al primer, segundo y tercer año.
4. Duración de la remisión.
5. Incidencia acumulada de recaída.
6. Supervivencia global al segundo y tercer año desde el inicio de tratamiento.
7. Calidad de vida de los pacientes evaluada mediante el cuestionario EQ-5D.
8. Uso de antibióticos, transfusiones, número y duración de las hospitalizaciones, número de días de asistencia al hospital de día.
9. Profundidad de la RC según el porcentaje de EMR, realizado tras los ciclos 3 (tras la fase de inducción) y 9 (tras la fase de consolidación) de tratamiento, en aquellos pacientes que hayan alcanzado RC o RCi.
10. Tasa de respuesta global tras 3 ciclos de tratamiento en los pacientes inicialmente tratados con la terapia experimental (azacitidina) frente a los pacientes tratados con la quimioterapia estándar (fludarabina y citarabina).
11. Mortalidad precoz (en los primeros 60 días).
12. Toxicidad hematológica y no hematológica (tipo, intensidad, frecuencia y gravedad) según los Criterios de Terminología Común de Acontecimientos Adversos del National Cancer Institute (Common Terminology Criteria for Adverse Events (CTCAE) del National Cancer Institute), versión 4.0. Published: May 28, 2009 (v4.03: June 14, 2010).
13. Se buscarán factores pronósticos de respuesta en función de los valores basales (Día 1) de blastos en médula ósea, morfología/clasificación WHO y FAB, leucocitos, edad, sexo y otras características al diagnóstico.

E.5.2.1

Timepoint(s) of evaluation of this end point

After cycles 3 and 9 of treatment.
At 1st, 2nd and 3rd year after treatment start.

Tras ciclos 3 y 9 de tratamiento.
Al primer, segundo y tercer año desde el inicio del tratamiento.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

UVUP

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

350

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

350

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Expected normal treatment.

Práctica clínica habitual.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2014-07-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-07-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-10-28

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