Clinical Trials Register

Summary
EudraCT Number:	2012-000233-39
Sponsor's Protocol Code Number:	IIBSP-CSF-2011-141
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2012-03-14
Trial 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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2012-000233-39

A.3

Full title of the trial

Tratamiento de la leucemia mieloide aguda de novo con la combinación de idarrubicina en dosis creciente, citarabina y sensibilización (?priming?) con G-CSF. Estudio prospectivo en fase I/II de toxicidad y eficacia

A.3.1

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

Tratamiento de la leucemia mieloide aguda de novo con la combinación de idarrubicina en dosis creciente, citarabina y G-CSF.

A.4.1

Sponsor's protocol code number

IIBSP-CSF-2011-141

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	Institut de Recerca de l?Hospital de la Santa Creu i Sant Pau
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	Beca Ministerio de Salud
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	Institut de Recerca HSCSP
B.5.2	Functional name of contact point	Romy Rodriguez
B.5.3	Address:
B.5.3.1	Street Address	C. Sant Antoni Mª Claret, 167
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08025
B.5.3.4	Country	Spain
B.5.4	Telephone number	349329190001969
B.5.5	Fax number	34935537812
B.5.6	E-mail	rrodriguezmu@santpau.cat

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	Zavedos
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER, S.L.
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	Zavedos
D.3.2	Product code	PR 1
D.3.4	Pharmaceutical form	Powder and solution for solution for injection
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	IDARUBICIN
D.3.9.1	CAS number	58957-92-9
D.3.9.2	Current sponsor code	PR1
D.3.9.3	Other descriptive name	Zalvedos
D.3.9.4	EV Substance Code	SUB08111MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	5 to 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.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

Leucemia Mieloide Aguda de novo

E.1.1.1

Medical condition in easily understood language

Leucemia Mieloide Aguda en primer diagnóstico

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	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10000835
E.1.2	Term	Acute leukemia
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Principal:
Identificar la dosis máxima de idarrubicina en combinación con citarabina y G-CSF que origina una tasa de RC igual o superior al 65% con toxicidad tolerable.

E.2.2

Secondary objectives of the trial

Toxicidad hematológica
Toxicidad gastrointestinal y hepática
Toxicidad cardiaca
Fiebre e infecciones
Complicaciones pulmonares
Duración de la hospitalización
Mortalidad en inducción y causas de muerte
Recaídas a los 6 meses de obtenida la RC
Supervivencia a los 9 meses del diagnóstico

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Se recogerán células y suero para almacenarlas en el Banco de Tumores y en la seroteca, de cara a futuros estudios, previo consentimiento por parte de los pacientes.

E.3

Principal inclusion criteria

Firma del consentimiento informado
Pacientes con LMA de nuevo diagnóstico, clasificada según los criterios de la OMS.
Edad mayor o igual a 18 años y menor o igual a 70 años.

E.4

Principal exclusion criteria

Pacientes tratados previamente por su LMA con quimioterapia distinta de hidroxiurea.
Leucemia promielocítica aguda con t(15;17).
Crisis blástica de la leucemia mieloide crónica.
Leucemias que aparecen después de otras neoplasias mieloproliferativas.
Leucemias que sobrevienen después de síndromes mielodisplásicos de más de 6 meses. presencia de otras enfermedades neoplásicas en actividad.
LMA secundarias a tratamiento quimio-radioterápico por otras neoplasias.
Funciones renal y hepática anormales, con cifra de creatinina y/o bilirrubina 2 veces superior al valor límite normal, excepto cuando la alteraciones sean atribuibles a la leucemia.
Pacientes con fracción de eyección muy disminuida (inferior al 45%), insuficiencia cardiaca sintomática, o ambas del valor normal del centro.
Pacientes con enfermedad neurológica o psiquiátrica grave concomitante.
Positividad para el VIH.
Pacientes embarazadas o en período de lactancia.

E.5 End points

E.5.1

Primary end point(s)

Obtención de la remisión completa (RC)

E.5.1.1

Timepoint(s) of evaluation of this end point

Día + 28 Post primera y segunda inducción (cuando aplique)

E.5.2

Secondary end point(s)

Toxicidad secundaria a la administración de idarrubicina:
Toxicidad hematológica (OMS)
Toxicidad gastrointestinal y hepática (OMS)
Toxicidad cardiaca (OMS)
Fiebre e infecciones
Complicaciones pulmonares (OMS)
Duración de la hospitalización
Mortalidad en inducción (MRT)
Recaídas a los 6 meses de la RC (incidencia acumulada) (RI)
Supervivencia a los 9 meses del diagnóstico (probabilidad actuarial) (SG)

E.5.2.1

Timepoint(s) of evaluation of this end point

Post inducción (1º y 2º cuando aplique, recaída), Mes 3, Mes 6 y visitas de seguimiento

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)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

Ensayo clínico fase I/II prospectivo, abierto, simple, multicéntrico, no aleatorizado, en 3 cohortes

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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)

E.8.2.2

Placebo

E.8.2.3

Other

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

Última de visita de seguimiento del último paciente

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

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)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

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)

Tratamiento postremisión habitual, según protocolo LMA-12 del grupo CETLAM

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

2012-05-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-04-13

P. End of Trial
P.	End of Trial Status	Ongoing

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials