Clinical Trials Register

Summary
EudraCT Number:	2011-002787-25
Sponsor's Protocol Code Number:	GIMEMACML0811
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-02-27
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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-002787-25

A.3

Full title of the trial

The protein tyrosine kinase inhibitor nilotinib as first-line treatment of Ph+, BCR-ABL+ chronic myeloid leukemia (CML) in early chronic phase: a phase IIIb, multicenter study of complete molecular response

Terapia di prima linea della Leucemia Mieloide Cronica Philadelphia positiva (LMC Ph pos) in fase cronica con l`™ inibitore delle tirosino chinasi (Nilotinib). Studio multicentrico di fase IIIb per verificare la completa risposta molecolare

A.3.1

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

A muulticenter study to evaluate drug response for the treatment of a white blood cell cancer in early chronic phase

Studio che coinvolge piu' centri mirato a valutare la risposta ad un farmaco per il trattamento di una forma di cancro dei globuli bianchi in fase cronica all’esordio

A.3.2

Name or abbreviated title of the trial where available

GIMEMA CML0811

A.4.1

Sponsor's protocol code number

GIMEMACML0811

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	G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO
B.1.3.4	Country	Italy
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	Associazione Italiana contro le Leucemie
B.4.2	Country	Italy
B.4.1	Name of organisation providing support	Novartis
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fondazione GIMEMA Onlus
B.5.2	Functional name of contact point	Centro Dati
B.5.3	Address:
B.5.3.1	Street Address	Via Casilina, 5
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00182
B.5.3.4	Country	Italy
B.5.4	Telephone number	06 70390526
B.5.5	Fax number	06 70390540
B.5.6	E-mail	gimema@gimema.it

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.2.1.2	Country which granted the Marketing Authorisation	Italy
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	EU/3/06/375
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Capsule, hard
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	NILOTINIB HYDROCHLORIDE MONOHYDRATE
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	AMN107
D.3.9.4	EV Substance Code	NA
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	150
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	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.2.1.2	Country which granted the Marketing Authorisation	Italy
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	EU/3/06/375
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Capsule, hard
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	NILOTINIB HYDROCHLORIDE MONOHYDRATE
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	AMN107
D.3.9.4	EV Substance Code	NA
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	200
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

Ph+, BCR-ABL+ chronic myeloid leukemia (CML) in early chronic phase

Leucemia mieloide cronica Ph+, BCR-ABL+ in fase cronica precoce

E.1.1.1

Medical condition in easily understood language

White blood cell cancer in early chronic phase

Cancro dei globuli bianchi in fase cronica all’esordio

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	10054352
E.1.2	Term	Chronic phase chronic myeloid 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

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the efficacy of nilotinib, 300 mg twice daily with dose increase to 400 mg twice daily in case of suboptimal response or failure (excluding patients who will fail for progression to ABP), in a population of patients with Ph-positive, BCR-ABL positive CML in early CP

Valutare l’efficacia del nilotinib, 300 mg 2 volte al giorno (BID), con incremento della dose a 400 mg BID in caso di risposta sub-ottimale o fallimento (ad esclusione dei pazienti che avranno fallito per progressione a fase accelerata/blastica), in una popolazione di pazienti con LMC Ph+, BCR-ABL+, in FC precoce.

E.2.2

Secondary objectives of the trial

- the assessment of the treatment safety; - the evaluation of complete cytogenetic response (CCgR) rates and kinetics of molecular response; - the estimation of the overall survival (OS), the progression-free survival (PFS), the failure-free survival (FFS) and the event-free survival (EFS); - the assessment of the patient reported quality of life.

- Valutazione della sicurezza della terapia; - Valutazione del tasso di risposta citogenetica completa (CCgR) e della cinetica della risposta molecolare; - Valutazione della sopravvivenza globale (OS), della sopravvivenza libera da progressione (PFS), della sopravvivenza libera da fallimento (FFS) e della sopravvivenza libera da evento (EFS); - Valutazione della qualità di vita riportata dal paziente.

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

LIFE QUALITY:
Vers:1
Date:2011/06/09
Title:Quality of life assessment
Objectives:Primary: To prospectively describe patients’ QoL over time Secondary: -To depict the baseline patients’ QoL profile in relation to clinical and laboratory values. -To investigate the prognostic value of baseline and early changes of QoL (i.e. from baseline to 3rd month) for mid to long term QoL outcomes. -To investigate the prognostic value of baseline and early changes of QoL (i.e. from baseline to 3rd month) for mid to long term traditional clinical outcomes (including CMR, CCgR, PFS, FFS and OS). -To investigate self-reported adherence and relationships with QoL and clinical “objective” outcomes.

QUALITA DELLA VITA:
Vers:1
Data:2011/06/09
Titolo:Valutazione della Qualità della Vita
Obiettivi:Primario: descrivere la qualità della vita dei pazienti prospetticamente Secondari: - Delineare la qualità della vita dei pazienti al basale in relazione ai valori clinici e di laboratorio. - Studiare il valore prognostico del basale e i cambiamenti precoci di qualità di vita (es: dal basale fino al terzo mese) per gli outcome di qualità di vita da medio a lungo termine. - Studiare il valore prognostico del basale e i cambiamenti precoci di qualità di vita (es: dal basale fino al terzo mese) per gli outcome clinici tradizionali da medio a lungo termine (inclusi CMR, CCgR, PFS, FFS e OS). - Studiare l’aderenza riportata dal paziente e le relazioni con la qualità di vita e gli outcome clinici obiettivi.

E.3

Principal inclusion criteria

- Age ≥ 18 - Male or female patients with diagnosis of Ph+ and/or BCR-ABL+ CML - Early chronic phase (within 6 months from diagnosis) - Pretreatment with Hydroxyurea or Anagrelide for a duration of up to 3 months and/or pretreatment with Imatinib for up to 30 days are permitted - Normal serum levels of potassium, magnesium, total calcium corrected for serum albumin or phosphorus, or correctable to within normal limits with supplements prior to the first dose of study medication - Written informed consent prior to any study procedures being performed - AST and ALT ≤ 2.5 x ULN or ≤ 5.0 x ULN if considered due to leukaemia - Alkaline phosphatase ≤ 2.5 x ULN unless considered due to leukaemia - Total direct bilirubin ≤ 1.5 x ULN, except know Mb. Gilbert - Serum creatinine ≤ 1.5 x ULN

- Età ≥ 18 anni - Pazienti di sesso maschile o femminile con diagnosi di LMC Ph+ e/o BCR-ABL+ - Fase cronica precoce (entro 6 mesi dalla diagnosi) - Sono permessi un pre-trattamento con idrossiurea o anagrelide per una durata massima di 3 mesi e/o un pre-trattamento con imatinib fino a un massimo di 30 giorni - Livelli sierici di potassio, magnesio, fosforo, calcio totale corretto per l’albumina sierica o per il fosforo, normali o correggibili entro i valori normali con integratori prima della prima dose del farmaco in studio - Consenso informato scritto prima dell’esecuzione di qualunque procedura relativa allo studio - AST e ALT ≤ 2.5 x valore massimo della normalità o ≤ 5.0 x valore massimo della normalità se considerato secondario alla leucemia - Fosfatasi alcalina ≤ 2.5 x valore massimo della normalità, salvo venga considerato secondario alla leucemia - Bilirubina diretta ≤ 1.5 x valore massimo della normalità, salvo i casi con Morbo di Gilbert noto - Creatinina sierica ≤ 1.5 x valore massimo della normalità

E.4

Principal exclusion criteria

- Known impaired cardiac function, including any of the following: - LVEF < 45% - Complete left bundle branch block - Right bundle branch block plus left anterior hemiblock, bifascicular block - Use of a ventricular-paced pacemaker - Congenital long QT syndrome - History of or presence of clinically significant ventricular or atrial tachyarrhythmias - Clinically significant resting bradycardia (<50 beats per minute) - QTc>450 msec on screening ECG. If QTc > 450 msec and electrolytes are not within normal ranges before Nilotinib dosing, electrolytes should be corrected and then the patient rescreened for QTc criterion. - Myocardial infarction within 12 months prior to starting study drugs - Other clinical significant heart disease (e.g. unstable angina, congestive heart failure, uncontrolled hypertension) - Serum lipase and amylase > 1.5 x ULN (upper limit of normal) or history of acute (i.e., within 1 year of starting study medication) or chronic pancreatitis - Other concurrent uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infections, acute or chronic liver and renal disease) that could cause unacceptable safety risks or compromise compliance with the protocol - Impaired gastrointestinal function or disease that may alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting and diarrhea, malabsorption syndrome, small bowel resection or gastric by-pass surgery) - Concomitant medications with potential QT prolongation - Concomitant medications known to interact with CYP450 isoenzymes (CYP3A4, CYP2C9, and CYP2C8) - Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy - Patients who are pregnant or breast feeding, or women of reproductive potential not employing an effective method of birth control. (Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to administration of nilotinib). - Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention. - Patients unwilling or unable to comply with the protocol.

- Alterazione nota della funzionalità cardiaca, inclusa una qualunque delle seguenti condizioni: - Frazione di eiezione del ventricolo sinistro < 45% - Blocco di branca sinistro completo - Blocco di branca destro associato a emiblocco anteriore sinistro, blocco bifascicolare - Uso di un pace-maker ventricolare - Sindrome del QT lungo congenita - Storia o presenza di tachiaritmie atriali o ventricolari clinicamente significative - Bradicardia a riposo clinicamente significativa (< 50 battiti/minuto) QTc > 450 msec all’ECG di screening. Se QTc > 450 msec in presenza di elettroliti sierici alterati, è opportuno correggere gli elettroliti e quindi ripetere lo screening per il QTc - Infarto del miocardio nei 12 mesi precedenti l’inizio del farmaco in studio - Altre patologie cardiache clinicamente significative (es. angina instabile, scompenso cardiaco congestizio, ipertensione non controllata) - Amilasi e lipasi sieriche > 1.5 x valore massimo della normalità o storia di pancreatite acuta (es. nei 12 mesi precedenti l’inizio del farmaco in studio) o pancreatite cronica - Altre concomitanti condizioni mediche non controllate (es. diabete non controllato, infezioni attive o non controllate, patologie epatiche o renali acute o croniche) che possano determinare rischi non accettabili per la sicurezza del paziente o che possano compromettere l’aderenza al protocollo - Alterata funzionalità gastrointestinale o patologie che possano alterare l’assorbimento del farmaco in studio (es. malattie ulcerose, nausea incontrollata, vomito, diarrea, sindrome da malassorbimento, resezione del piccolo intestino, o chirurgia con by-pass gastrico) - Farmaci concomitanti con potenziale prolungamento del tratto QT - Farmaci concomitanti noti per avere interazioni con gli isoenzimi del CYP450 (CYP3A4, CYP2C9, and CYP2C8) - Pazienti sottoposti a chirurgia maggiore nelle 2 settimane precedenti l’inizio del farmaco in studio o che non abbiano ancora recuperato dagli effetti collaterali di tali interventi - Pazienti che siano in gravidanza o in allattamento, o donne in età fertile che non utilizzino un efficace metodo anticoncezionale (le donne in età fertile devono avere un test di gravidanza negativo entro le 48 ore precedenti la somministrazione della prima dose di nilotinib) - Pazienti con storia di un’altra neoplasia maligna primitiva che attualmente sia clinicamente significativa o richieda provvedimenti terapeutici - Pazienti non aderenti alla terapia o non in grado di aderire alle procedure del protocollo.

E.5 End points

E.5.1

Primary end point(s)

To assess the complete molecular response (CMR4) rate at 24 months of treatment.

Valutare il tasso di risposta molecolare completa (CMR4) del trattamento a 24 mesi.

E.5.1.1

Timepoint(s) of evaluation of this end point

After 24 months of treatment

Dopo 24 mesi di trattamento

E.5.2

Secondary end point(s)

- The toxicity and the compliance to treatment - The complete cytogenetic response (CCgR) rate at 3, 6, 12, 18 and 24 months; - The rate and the degree of molecular response at 3, 6, 12, 18 and 24 months; - The time to CCgR, the time to MMR and the time to CMR; - Overall Survival (OS), from the date of the first nilotinib dose to death, Progression Free Survival (PFS), from the date of the first nilotinib dose to progression to AP or BP or death, Failure Free Survival (FFS) from the date of the first nilotinib dose to failure or progression or death, Event Free Survival (EFS) from the date of the first nilotinib to any event, including treatment discontinuation for adverse events, failure, progression to AP or BP, or death, whichever comes first. Failure is defined according to ELN 2009 criteria4. - Patient-reported quality of life (QoL) at baseline and then at 3, 6, 12, 18 and 24 months.

- La tossicità e l’aderenza al trattamento - Il tasso di risposta citogenetica completa a 3, 6, 12, 18 e 24 mesi; - Il tasso ed il grado di risposta molecolare a 3, 6, 12, 18 e 24 mesi; - Il tempo alla CCgR, MMR e CMR; - Overall Survival (OS), dalla data di prima somministrazione di nilotinib fino al decesso, Progression Free Survival (PFS), dalla data di prima somministrazione di nilotinib alla progressione a AP o BP o decesso, Failure Free Survival (FFS) dalla data di prima somministrazione di nilotinib fino a fallimento, progressione o decesso, Event Free Survival (EFS) dalla data di prima somministrazione di nilotinib fino a qualsiasi evento, incluso l’interruzione del trattamento per eventi avversi, fallimento, progressione a AP o BP, o decesso, qualunque si verifichi prima. Il fallimento è definito secondo ELN 2009 criteria4. - Qualità della vita riportata dal paziente al basale e poi a 3, 6, 12, 18 e 24 mesi.

E.5.2.1

Timepoint(s) of evaluation of this end point

During and at the end of the treatment

Durante ed alla fine del trattamento

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

Yes

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

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)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

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

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

Number of subjects for this age range:

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

120

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)

Patients who are in CMR (CMR4), will be offered to continue the study drug free-of-charge until the responsible physician and the patient will consider this in the best interest of the patient. For all patients who will not be in CMR (CMR4) at 24 months, the choice of the subsequent treatment will be up to the physician. However, all patients, whether or not in CMR, will be followed-up for at least 5 years.

Ai pazienti che sono in Remissione molecolare completa (CMR4) sarà proposto di continuare lo studio senza spese di farmaco secondo giudizio dello sperimentatore. Per tutti i pazienti che non saranno in Remissione molecolare completa (CMR4) a 24 mesi, sarà lo sperimentatore a decidere ulteriori trattamenti. Comunque tutti i pazienti, siano essi in Remissione molecolare completa o meno, saranno seguiti per almeno 5 anni.

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

2011-09-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-09-13

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-11-30

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