Clinical Trials Register

Summary
EudraCT Number:	2005-002476-15
Sponsor's Protocol Code Number:	GIMEMALLC0405
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:	2006-01-03
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

2005-002476-15

A.3

Full title of the trial

Phase II pilot trial to evaluate the efficacy and safety of a first-line combined therapeutic approach for young (> = 60 years old) CLL patients with advanced and progressive disease stratified according to the biological prognostic features. GIMEMA LLC0405. EudraCT Number 2005-002476-15.

Studio pilota di fase II per la valutazione di una strategia terapeutica diversificata sulla base del profilo biologico in pazienti con Leucemia Linfatica Cronica (LLC) in stadio avanzato e/o malattia progressiva di eta` < = 60 anni. Protocollo GIMEMA LLC0405. EudraCT Number 2005-002476-15.

A.4.1

Sponsor's protocol code number

GIMEMALLC0405

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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	MABCAMPATH*EV 3F 3ML 10MG/ML
D.2.1.1.2	Name of the Marketing Authorisation holder	SCHERING SpA *
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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
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	Alemtuzumab
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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

CLL patients (diagnosis of CLL according to NCI criteria) with the following characteristics: Advanced stage or progressive disease with at least 2 clinical features of activity. Previously untreated patients. Age <=18 to >=60.

LEUCEMIA LINFATICA CRONICA in stadio avanzato o progressiva con almeno 2 segni clinici di attivita'. Assenza di precedente chemioterapia. Eta' lt;=18 anni fino a gt;=60 anni.

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10008958
E.1.2	Term	Chronic lymphocytic leukaemia
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

Valutare l`attività del trattamento assegnato in termini di risposta completa e risposta parziale (RC, RP) nei due diversi gruppi stratificati in base al profilo biologico alla diagnosi.

E.2.2

Secondary objectives of the trial

Valutare la tossicità in rapporto ai diversi approcci terapeutici previsti nello studio.Valutare la durata della sopravvivenza,della sopravvivenza libera da eventi,della sopravvivenza libera da malattia.Valutare la correlazione tra le caratteristiche cliniche e biologiche della malattia,la risposta terapeutica e la soppravivenza.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

E.4

Principal exclusion criteria

E.5 End points

E.5.1

Primary end point(s)

Primari Per entrambi i gruppi di stratificazione, l`obbiettivo primario ¨¨ la percentuale di risposta (RC+RP), valutata come di seguito specificato. Pazienti a basso rischio La risposta verrà valutata dopo 4 cicli Flu/Cy. - I pazienti che avranno raggiunto la risposta (RP, RC) dopo i primi 4 cicli di FluCy, eseguiranno altri 2 cicli di FluCy per un totale di 6 cicli. - I pazienti che invece non avranno ottenuto la risposta (RP, RC) saranno avviati alla terapia con Campath-1H sottocute. Pazienti ad alto rischio La risposta verrà valutata dopo 4 cicli Flu/Campath. Secondari Come obbiettivo secondario, verrà considerato il tipo di risposta (clinica, citometrica, molecolare), come percentuale totale e fra i soli rispondenti. Verranno inoltre valutate le percentuali di rispondenti alle diverse fasi di induzione e, se prevista dal protocollo, di post-induzione (compreso l`eventuale trapianto), in relazione alla risposta ottenuta nella fase precedente. L`incidenza di tossicità (ematologica, extra-ematologica, infezioni) verrà valutata rispetto al totale dei pazienti sottoposti a ciascun tipo di trattamento (terapia di induzione, trapianto allo genico, autologo e Campath-1H). Lo status del paziente a due anni dalla diagnosi verrà valutato utilizzando tecniche di analisi di sopravvivenza e di rischi competitivi. A fini descrittivi, verranno inoltre calcolate le percentuali di ciascun tipo di risposta sul totale dei soggetti sopravviventi e fra i soli rispondenti a due anni.

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)

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)

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.8.3

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

Information not present in EudraCT

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

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	No
F.1.1	Number of subjects for this age range:	0
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	No
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	Yes
F.3.3.2	Women of child-bearing potential using contraception	No
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	80

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

2005-06-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2005-07-28

P. End of Trial
P.	End of Trial Status	Completed

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