Clinical Trials Register

Summary
EudraCT Number:	2011-001246-14
Sponsor's Protocol Code Number:	701
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:	2012-03-16
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-001246-14

A.3

Full title of the trial

Phase II multicentric study to evaluate the efficacy and the safety of Bendamustine in adjunct to Etoposide, Aracytabin and Melphalan (BeEAM) as a preparative regimen for autologous stem cell transplantation in refractory/relapsed aggressive B-cell non-Hodgkin lymphoma patients.

Studio di fase II, multicentrico, per valutare la sicurezza e l'efficacia di Bendamustina in aggiunta a Etoposide, Citosina Arabinoside e Melphalan come regime di condizionamento al trapianto autologo in pazienti affetti da linfoma non-Hodgkin B aggressivo ricaduti/resistenti.

A.3.1

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

study to evaluate the efficacy of a preparative regimen for transplantation in refractory/relapsed non-Hodgkin lymphoma patients.

Studio per valutare l'efficacia di un regime di condizionamento al trapianto autologo nei pazienti con linfoma non-Hodgkin B aggressivo

A.4.1

Sponsor's protocol code number

701

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	AZIENDA OSPEDALIERA OSPEDALE S. SALVATORE
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	Presidio Ospedaliero“San Salvatore/Ospedali Riuniti Marche Nord”
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	Presidio Ospedaliero“San Salvatore/Ospedali Riuniti Marche Nord”
B.5.2	Functional name of contact point	Hematology Clinical Trial Office
B.5.3	Address:
B.5.3.1	Street Address	Via Lombroso, 1
B.5.3.2	Town/ city	Pesaro
B.5.3.3	Post code	61122
B.5.3.4	Country	Italy
B.5.4	Telephone number	+390721364022
B.5.5	Fax number	+390721364052
B.5.6	E-mail	a.isidori@ospedalesansalvatore.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.2.1.1.1	Trade name	LAVACT
D.2.1.1.2	Name of the Marketing Authorisation holder	Astellas Pharma GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Powder 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	BENDAMUSTINE HYDROCHLORIDE
D.3.9.1	CAS number	3543757
D.3.10	Strength
D.3.10.1	Concentration unit	mg/l milligram(s)/litre
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	2.5
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

Adult agressive B-cell non-Hodgkin lymphoma patients.

Pazienti affetti da linfoma non-Hodgkin B aggressivo refrattario al trattamento o in recidiva dopo almeno un ciclo di chemioterapia

E.1.1.1

Medical condition in easily understood language

Aggressive lymphoma

Linfoma aggressivo

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	HLGT
E.1.2	Classification code	10025320
E.1.2	Term	Lymphomas non-Hodgkin's B-cell
E.1.2	System Organ Class	10005329 - Blood and lymphatic system disorders

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	10012821
E.1.2	Term	Diffuse large B-cell lymphoma recurrent
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	SOC
E.1.2	Classification code	10005329
E.1.2	Term	Blood and lymphatic system disorders
E.1.2	System Organ Class	10005329 - Blood and lymphatic system disorders

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	10012822
E.1.2	Term	Diffuse large B-cell lymphoma refractory
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

To assess the 1-year complete remission (CR) rate.

Valutare il tasso di risposte complete a 1 anno di distanza dalla somministrazione di chemioterapia con Bendamustina, Citosina Arabinoside, Etoposide, Melphalan

E.2.2

Secondary objectives of the trial

• To assess the safety of the regimen
• To assess the disease-free survival
• To assess the overall survival

Valutare la sicurezza del regime
Valutare la sopravvivenza libera da malattia
valutare la sopravvivenza globale

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Aggressive B-Cell non-Hodgkin lymphoma patients either resistant or relapsed
• Age >18 and <70 years
• Signed Informed Consent
• Karnofsky score > 70%
•Adequate hematologic, renal, pulmonary and hepatic function.

- Firma del Consenso Informato.
- Diagnosi di linfoma Non-Hodgkin B refrattario al trattamento o in recidiva dopo almeno un ciclo di chemioterapia.
- Età ≥18 e ≤ 70 anni.
- Karnofsky > 70% o WHO score ≤ 1 .
- Normale funzionalità renale, polmonare ed epatica.

E.4

Principal exclusion criteria

• HIV infection
• HCV positivity
•Secondary lymphoma following prior chemotherapy/ radiotherapy or an
active second malignancy
• Pregnancy or nursing
•Absence of patient’s written informed consent
• Current uncontrolled infections
•Intercurrent organ damage or medical problems that would interfere with therapy

- Infezione da HIV.
- Infezione da HCV.
- Linfoma secondario successivo a chemioterapia/radioterapia.
- Gravidanza/allatamento.
- Assenza di consenso informato scritto
- Infezione attiva non controllata
- Danno d'organo intercorrente che potrebbe interferire con la terapia

E.5 End points

E.5.1

Primary end point(s)

To assess the 1-year complete remission (CR) rate.

Valutare il tasso di risposte complete a 1 anno di distanza dalla somministrazione di chemioterapia con Bendamustina, Citosina Arabinoside, Etoposide, Melphalan

E.5.1.1

Timepoint(s) of evaluation of this end point

1-year

1 anno dalla chemioterapia

E.5.2

Secondary end point(s)

• To assess the safety of the regimen
• To assess the disease-free survival
• To assess the overall survival

Valutare la sicurezza del regime
Valutare la sopravvivenza libera da malattia
valutare la sopravvivenza globale

E.5.2.1

Timepoint(s) of evaluation of this end point

100 days (safety)
3-years (event-free and overall survival).

100 giorni dal trapianto (sicurezza)
3 anni (sopravvivenza libera da malattia e globale)

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)

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

Yes

E.8.1.1

Randomised

E.8.1.2

Open

Yes

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

Yes

E.8.2.3.1

Comparator description

terapia convenzionale

conventional therapy

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

100

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)

what usually expected for that condition

quelli normalmente previsti per la loro patologia di base

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

2011-06-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-03-23

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

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