Clinical Trials Register

Summary
EudraCT Number:	2014-001002-17
Sponsor's Protocol Code Number:	PVAB
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-06-03
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

Belgium - FPS Health-DGM

A.2

EudraCT number

2014-001002-17

A.3

Full title of the trial

A prospective phase II study of bendamustine in patients aged over 60 years with classical Hodgkin lymphoma treated by prednisone, vinblastine, and doxorubicin

Etude prospective de phase II évaluant la bendamustine chez des patients agés de plus de 60 ans atteints d'un lymphome de Hodgkin classique traités par prednisone, vinblastine et doxorubicine

A.3.1

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

Study of bendamustine in patients aged over 60 years with classical Hodgkin lymphoma treated by prednisone, vinblastine and doxorubicin

Etude évaluant la bendamustine chez des patients agés de plus de 60 ans atteints d'un lymphome de Hodgkin classique traités par prednisone, vinblastine et doxorubicine

A.3.2

Name or abbreviated title of the trial where available

PVAB

A.4.1

Sponsor's protocol code number

PVAB

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	LYSARC
B.1.3.4	Country	France
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	MundiPharma
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	LYSARC
B.5.2	Functional name of contact point	Fabienne Morand (Project Manager)
B.5.3	Address:
B.5.3.1	Street Address	Centre Hospitalier Lyon-Sud - Secteur Sainte Eugénie - Pavillon 6D
B.5.3.2	Town/ city	Pierre-Bénite Cedex
B.5.3.3	Post code	69495
B.5.3.4	Country	France
B.5.4	Telephone number	33(0)472 66 38 53
B.5.5	Fax number	33(0)4 26 07 40 13
B.5.6	E-mail	fabienne.morand@lysarc.org

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	LEVACT
D.2.1.1.2	Name of the Marketing Authorisation holder	ASTELLAS PHARMA GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
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	Bendamustine
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	3543-75-7
D.3.9.4	EV Substance Code	SUB00696MIG
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	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	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	LEVACT
D.2.1.1.2	Name of the Marketing Authorisation holder	ASTELLAS PHARMA GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
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	Bendamustine
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	3543-75-7
D.3.9.4	EV Substance Code	SUB00696MIG
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	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

first diagnosis of classical Hodgkin lymphoma according to WHO criteria excluding nodular lymphocyte predominant subtype

Premier diagnostic d'un lymphome de Hodgkin classique selon les critères de l'OMS à l'exception du sous-type prédominant de lymphocyte nodulaire

E.1.1.1

Medical condition in easily understood language

first diagnosis of classical Hodgkin lymphoma

Premier diagnostic d'un lymphome de Hodgkin classique

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10020328
E.1.2	Term	Hodgkin's lymphoma
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

The primary endpoint of the study is to assess the Complete Metabolic Response (CMR) rate at the final evaluation after completion of study treatment (after 6 cycles of study treatment or at premature treatment discontinuation) defined according to Lugano Classification (PET-CT-Based response).

E.2.2

Secondary objectives of the trial

The secondary endpoints are to evaluate:
- The feasibility of the protocol, with adequate protocol adherence (adequate dose without excessive delay).
- The safety profile including immediate toxicities and non-tumor events.
- Progression-free survival (PFS), disease-free survival (DFS) and overall survival (OS).
- The geriatric assessment program (G8, reduced IADL, ADL, CIRS-G, MNA, QLQ-C30 and QLQ-ELD14).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients must satisfy all following criteria to be enrolled in the study:
• Patient with a first diagnosis of classical Hodgkin lymphoma according to WHO criteria excluding nodular lymphocyte predominant subtype
• Age of 61 years or older
• No previous treatment for Hodgkin lymphoma
• Ann Arbor stages:
- II with mediastinum/thorax ≥0.33 or extranodal localization and with B symptoms
- Or III
- Or IV
• Baseline 18-FDG PET scan (PET0) performed before any treatment with at least one hypermetabolic lesion
• ECOG performance status 0-2
• Adequate cardio-pulmonary function with LVEF ≥ 50%
• Adequate renal function with creatinine clearance ≥ 40 mL/mn (MDRD formula)
• For patients aged 70 years old and more, a Mini Nutritional Assessment (MNA) ≥ 17
• A minimum life expectancy of 3 months
• Negative HIV, HBV (anti-HBc negativity) and HCV serologies tests ≤ 30 days before inclusion (except after vaccination)
• Having previously signed a written informed consent
• The patient must be covered by a social security system, if applicable
• Men patient must agree to use an adequate method of contraception during the study treatment and until 6 months after the end of the study treatment.

E.4

Principal exclusion criteria

Presence of any of the following will exclude a patient from enrollment:
• Any other type of lymphoma including nodular lymphocyte predominant subtype
• Any history of treated Hodgkin lymphoma
• Contra-indication to any drug contained in the chemotherapy regimens
• Any serious active disease (according to the investigator’s decision)
• Poor hepatic function (total bilirubin level > 30 μmol/L or transaminases > 2.5 maximum normal level) unless these abnormalities are related to the lymphoma
• Poor bone marrow reserve as defined by leukocytes < 2 G/L or platelets < 100 G/L, unless related to bone marrow infiltration
• Any history of cancer during the last 3 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. Patients previously diagnosed with prostate cancer are eligible if they fulfil all the followings:
(1) their disease was T1-T2a, N0, M0, with a Gleason score ≤ 7, and a prostate specific antigen (PSA) ≤ 10 ng/mL prior to initial therapy,
(2) they had definitive curative therapy (i.e. prostatectomy or radiotherapy) ≥ 2 years before Day 1 of Cycle 1,
(3) at a minimum 2 years following therapy, they had no clinical evidence of prostate cancer and their PSA was undetectable if they underwent prostatectomy or < 1 ng/mL if they did not undergo prostatectomy
• Severe metabolic disease interfering with normal application of protocol treatment as uncontrolled diabetes mellitus leading to impossibility to perform PET scan
• Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
• Adult under tutelage.

E.5 End points

E.5.1

Primary end point(s)

Complete Metabolic Response (CMR) Rate according to Lugano Classification (PET-CT-Based response).

E.5.1.1

Timepoint(s) of evaluation of this end point

at the end of study treatment (after 6 cycles of study treatment or at premature treatment discontinuation)

E.5.2

Secondary end point(s)

- Progression-free survival (PFS)
- Disease Free Survival (DFS)
- Overall survival (OS).
- Patient reported outcome and questionnaires (PRO) (G8, reduced IADL, ADL, CIRS-G, MNA, QLQ-C30 and QLQ-ELD14).
- safety

E.5.2.1

Timepoint(s) of evaluation of this end point

At the end of the follow up = 2 years

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

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

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

Yes

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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 receive the complete treatment will not be treated after the study, except in case of relapse.
Patients who withdraw from the study will receive a salvage therapy.

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

2015-06-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-09-28

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-11-10

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