Clinical Trials Register

Summary
EudraCT Number:	2020-002935-30
Sponsor's Protocol Code Number:	20-01434
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-11-09
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

Germany - BfArM

A.2

EudraCT number

2020-002935-30

A.3

Full title of the trial

Venetoclax in combination with the BTK inhibitor Ibrutinib and Rituximab or conventional chemotherapy (Bendamustine) and Ibrutinib and Rituximab in patients with treatment naive Mantle Cell Lymphoma not eligible for high dose therapy.

Venetoclax in Kombination mit dem BTK Inhibitor Ibrutinib und Rituximab oder konventionelle Chemotherapie (Bendamustin) und Ibrutinib und Rituximab zur Behandlung eines unbehandelten Mantelzell-Lymphoms bei Patienten, die nicht für eine Hochdosistherapie geeignet sind.

A.3.1

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

Venetoclax in combination with Ibrutinib and Rituximab or conventional chemotherapy (Bendamustine) and Ibrutinib and Rituximab in patients with Mantle Cell Lymphoma.

Venetoclax in Kombination mit Ibrutinib und Rituximab oder konventionelle Chemotherapie (Bendamustin) und Ibrutinib und Rituximab bei Patienten mit Mantelzell-Lymphoms.

A.3.2

Name or abbreviated title of the trial where available

MCL elderly III

A.4.1

Sponsor's protocol code number

20-01434

A.5.4

Other Identifiers

Name:

EU CT

Number:

2022-501808-96-00

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	University Medical Center of the Johannes Gutenberg-University Mainz
B.1.3.4	Country	Germany
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	AbbVie Inc.
B.4.2	Country	Germany
B.4.1	Name of organisation providing support	Janssen Pharmaceutica NV
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	University Medical Center of the Johannes Gutenberg-University Mainz
B.5.2	Functional name of contact point	Univ.-Prof. Dr. med. Georg Hess
B.5.3	Address:
B.5.3.1	Street Address	Langenbeckstr. 1
B.5.3.2	Town/ city	Mainz
B.5.3.3	Post code	55131
B.5.3.4	Country	Germany
B.5.4	Telephone number	+496131175040
B.5.5	Fax number	+49613117475040
B.5.6	E-mail	SPO@izks-mainz.de

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	IMBRUVICA®140 mg Filmtabletten
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen-Cilag International NV
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Film-coated tablet
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	Ibrutinib
D.3.9.1	CAS number	936563-96-1
D.3.9.3	Other descriptive name	Imbruvica
D.3.9.4	EV Substance Code	SUB120863
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	140
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	Yes
D.3.11.13.1	Other medicinal product type	Antineoplastic agents, protein kinase inhibitors
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	Venclyxto® 10 mg Filmtabletten
D.2.1.1.2	Name of the Marketing Authorisation holder	AbbVie Deutschland GmbH & Co. KG
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Film-coated tablet
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	Venetoclax
D.3.9.3	Other descriptive name	Venclyxto
D.3.9.4	EV Substance Code	SUB176260
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	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	Yes
D.3.11.13.1	Other medicinal product type	other antineoplastic agents
D.IMP: 3
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	Venclyxto® 50 mg Filmtabletten
D.2.1.1.2	Name of the Marketing Authorisation holder	AbbVie Deutschland GmbH & Co. KG
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Film-coated tablet
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	Venetoclax
D.3.9.3	Other descriptive name	Venclyxto
D.3.9.4	EV Substance Code	SUB176260
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	50
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	Yes
D.3.11.13.1	Other medicinal product type	other antineoplastic agents
D.IMP: 4
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	Venclyxto® 100 mg Filmtabletten
D.2.1.1.2	Name of the Marketing Authorisation holder	AbbVie Deutschland GmbH & Co. KG
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Film-coated tablet
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	Venetoclax
D.3.9.3	Other descriptive name	Venclyxto
D.3.9.4	EV Substance Code	SUB176260
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	Yes
D.3.11.13.1	Other medicinal product type	other antineoplastic agents

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

Mantle Cell Lymphoma

Mantelzell-Lymphom

E.1.1.1

Medical condition in easily understood language

malignant lymph node disease

bösartige Lymphknotenerkrankung

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	10026799
E.1.2	Term	Mantle cell lymphoma NOS
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

To evaluate efficacy in both treatment arms:
- Failure-Free Survival (FFS) at 30 months

Beurteilung der Wirksamkeit in beiden Behandlungsarmen:
- Eventfreies Überleben (FFS) nach 30 Monaten

E.2.2

Secondary objectives of the trial

To evaluate efficacy, safety, tolerability, and quality of life in both treatment arms:
- Failure-free survival (continuous observation)
- Progression-free survival
- Complete Remission rate (CR) and overall response rate (ORR: CR, PR) four weeks after the end of induction therapy
- best response, time to best response, time to first response
- overall survival
- Overall survival of patients divided according to the geriatric categories and treatment received
- Safety: adverse events, tolerability
- Quality of life during induction and maintenance therapy (assessed using the EORTC QLQ-C30 and the EORTC QLQ-NHL-HG29)
- Molecular remission after induction and conversion during maintenance (exploratory)
- Immune reconstitution, e.g. persistence of anti-Covid19 immunity
- safety and efficacy in different geriatric categories

Beurteilung der Wirksamkeit, Sicherheit, Verträglichkeit und Lebensqualität in beiden Behandlungsarmen:
- Eventfreies Überleben (kontinuierliche Beobachtung)
- Progressionsfreies Überleben
- Komplette Remissionsrate (CR) und Gesamtansprechrate (ORR: CR, PR) vier Wochen nach Ende der Induktionstherapie
- Bestes Ansprechen, Zeit bis zum besten Ansprechen, Zeit bis zum ersten Ansprechen
- Gesamtüberlebensdauer
- Sicherheit: unerwünschte Ereignisse, Verträglichkeit
- Lebensqualität während der Induktions- und Erhaltungstherapie (bewertet mit dem EORTC QLQ-C30 und dem EORTC QLQ-NHL-HG29)
- Molekulare Remission nach Induktion und Konversion während der Erhaltungstherapie (explorativ)
- Immunrekonstitution, z. B. Persistenz der Anti-Covid19-Immunität
- Wirksamkeit und Sicherheit in verschiedenen geriatrischen Kategorien

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Histologically confirmed diagnosis of MCL according to WHO classification
- previously untreated stage II-IV (Ann Arbor)
- ≥ 60 years and not suitable for autologous SCT
- At least 1 measurable lesion; in case of bone marrow infiltration only, bone marrow aspiration and biopsy is mandatory for all staging evaluations.
- ECOG performance status ≤ 2
The following laboratory values at screening (unless related to MCL):
- Absolute neutrophil count (ANC) ≥ 1000 cells/μL
- Platelets ≥75.000 cells/μL
- Transaminases (AST and ALT) ≤3 x ULN
- Total bilirubin ≤ 2 x ULN unless other reason known (Gilbert-Meulengracht-Syndrome)
- Creatinine ≤ 2 mg/dL or eGFR ≥ 50 mL/min
- Written informed consent form according to ICH/EU GCP and national regulations
- Sexually active men with female partners of child-bearing potential potential must agree to use highly effective contraceptives

- Histologisch bestätigte Diagnose von MCL gemäß WHO-Klassifikation
- Bisher unbehandeltes Stadium II-IV (Ann Arbor)
- ≥ 60 Jahre und nicht für eine autologe ASZT geeignet
- Mindestens 1 messbare Läsion; ausschließlich im Falle einer Knochenmarkinfiltration ist eine Knochenmarkaspiration und -biopsie für alle Staging-Bewertungen obligatorisch.
- ECOG ≤ 2
Die folgenden Laborwerte beim Screening (sofern nicht auf MCL bezogen):
- Absolute Neutrophilenzahl (ANC) ≥ 1000 Zellen/µL
- Thrombozyten ≥75.000 Zellen/µL
- Transaminasen (AST und ALT) ≤3 x ULN
- Gesamtbilirubin ≤ 2 x ULN, sofern kein anderer Grund bekannt ist (Gilbert-Meulengracht-Syndrom)
- Kreatinin ≤ 2 mg/dL oder eGFR ≥ 50 mL/min
- Schriftliche Einverständniserklärung gemäß ICH/EU GCP und nationalen Vorschriften
- Sexuell aktive Männer mit Partnerinnen im gebärfähigen Alter müssen sich verpflichten, hochwirksame Verhütungsmittel zu verwenden .

E.4

Principal exclusion criteria

- Major surgery within 4 weeks prior to first dose
- Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon)
- History of stroke or intracranial hemorrhage within 6 months prior to first dose
- Treatment with strong or moderate CYP3A4/5 inhibitors/inducers within 7 days before first dose and during Venetoclax and Ibrutinib intake
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of Ibrutinib capsules, or put the study outcomes at undue risk
- Vaccinated with live, attenuated vaccines within 4 weeks prior to first dose
- Known CNS involvement of MCL
- Known bleeding disorder (e.g. von Willebrand disease; hemophilia)
Serious concomitant disease interfering with a regular therapy according to the study protocol:
- Cardiac (Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification or LVEF below LLN)
- Pulmonary (e.g. chronic lung disease with hypoxemia, e.g. DLCO ≤ 65% or FEV1 ≤ 65%)
- Endocrinological (e.g. severe, not sufficiently controlled diabetes mellitus)
- Patients with unresolved hepatitis B or C infection or known HIV positive infection (mandatory test)
Concomitant or previous malignancies within the last 3 years other than basal cell skin cancer, Prostate cancer in remission with PSA within normal range or in situ uterine cervix cancer.

- Schwerwiegende Operation innerhalb von 4 Wochen vor erster Dosis
- Erforderte Antikoagulation mit Warfarin oder gleichwertigen Vitamin-K-Antagonisten (z. B. Phenprocoumon)
- Vorgeschichte eines Schlaganfalles oder einer intrakraniellen Blutung innerhalb der letzten 6 Monate vor erster Dosis
- Behandlung mit starken oder moderaten CYP3A4/5-Inhibitoren/Induktoren innerhalb der letzten 7 Tage vor Gabe der ersten Dosis und während der Einnahme von Venetoclax und Ibrutinib
- Jede lebensbedrohliche Krankheit, jede Erkrankung oder jede Funktionsstörung eines Organsystems, die nach Ansicht des Prüfarztes, die Sicherheit des Probanden gefährden, die Absorption oder den Metabolismus von Ibrutinib-Kapseln beeinträchtigen oder die Ergebnisse der Studie in unangemessener Weise gefährden könnte
- Geimpft mit abgeschwächten Lebendimpfstoffen innerhalb der letzten 4 Wochen vor erster Dosis
- Bekannte ZNS-Beteiligung von MCL
- Bekannte Blutungsstörung (z. B. von-Willebrand-Krankheit, Hämophilie)
Schwerwiegende Begleiterkrankung, die eine reguläre Therapie gemäß dem Studienprotokoll beeinträchtigen:
- Kardial (klinisch signifikante kardiovaskuläre Erkrankungen wie unkontrollierte oder symptomatische Arrhythmien, kongestive Herzinsuffizienz oder Myokardinfarkt innerhalb der letzten 6 Monate vor dem Screening oder eine Herzerkrankung der Klasse 3 (mittelschwer) oder Klasse 4 (schwer) gemäß der funktionellen Klassifikation der New York Heart Association oder ein LVEF unter LLN)
- Pulmonal (z. B. chronische Lungenerkrankung mit Hypoxämie, z. B. DLCO ≤ 65 % oder FEV1 ≤ 65 %)
- Endokrinologisch (z. B. schwerer, nicht ausreichend eingestellter Diabetes mellitus)
- Patienten mit ungeklärter Hepatitis-B- oder -C-Infektion oder bekannter HIV-Infektion (obligatorischer Test)
Begleitende oder frühere bösartige Erkrankungen innerhalb der letzten 3 Jahre, ausgenommen Basalzell-Hautkrebs, Prostatakrebs in Remission mit PSA im Normbereich oder In-situ-Gebärmutterhalskrebs.

E.5 End points

E.5.1

Primary end point(s)

To evaluate efficacy in both treatment arms:
- Failure-Free Survival (FFS) at 30 months

Beurteilung der Wirksamkeit in beiden Behandlungsarmen:
- Eventfreies Überleben (FFS) nach 30 Monaten

E.5.1.1

Timepoint(s) of evaluation of this end point

Failure-Free Survival (FFS) at 30 months

Eventfreies Überleben (FFS) nach 30 Monaten

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

Failure-Free Survival (FFS) at 30 months

Eventfreies Überleben (FFS) nach 30 Monaten

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

Yes

E.8.1.1

Randomised

Yes

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

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

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

letzter Visit, letzter Patient

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 months

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:

100

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

100

F.4.2

For a multinational trial

F.4.2.1

In the EEA

150

F.4.2.2

In the whole clinical trial

150

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)

Any choice of subsequent treatment is up to the decision of the treating physician. Type/regimen used and response to subsequent treatment should be reported in the eCRF. Patients should be offered to take part in the registry of the European Mantle Cell Lymphoma network, in which subsequent treatment lines can be registered for better understanding of treatment, response and survival patterns.

Die Wahl der nachfolgenden Behandlung liegt im Ermessen des behandelnden Arztes. Art/Anwendung und Ansprechen auf die nachfolgende Behandlung sollten im eCRF angegeben werden. Den Patienten sollte angeboten werden, am Register des Europäischen Mantelzell-Lymphom-Netzes teilzunehmen, in dem nachfolgende Behandlungslinien zum besseren Verständnis von Behandlung, Ansprechen und Überleben registriert werden können.

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

2022-12-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-01-20

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

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