Clinical Trials Register

Summary
EudraCT Number:	2016-002980-33
Sponsor's Protocol Code Number:	BGB-3111-302
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-12-09
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

Spain - AEMPS

A.2

EudraCT number

2016-002980-33

A.3

Full title of the trial

A Phase 3, Randomized, Open-Label, Multicenter Study
Comparing the Efficacy and Safety of the Bruton’s Tyrosine
Kinase (BTK) Inhibitors BGB-3111 and Ibrutinib in Subjects
with Waldenström’s Macroglobulinemia (WM)

Estudio de Fase 3, abierto, aleatorizado y multicéntrico, para comparar la eficacia y la seguridad de BGB-3111 frente al ibrutinib, dos inhibidores de la tirosina cinasa de Bruton (BTK), en sujetos con macroglobulinemia de Waldenström (WM)

A.3.1

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

A Phase 3, Randomized, Open-Label, Multicenter Study Comparing the Efficacy and Safety of the medications BGB-3111 and Ibrutinib in Subjects with Waldenström’s Macroglobulinemia (WM)

Estudio de Fase 3, abierto, aleatorizado y multicéntrico, para comparar la eficacia y la seguridad de BGB-3111 frente al ibrutinib, en sujetos con macroglobulinemia de Waldenström (WM)

A.4.1

Sponsor's protocol code number

BGB-3111-302

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	BeiGene USA, Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	BeiGene USA, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	BeiGene USA, Inc.
B.5.2	Functional name of contact point	BeiGene Clinical Support
B.5.3	Address:
B.5.3.1	Street Address	USA
B.5.3.2	Town/ city	USA
B.5.3.3	Post code	USA
B.5.3.4	Country	United States
B.5.4	Telephone number	+3491 3913443
B.5.6	E-mail	BeigeneClinicalSupportUS@beigene.com

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	No
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	BGB-3111
D.3.2	Product code	BGB-3111
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	not yet established
D.3.9.1	CAS number	1691249-45-2
D.3.9.2	Current sponsor code	BGB-3111
D.3.9.3	Other descriptive name	PH-BEI-BGB-3111
D.3.9.4	EV Substance Code	SUB184615
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	80
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	Comparator
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
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	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	ibrutinib
D.3.9.1	CAS number	936563-96-1
D.3.9.3	Other descriptive name	IBRUTINIB
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	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

Subjects with Waldenström’s Macroglobulinemia (WM) who require therapy according to the consensus panel criteria from the 7th International Workshop on Waldenström’s Macroglobulinemia

Sujetos con macroglobulinemia de Waldenström (WM) que precisan tratamiento según los criterios del grupo de consenso del Séptimo Taller Internacional sobre Macroglobulinemia de Waldenström

E.1.1.1

Medical condition in easily understood language

Patients with Waldenström’s Macroglobulinemia (WM)

Pacientes con macroglobulinemia de Waldenström (WM)

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	19.0
E.1.2	Level	PT
E.1.2	Classification code	10047801
E.1.2	Term	Waldenstrom's macroglobulinaemia
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 evaluate the efficacy of BGB-3111 vs ibrutinib in subjects with MYD88MUT WM

Evaluar la eficacia del BGB-3111 frente al ibrutinib en sujetos con WM - MYD88MUT

E.2.2

Secondary objectives of the trial

To further evaluate the efficacy, clinical benefit, and anti-lymphoma effects of BGB-3111 vs ibrutinib in subjects with MYD88MUT WM.

To evaluate safety and tolerability of BGB-3111 versus ibrutinib in subjects with MYD88MUT WM, as measured by the incidence and severity of adverse events

Evaluar adicionalmente la eficacia, el beneficio clínico y los efectos antilinfoma del BGB-3111 frente al ibrutinib en sujetos con WM - MYD88MUT.

Evaluar la seguridad y la tolerabilidad del BGB-311 frente al ibrutinib en sujetos con WM - MYD88MUT, a juzgar por la incidencia y la intensidad de los acontecimientos adversos.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Clinical and definitive histologic diagnosis of WM
2. Meeting at least one criterion for treatment according to consensus panel criteria from the Seventh International Workshop on Waldenström’s macroglobulinemia (Dimopoulos et al 2014)
3. For subjects who have received no prior therapy for WM, they must be considered inappropriate candidates for treatment with a standard chemoimmunotherapy regimen
4. Measurable disease, as defined by serum IgM level >0.5 g/dL
5. Age ≥ 18 years old
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
7. Adequate bone marrow function defined as:
- Neutrophils ≥ 0.75 x 10 power 9/L independent of growth factor support within 7 days of study entry
- Platelets ≥ 50 x 10 power 9/L, independent of growth factor support or transfusion within 7 days of study entry
8. Creatinine clearance of ≥ 30 ml/min (as estimated by the Cockcroft-Gault equation or estimated glomerular filtration rate [eGFR] from the Modification of Diet in Renal Disease [MDRD])
13. Subjects may be enrolled who relapse after autologous stem cell transplant if they are at least 3 months after transplant, and after allogeneic transplant if they are at least 6 months posttransplant. To be eligible after either type of transplant, subjects should have no active
related infections or in the case of allogeneic transplant relapse, no active acute graft versus host disease (GvHD) of any grade, and no chronic GvHD other than mild skin, oral, or ocular GvHD not requiring systemic immunosuppression.

1. Diagnóstico clínico e histológico claro de WM
2. Cumplimiento de al menos uno de los criterios de tratamiento según los criterios del grupo de consenso del Séptimo IWWM (Dimopoulos et al 2014)
3. Si el sujeto no ha recibido tratamiento previo para la WM, se deberá considerar que no es un candidato adecuado para el tratamiento con un régimen de quimioinmunoterapia estándar
4. Enfermedad medible, definida por una concentración sérica de
IgM >0,5 g/dl
5. Edad >=18 años
6. Estado funcional del Eastern Cooperative Oncology Group (ECOG) de 0-2
7. Funcionalidad adecuada de la médula ósea, definida por:
- Neutrófilos >=0,75 × 109/l, con o sin tratamiento con factores de crecimiento, en un plazo de 7 días respecto a la entrada en el estudio
- Plaquetas >= 50 x 109/l, con o sin tratamiento con factores de crecimiento o transfusiones en un plazo de 7 días respecto a la entrada en el estudio
8. Aclaramiento de creatinina >=30 ml/min (según la ecuación de Cockcroft-Gault o la tasa de filtración glomerular estimada [eGFR, estimated glomerular filtration rate] con la fórmula Modification of Diet in Renal Disease [MDRD])
13. Se podrá incluir en el estudio a los sujetos con recidiva después de un trasplante de células madre si han transcurrido desde entonces al menos 3 meses en caso de autotrasplante o al menos 6 meses en caso de alotrasplante. Para poder participar en el estudio tras cualquiera de estos tipos de trasplante, el sujeto no deberá presentar infecciones activas o, en caso de recidiva tras un alotrasplante, no deberá presentar «enfermedad de injerto contra huésped» (GvHD, graft versus host disease) aguda activa de ningún grado ni crónica, excepto que esta última sea de carácter leve y localización cutánea, oral u ocular y que no precise inmunosupresión sistémica

E.4

Principal exclusion criteria

1. Prior exposure to a BTK inhibitor.
2. Evidence of disease transformation at the time of study entry.
3. Corticosteroids given with anti-neoplastic intent within 7 days, or chemotherapy, targeted therapy, or radiation therapy within 3 weeks, or antibody-based therapy within 4 weeks of the start of study drug.
4. Major surgery within 4 weeks of study treatment.
5. Toxicity of ≥ Grade 2 from prior anticancer therapy (except for alopecia, absolute neutrophil count [ANC] and platelets). For ANC and platelets, please follow inclusion criteria #7 [neutrophils] and [platelets]).
6. History of other active malignancies within 2 years of study entry, with exception of (1) adequately treated in-situ carcinoma of cervix; (2) localized basal cell or squamous cell carcinoma of skin; (3) previous malignancy confined and treated locally (surgery or other modality) with curative intent.
7. Currently active, clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, any Class 3 or 4 cardiac disease as defined by the New York Heart Association (NYHA) Functional Classification, or history of myocardial infarction within 6 months of screening.
8. QTcF prolongation (defined as a QTcF > 450 msec)
9. Active, clinically significant Electrocardiogram (ECG) abnormalities including second degree atrioventricular (AV) block Type II, or third degree AV block.
10. Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
11. Uncontrolled active systemic infection or recent infection requiring parenteral anti-microbial therapy that was completed ≤14 days before the first dose of study drug.
12. Known human immunodeficiency virus (HIV), or active hepatitis B (eg, hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (eg, hepatitis C virus [HCV] ribonucleic acid [RNA] detected).

1. Exposición previa a inhibidores de la tirosina-cinasa de Bruton
2. Indicios de transformación de la enfermedad en el momento de entrar en el estudio
3. Corticosteroides administrados con intención antineoplásica en un plazo de 7 días, o quimioterapia administrada con intención antineoplásica, terapia dirigida o radioterapia previas en un plazo de 3 semanas, o tratamiento con anticuerpos en un plazo de 4 semanas respecto al comienzo del fármaco del estudio
4. Cirugía mayor en un plazo de 4 semanas respecto al tratamiento del estudio.
5. Toxicidad de grado >=2 debida al tratamiento antineoplásico anterior (excepto en cuanto a alopecia, la cifra absoluta de neutrófilos y la cifra de plaquetas; para estos dos últimos casos deberá seguirse el criterio de inclusión n.º 7
6. Antecedentes de otras neoplasias malignas activas en un plazo de 2 años respecto a la entrada en el estudio, excepto (1) carcinoma de cuello uterino in situ tratado adecuadamente; (2) carcinoma cutáneo basocelular o espinocelular localizado; (3) neoplasia maligna previa confinada y tratada localmente (con cirugía u otro tratamiento) con intención curativa
7. Enfermedad cardiovascular de importancia clínica, actualmente activa, como arritmia no controlada, insuficiencia cardiaca congestiva, cualquier cardiopatía de clase 3 o 4 según la Clasificación Funcional de la New York Heart Association (NYHA), o antecedentes de infarto de miocardio en un plazo de 6 meses respecto a la selección
8. Prolongación del QTcF (definido como QTcF >450 ms)
9. Alteraciones electrocardiográficas activas de importancia clínica, como bloqueo auriculoventricular (AV) de segundo grado de tipo II o de tercer grado
10. Incapacidad para ingerir cápsulas o enfermedad que altere de manera importante la función gastrointestinal, como síndrome de malabsorción, resección gástrica o de intestino delgado, enfermedad inflamatoria intestinal sintomática u obstrucción intestinal parcial o completa
11.Infección sistémica activa no controlada o infección reciente que haya precisado antibioterapia parenteral y esta haya finalizado <=14 días antes de la primera dosis del fármaco del estudio
12.Infección conocida por el virus de la inmunodeficiencia humana (HIV, human immunodeficiency virus) o infección activa por los virus de la hepatitis B (por ejemplo, reactividad del antígeno de superficie del virus de la hepatitis B [HBsAg]) o de la hepatitis C (por ejemplo, detección del ácido ribonucleico [RNA] del virus de la hepatitis C [HCV]).

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is the proportion of subjects in Cohort 1 achieving either CR or VGPR, as determined by independent review committee (IRC) using an adaptation of the response criteria updated at the Sixth IWWM (Owen et al. 2013 and NCCN Guidelines, Lymphoplasmacytic
Lymphoma/Waldenström’s Macroglobulinemia 2015: v2).

El criterio principal de valoración es el porcentaje de sujetos en
Cohorte 1 que alcancen una respuesta completa o una respuesta parcial muy buena (VGPR, very good partial response) en su determinación por el IRC según una adaptación de los criterios de respuesta actualizados en el Sexto IWWM (Owen et al. 2013 y NCCN Guidelines, Lymphoplasmacytic Lymphoma/Waldenström’s Macroglobulinemia 2015:v2)

E.5.1.1

Timepoint(s) of evaluation of this end point

As determined by independent review committee (IRC).

A determinar por el comité de revisión independiente (IRC)

E.5.2

Secondary end point(s)

- Major response rate (MRR) as assessed by the IRC, defined as the proportion of subjects achieving a best response of response of CR, VGPR, or partial response (PR) at any time during the course of study treatment
- Duration of response (DOR) as assessed by the IRC, defined as the time from first determination of response (CR, VGPR or PR) (per modified IWWM criteria) until first documentation of progression (per modified IWWM criteria) or death, whichever comes first
- Rate of CR or VGPR as assessed by the Investigator
- DOR as assessed by the Investigator, defined as the time from first determination of response (CR, VGPR or of PR) (per modified IWWM criteria) until first documentation of progression (per modified IWWM criteria) or death, whichever comes first
- Progression-free survival (PFS) as assessed by the IRC, defined as time from randomization to the first documentation of progression (per modified IWWM criteria) or death, whichever occurs first
- PFS as assessed by the Investigator, defined as time from randomization to the first documentation of progression (per modified IWWM criteria) or death, whichever occurs first
- Resolution of treatment-precipitating symptoms, defined as the absence of the symptoms that triggered initiation of study treatment (per the IWWM treatment guidelines) at any point during study treatment

- Anti-lymphoma effect, defined as any reduction in bone marrow involvement by lymphoplasmacytoid lymphocytes and/or size of lymphadenopathy and/or hepatosplenomegaly by CT scan, at any time during the course of study treatment

- Tasa de respuesta mayor (MRR, major response rate) en su evaluación por el IRC, que se define como el porcentaje de sujetos que alcanzan como mejor respuesta una respuesta completa, una respuesta parcial muy buena o una respuesta parcial (PR, partial response) en algún momento en el transcurso del tratamiento del estudio
- Duración de la respuesta (DOR, duration of response) en su evaluación por el IRC, que se define como el tiempo que transcurre desde la primera determinación de la respuesta (respuesta completa, respuesta parcial muy buena o respuesta parcial) (según los criterios modificados del IWWM) hasta la primera vez que se documenta la progresión (según los criterios modificados del IWWM) o la muerte, lo que antes suceda
- Tasa de respuesta completa o respuesta parcial muy buena en su evaluación por el investigador
- Duración de la respuesta en su evaluación por el investigador, que se define como el tiempo que transcurre desde la primera determinación de la respuesta (respuesta completa, respuesta parcial muy buena o respuesta parcial) (según los criterios modificados del IWWM) hasta la primera vez que se documenta la progresión (según los criterios modificados del IWWM) o la muerte, lo que antes suceda
- Supervivencia sin progresión (PFS, progression-free survival) en su evaluación por el IRC, que se define como el tiempo que transcurre entre la aleatorización y la primera vez que se documenta la progresión (según los criterios modificados del IWWM) o la muerte, lo que antes suceda
- Supervivencia sin progresión en su evaluación por el investigador, que se define como el tiempo que transcurre entre la aleatorización y la primera vez que se documenta la progresión (según los criterios modificados del IWWM) o la muerte, lo que antes suceda
- Resolución de los síntomas que desencadenaron el tratamiento, lo que se define como la ausencia de los síntomas que hubieran motivado el comienzo del tratamiento del estudio (según las directrices de tratamiento del IWWM) en algún momento durante el tratamiento del estudio
- Efecto antilinfoma, que se define como toda reducción de la infiltración de la médula ósea por linfocitos linfoplasmocitoides y/o el tamaño de las linfadenopatías y/o la hepatoesplenomegalia en un examen por tomografía computarizada en cualquier momento durante el transcurso del tratamiento del estudio

E.5.2.1

Timepoint(s) of evaluation of this end point

Major response rate (MRR):
As assessed by the Independent Review Committee (IRC).

Duration of Response (DOR):
As assessed by the investigator or the IRC.

Rate of CR or VGPR:
Complete Response (CR): every 24 weeks, at time of suspected complete response (CR), and as clinically indicated.
Very good partial response (VGPR): as assessed by the investigator.

Progression Free Survival:
As assessed by the investigator or the IRC.

Anti-lymphoma effect:
At any time during the course of the study.

Tasa de respuesta mayor (MRR):
A evaluar por el comité de revisión independiente (IRC)

Duración de Respuesta (DOR)
A evaluar por el investigador o el IRC

Tasa de CR o VGPR
Respuesta complete (CR): cada 24 semanas, en el momento de sospecha de respuesta completa (CR).
Respuesta parcial muy buena (VGPR): en su evaluación por el investigador.

Supervivencia Sin Progrésión:
A evaluar por el investigador o el IRC

Efecto antilinfoma
Durante el transcurso del tratamiento del estudio

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

Yes

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

Yes

E.6.13.1

Other scope of the trial description

To explore mechanisms of disease resistance in samples from subjects with WM who fail to respond, and from those who manifest disease relapse.

Explorar los mecanismos de resistencia de la enfermedad en muestra de sujetos con WM que no han respondido y de aquellos que manifiesten recaída en la enfermedad.

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

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

Yes

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Belgium

France

Germany

Greece

Italy

Netherlands

Poland

Spain

Sweden

United Kingdom

United States

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

Subjects will receive daily treatment during the study until disease progression
(PD), unacceptable toxicity or death, withdrawal of consent, loss to follow-up,
or study termination by Sponsor.

Los sujetos recibiran tratamiento diario durante el estudio hasta progression de la enfermedad (PD), toxicidad inaceptable o muerte, abandono de consentimiento, perdida de seguimiento o terminación del estudio por parte del promotor.

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:

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

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

167

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)

After 3 years, the formal end of the study treatment, patients who were randomised to BGB-3111 will be eligible for continued treatment on a separate extension study. Patients who had been randomised to the ibrutinib arm will not receive therapy on study, but may be transferred to commercially available drug if available or other therapy as per investigator's medical judgement.

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

2017-02-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-01-26

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-06-21

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