Clinical Trials Register

Summary
EudraCT Number:	2017-004232-11
Sponsor's Protocol Code Number:	M16-085
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:	2018-05-10
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

2017-004232-11

A.3

Full title of the trial

A Phase 2, Open-Label, Multicenter, Dose-Escalation and Expansion Study of Venetoclax in combination with Pomalidomide and Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma

Estudio en fase 2, multicéntrico, abierto y de incremento escalonado y ampliación de la dosis de venetoclax en combinación con pomalidomida y dexametasona en pacientes con mieloma múltiple recidivante o resistente

A.3.1

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

Open-Label, Multicenter, Dose-Escalation and Expansion Study of Venetoclax in Combination with Pomalidomide and Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma

Estudio de fase 2, en distintos centros, abierto, de escalado y expansión de dosis de venetoclax en compbinación con pomalidomida y dexametasona en pacientes con mieloma múltiple resistente o en recaída

A.4.1

Sponsor's protocol code number

M16-085

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	AbbVie Deutschland GmbH & Co. KG
B.1.3.4	Country	Germany
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	AbbVie 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	AbbVie Ltd.
B.5.2	Functional name of contact point	EU Clinical Trials Helpdesk
B.5.3	Address:
B.5.3.1	Street Address	AbbVie House, Vanwall Business Park, Vanwall Road
B.5.3.2	Town/ city	Maidenhead, Berkshire
B.5.3.3	Post code	SL6 4UB
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+34901200103
B.5.6	E-mail	abbvie_reec@abbvie.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	Yes
D.2.1.1.1	Trade name	Venclyxto
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	Yes
D.2.5.1	Orphan drug designation number	EU/3/16/1767
D.3 Description of the IMP
D.3.1	Product name	Venetoclax
D.3.2	Product code	ABT-199 (GDC-0199)
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.3.9.2	Current sponsor code	ABT-199 (GDC-0199)
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	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	Imnovid
D.2.1.1.2	Name of the Marketing Authorisation holder	Celgene Europe Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/09/672
D.3 Description of the IMP
D.3.1	Product name	Imnovid
D.3.2	Product code	pomalidomide
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	pomalidomide
D.3.9.1	CAS number	19171-19-8
D.3.9.3	Other descriptive name	POMALIDOMIDE
D.3.9.4	EV Substance Code	SUB33379
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	1
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: 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	Imnovid
D.2.1.1.2	Name of the Marketing Authorisation holder	Celgene Europe Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/09/672
D.3 Description of the IMP
D.3.1	Product name	Imnovid
D.3.2	Product code	pomalidomide
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	pomalidomide
D.3.9.1	CAS number	19171-19-8
D.3.9.3	Other descriptive name	POMALIDOMIDE
D.3.9.4	EV Substance Code	SUB33379
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	3
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: 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	Imnovid
D.2.1.1.2	Name of the Marketing Authorisation holder	Celgene Europe Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/09/672
D.3 Description of the IMP
D.3.1	Product name	Imnovid
D.3.2	Product code	pomalidomide
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	pomalidomide
D.3.9.1	CAS number	19171-19-8
D.3.9.3	Other descriptive name	POMALIDOMIDE
D.3.9.4	EV Substance Code	SUB33379
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	4
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

R/R Multiple Myeloma

Mieloma múltiple recidivante o resistente

E.1.1.1

Medical condition in easily understood language

Subjects with a type of blood cancer (multiple myeloma) that is either relapsed (comes back) or refractory (did not get better) after prior treatment.

Sujetos con un tipo de cáncer de sangre (mieloma múltiple) que es en recaída (la enfermedad ha vuelto) o resistente (que no tiene mejoras) después del primer tratamiento

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	10028228
E.1.2	Term	Multiple myeloma
E.1.2	System Organ Class	100000004864

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

To characterize the safety and tolerability profiles of venetoclax combined with pomalidomide and dexamethasone when co-administered in subjects with R/R MM

Para caracterizar los perfiles de seguridad y tolerabilidad de venetoclax en combinación con pomalidomida y dexametasona suministrados conjuntamente en sujetos con mieloma múltiple recidivante o resistente

E.2.2

Secondary objectives of the trial

-To evaluate the anti-MM activity of co-administered venetoclax combined with pomalidomide and dexamethasone when co-administered in subjects with R/R MM

-To characterize the plasma pharmaacokinetics (PK) of venetoclax and pomalidomide when co-administered in subjects with R/R MM

- Evaluar la activad anti mieloma múltiple de venetoclax en combinación con pomalidomida y dexametasona cuando suministrados conjuntamente en sujetos con mieloma múltiple recidivante o resistente
- Caracterizar la farmacocinética en plasma del venetoclax y pomalidomida cuando suministrados conjuntamente en sujetos con mieloma múltiple recidivante o resistente

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Male of female, at least 18 years old
• R/R MM with documented evidence of progression during or after the subject's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) criteria
• Measurable disease, defined by at least 1 of the following disease activity criteria:
- serum M-protein ≥ 1.0 g/dL (≥ 10 g/L) for immunoglobulin (Ig)G MM
- serum M-protein ≥ 0.5 g/dL (≥ 5 g/L) for IgA, IgD, IgE, and IgM MM
- urine M-protein ≥ 200 mg/24 hours
- serum-free light chain (FLC) ≥ 10 mg/dL provided serum FLC ratio is abnormal
• Has received at least 1 prior line of therapy
• Must meet all of the following prior antimyeloma treatment parameters:
- subject must have received at least 2 consecutive cycles of lenalidomide or a lenalidomide-containing regimen
- subject must be refractory to lenalidomide
- subject must have been exposed to a proteasome inhibitor alone or in combination with another agent
- subject must have had a response of PR or better to prior therapy based on the investigator's determination of response as defined by IMWG criteria
• Has t(11;14) status determined by an analytically validated fluorescent in situ hybridization (FISH) assay per central laboratory testing of a bone marrow aspirate sample and meets the following criteria:
- For Part 1: MM subjects independent of cytogenetic profile
- For Part 2, Arm A: subject must be t(11;14) positive
- For Part 2, Arm B: subject must be t(11;14) negative
• (ECOG) performance status ≤ 2

- Hombre o mujer, de al menos 18 años
- Mieloma múltiple recidivante o resistente con signos documentados de progresión durante o después de la última pauta de tratamiento del paciente según la determinación del investigador de los criterios del International Myeloma Working Group (IMWG).
- Enfermedad mensurable, definida por al menos 1 de los siguientes criterios de actividad de la enfermedad:
• Proteína M sérica ≥ 1,0 g/dl (≥ 10 g/l) para MM de inmunoglobulina (Ig)G.
• Proteína M sérica ≥ 0,5 g/dl (≥ 5 g/l) para MM IgA, IgD, IgE e IgM.
• Proteína M en orina ≥ 200 mg/24 horas.
• Cadenas ligeras libres (CLL) en suero ≥ 10 mg/dl (100 mg/l) siempre que el cociente de CLL en suero sea anómalo.
- Han recibido previamente al menos 1 línea de tratamiento.
- Deben cumplir todos los siguientes parámetros del tratamiento previo contra el mieloma:
• El paciente debe haber recibido al menos 2 ciclos consecutivos de lenalidomida o una pauta con lenalidomida.
• El paciente debe ser resistente a lenalidomida.
• El paciente debe haber estado expuesto a un inhibidor del proteasoma solo o en combinación con otro fármaco.
• El paciente debe haber tenido una respuesta de RP o mejor al tratamiento previo basándose en la determinación de la respuesta por el investigador según lo definido por los criterios del IMWG.
- El paciente tiene un estado t(11;14) determinado mediante un análisis de hibridación in situ con fluorescencia (FISH) validado analíticamente según el laboratorio central de una muestra de aspirado de médula ósea y cumple los criterios siguientes:
• En la parte 1: Pacientes con MM independientes del perfil citogenético.
• En la parte 2, grupo A: el paciente debe presentar positividad de t(11;14).
• En la parte 2, grupo B: el paciente debe presentar negatividad de t(11;14).
• Estado funcional del Eastern Cooperative Oncology Group (ECOG) ≤ 2.

E.4

Principal exclusion criteria

• previous treatment with venetoclax or other BCL-2 inhibitors, or previous treatment with pomalidomide
• known sensitivity to any IMiDs
• allogenic or syngeneic stem cell transplant within 6 months before the first dose of study drug or active ongoing graft versus host disease
• autologous stem cell transplant within 12 weeks before the first dose of study drug
• known meningeal involvement of MM

- tratamiento previo con venetoclax u otros inhibidores de BCL-2, o tratamientos previos con pomalidomida
- sensibilidad conocida a cualquier fármaco inmunomodulador
- transplante de células madre allogénico o singénico en los 6 meses antes de la primera dosis del medicamento del estudio o enfermedad activa de injerto en huesped
- transplante de células madre autólogo en las 12 semanas antes de la primera dosis del fármaco en estudio
- afectación meníngea conocida de mieloma múltiple

E.5 End points

E.5.1

Primary end point(s)

Overall Response Rate

Ratio de respuesta global

E.5.1.1

Timepoint(s) of evaluation of this end point

Dependent on individual subjects response to therapy. All subjects with be treated until progressive disease, unacceptable toxicity, or other reason for discontinuation

Dependiendo de la respuesta individual de cada sujeto a la terapia. Cada sujeto se tratará hasta la progresión de la enfermedad, toxicidad inaceptable, o cualquier otra razón para la discontinuación

E.5.2

Secondary end point(s)

- Secondary Endpoints are:
• Progression-free survival (PFS)
• Duration of response (DOR)
• Time-to-progression (TTP

Objetivos secundarios
- Supervivencia libre de progresión
- Duración de la respuesta
- Tiempo hasta la progresión

E.5.2.1

Timepoint(s) of evaluation of this end point

Will be monitored throughout the subject's participation in the study.

Se monitorizará a lo largo de la participación del sujeto en el 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

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

Yes

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

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

Spain

United Kingdom

United States

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

The end-of-study is defined as the last subject’s last visit, or date of the last follow-up contact, whichever is later.

El final del estudio está definido como la última visita del último sujeto o la fecha del último contacto de seguimiento, la que más tarde sea.

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

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

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)

For subjects that continue to derive benefit after 2 years of treatment following the date of the last subject enrolled, AbbVie will work with the investigator to evaluate options for continuation of venetoclax therapy.

Para los sujetos que continúan obteniendo beneficio 2 años después de tratamiento contando a partir de la fecha del último sujeto incluido, Abbvie trabajará con el Investigador para evaluar las opciones disponibles para continuar la terapia con Venetoclax.

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

2018-07-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-06-22

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-06-18

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