Clinical Trials Register

Summary
EudraCT Number:	2015-000287-34
Sponsor's Protocol Code Number:	ARO-012
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2017-01-05
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

Spain - AEMPS

A.2

EudraCT number

2015-000287-34

A.3

Full title of the trial

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Trial of Crenolanib in Subjects with Advanced or Metastatic Gastrointestinal Stromal Tumors with a D842V Mutation in the PDGFRA Gene.

Un estudio doble ciego multicéntrico y aleatorio controlado por placebo del uso de crenolanib en pacientes con tumores del estroma gastrointestinal avanzados o metastásicos con una mutación D842V en el gen PDGFRA

A.3.1

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

Study at several locations, randomized, double-blind with crenolanib in comparison with placebo in patients with advanced or metastatic gastrointestinal stromal tumors with a specific mutation (D842V) in the PDGFRA gene.

Un estudio en varios centros, aleatorio, doble ciego con crenolanib en comparación con placebo en pacientes con tumores del estroma gastrointestinal avanzados o metastásicos con una mutación (D842V) en el gen PDGFRA

A.4.1

Sponsor's protocol code number

ARO-012

A.5.4

Other Identifiers

Name:

IND Number

Number:

067968

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	Arog Pharmaceuticals, 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	Arog Pharmaceuticals, 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	Arog Pharmaceuticals, Inc.
B.5.2	Functional name of contact point	Clinical Trials Information
B.5.3	Address:
B.5.3.1	Street Address	5420 LBJ Freeway, Suite 410
B.5.3.2	Town/ city	Dallas, TX
B.5.3.3	Post code	75240
B.5.3.4	Country	United States
B.5.4	Telephone number	+34607 939 266
B.5.5	Fax number	+1214594 0002
B.5.6	E-mail	vjain@arogpharma.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	Crenolanib
D.3.2	Product code	AR-868,596-26
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	Crenolanib Besylate
D.3.9.1	CAS number	670220-93-6
D.3.9.2	Current sponsor code	AR-868,596-26
D.3.9.3	Other descriptive name	1-[2-[5-[(3-Methyl-3-oxetanyl)methoxy]-1H-benzimidazol-1-yl]-8-quinolinyl]-4-piperidinamine, monobenzenesulfonate
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	20
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	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	Crenolanib
D.3.2	Product code	AR-868,596-26
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	Crenolanib Besylate
D.3.9.1	CAS number	670220-93-6
D.3.9.2	Current sponsor code	AR-868,596-26
D.3.9.3	Other descriptive name	1-[2-[5-[(3-Methyl-3-oxetanyl)methoxy]-1H-benzimidazol-1-yl]-8-quinolinyl]-4-piperidinamine, monobenzenesulfonate
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Advanced or metastatic gastrointestinal stromal tumor (GIST)

Tumor del estroma gastrointestinal avanzado o metastásico

E.1.1.1

Medical condition in easily understood language

Tumor of the gastrointestinal tract

Tumor del tracto gastrointestinal

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	LLT
E.1.2	Classification code	10062427
E.1.2	Term	Gastrointestinal stromal tumor
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 compare the treatment effect of crenolanib with that of placebo on prolonging progression-free survival (PFS) in subjects with advanced or metastatic GIST with a PDGFRA D842V mutation.

Comparar el efecto del tratamiento con crenolanib con el efecto del placebo a la hora de prolongar la supervivencia libre de progresión (SLP) de pacientes con GIST avanzados o metastásicos con una mutación D842V en el gen PDGFRA.

E.2.2

Secondary objectives of the trial

To compare the treatment effect of crenolanib with that of placebo on overall survival (OS) and objective response rate (ORR).

Comparar el efecto del tratamiento con crenolanib con el efecto del placebo en lo relativo a la supervivencia global (SG) y a la tasa de respuesta objetiva (TRO).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Histologically or cytologically-confirmed advanced or metastatic GIST with a D842V mutation in the PDGFRA gene as determined by central laboratory testing
2. Measurable disease as per modified RECIST 1.1
- A lesion in an area that was previously treated with local therapy (e.g. radiation, surgery, or cryotherapy) can be considered measurable disease as long as there is objective evidence of progression of the lesion prior to randomization
3. Disease progression per modified RECIST 1.1 within 6 months of randomization
4. Subjects (male or female) ≥ 18 years of age
5. Adequate bone marrow function, defined as:
- ANC of ≥ 1000 /µL
- Platelet count of ≥ 75 x 10^9/L
6. Adequate hepatic function, defined as:
- Serum total bilirubin within normal limits
- Serum aspartate aminotransferase (AST) ≤ 2.0 x upper limit of normal (ULN)
- Serum alanine aminotransferase (ALT) ≤ 2.0 x ULN
7. Adequate renal function, defined as:
- Serum creatinine ≤ 1.5 x ULN or
- Creatinine clearance estimate of ≥ 50 mL/min (as calculated according to Cokcroft-Gault formula or MDRD formula for subjects > 65 years).
8. Female subjects with reproductive potential must have negative serum or urine pregnancy test
Female subjects who meet at least one of the following criteria are defined as women of non-reproductive potential:
- ≥50 years old and naturally amenorrheic for ≥ 1 year
- Permanent premature ovarian failure confirmed by a gynecologist
- Previous bilateral salpingo-oophorectomy
- XY genotype, Turner’s syndrome, or uterine agenesis
9. Prior treatment with imatinib, sunitinib, regorafenib, dasatinib and/or nilotinib is allowed. Recovered from prior treatment-related toxicity to Grade ≤ 2 per CTCAE v4.03 or the subject’s baseline preceding the prior treatment.
10. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
11. Adequate contraception:
- Female subjects with reproductive potential in combination with their partner must use 2 forms of highly effective methods of contraception during study treatment and for at least 30 days after ending treatment
- Male subjects in combination with their partner must use 2 forms of highly effective methods of contraception during study treatment and for at least 90 days after ending treatment
12. Written informed consent before any study-specific procedure is performed

1. GIST avanzado o metastásico confirmado por citología o histología con una mutación D842V en el gen PDGFRA determinado por las pruebas del laboratorio central
2. Enfermedad medible según los criterios RECIST 1.1 modificados (Apéndice V)
- Una lesión en una zona previamente tratada con terapias locales (como radioterapia, cirugía o crioterapia) puede ser considerada una enfermedad medible siempre que existan pruebas objetivas de la progresión de la lesión antes de la asignación al azar
3. Progresión de la enfermedad según los criterios RECIST 1.1 modificados en los seis meses posteriores a la asignación al azar
4. Pacientes (hombres o mujeres) con más de 18 años en la fecha de la firma del formulario de consentimiento informado
5. Función de la médula ósea adecuada, definida en función de los valores siguientes en sangre periférica:
- RAN de ≥ 1000 /µL
- Recuento de plaquetas de ≥ 75 x 109/L
6. Función hepática adecuada, definida como:
- Bilirrubina sérica total dentro de los límites normales de cada institución
- Aspartato aminotransferasa sérica (AST) ≤ 2,0 x límite superior de la normalidad (LSN)
- Alanina aminotransferasa sérica (ALT) ≤ 2,0 x LSN
7. Función renal adecuada, definida como:
- Creatinina sérica ≤ 1,5 x LSN o
- Estimación de la depuración de la creatinina ≥ 50 mL/min (calculada utilizando la fórmula Cokcroft-Gault o la fórmula MDRD para pacientes mayores de 65 años)
8. Las pacientes fértiles de sexo femenino deben realizarse una prueba de embarazo mediante un análisis de sangre o de orina, cuyo resultado debe ser negativo
Las pacientes que cumplan al menos uno de los criterios siguientes se definen como mujeres no fértiles:
- ≥ 50 años y con amenorrea natural durante ≥ 1 año
- Fallo ovárico prematuro permanente confirmado por un ginecólogo
- Salpingo-ooforectomía bilateral previa
- Genotipo XY, síndrome de Turner o agenesia uterina
9. Pueden participar en el estudio pacientes que hayan sido tratados anteriormente con imatinib, sunatinib, regorafenib, dasatinib y/o nilotinib. Paciente recuperado de una toxicidad previa relacionada con un tratamiento hasta Grado ≤ 2 según CTCAE v4.03 o la base de referencia del paciente antes del tratamiento anterior
10. Estado funcional según la escala del Grupo Oncológico Cooperativo del Este (ECOG) ≤ 2
11. Anticoncepción adecuada:
- Las pacientes fértiles de sexo femenino, junto con sus parejas, deben utilizar dos métodos anticonceptivos de elevada eficacia durante el tratamiento del estudio y al menos 30 días después de terminar el tratamiento
- Los pacientes de sexo masculino, junto con sus parejas, deben utilizar dos métodos anticonceptivos de elevada eficacia durante el tratamiento del estudio y al menos 90 días después de terminar el tratamiento
12. Firma del formulario de consentimiento informado antes de la realización de cualquier procedimiento específico del estudio

E.4

Principal exclusion criteria

1. Severe liver disease (e.g. cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis)
2. Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Active infection with HBV is defined as:
o Acute hepatitis B (diagnosed < 6 months prior to randomization), or
o Serologic test positive for HBV surface antigen (HBsAg) positive, or
o Serologic test positive for immunoglobulin (IgM) to HBV core antigen (IgM anti-HBc)
- Active infection with HCV is defined as:
o Acute hepatitis C (diagnosed < 6 months prior to randomization), or
o Positive for HCV ribonucleic acid (RNA)
Subjects with history of positive anti-HCV screening test (e.g. enzyme immune-assay [EIA], chemiluminescence immunoassay [CIA], or recombinant immunoblot assay [RIA]) should be tested for HCV RNA
3. History of other malignancy within the past 3 years, except:
- Malignancy treated with curative intent and with no evidence of disease and considered to be at low risk of recurrence by the treating physician
- Adequately treated non-melanoma skin cancer or lentigo maligna with no evidence of disease
- Adequately treated cervical carcinoma in situ with no evidence of disease
- Adequately treated breast ductal carcinoma in situ with no evidence of disease
- Adequately treated prostatic intraepithelial neoplasia with no evidence of disease
- Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ with no evidence of disease
4. Any disorder that compromises the subject’s ability to give written informed consent and/or to comply with study procedures
5. Any severe and/or uncontrolled medical or psychiatric conditions that in the opinion of the investigator, may prevent the subject from completing the study, interfere with the evaluation of safety and/or efficacy, or interfere with the interpretation of the study results
6. Female subject who is pregnant or breastfeeding, or planning to become pregnant within 30 days after ending treatment
7. Systemic anti-cancer treatment (e.g. chemotherapy, tyrosine kinase inhibitors, immunotherapy, or investigational agents) or investigational device within 3 weeks or 5 half-lives (if the drug’s halflife in subject is known) prior to randomization, whichever is shorter
8. Prior administration of crenolanib

1. Enfermedades hepáticas graves (como cirrosis, esteatohepatitis no alcohólica, colangitis esclerosante)
2. Infección activa conocida con virus de la hepatitis B (VHB) o de la hepatitis C (VHC)
- Una infección activa con VHB se define como:
o Hepatitis B aguda (diagnosticada < 6 meses antes de la asignación al azar), o
o Prueba serológica positiva para el antígeno de superficie del VHB (HBsAg), o
o Prueba serológica positiva para inmunoglobulina (IgM) contra el antígeno nuclear del VHB (IgM anti-HBc)
- Una infección activa con VHC se define como:
o Hepatitis C aguda (diagnosticada < 6 meses antes de la asignación al azar), o
o Positivo en ácido ribonucleico (ARN) del VHC
A los pacientes con antecedentes de pruebas de cribado antiVHC con resultado positivo (prueba inmunoenzimática [EIA], prueba por quimioluminiscencia [CIA] o prueba de inmunotransferencia recombinante [RIA]) debería hacérseles una prueba de ARN del VHC
3. Antecedentes de otros tumores malignos en los últimos 3 años, excepto:
- Tumores malignos tratados con intención curativa y sin evidencias de enfermedad que el médico del tratamiento considere que tienen un bajo riesgo de recurrencia
- Cáncer de piel no melanoma o léntigo maligno tratado adecuadamente sin evidencias de enfermedad
- Carcinoma cervical in situ tratado adecuadamente sin evidencias de enfermedad
- Carcinoma ductal de mama in situ tratado adecuadamente sin evidencias de enfermedad
- Neoplasia intraepitelial prostática tratada adecuadamente sin evidencias de enfermedad
- Carcinoma urotelial papilar no invasivo o carcinoma in situ tratado adecuadamente sin evidencias de enfermedad
4. Cualquier enfermedad que impida al paciente proporcionar su consentimiento informado por escrito y/o seguir los procedimientos del estudio
5. Cualquier enfermedad médica o psiquiátrica grave y/o no controlada que, según el criterio del investigador, pudiera impedir al paciente completar el estudio, interferir en la evaluación de su seguridad y/o eficacia o interferir en la interpretación de los resultados del estudio
6. Pacientes de sexo femenino que estén embarazadas o amamantando o que tengan previsto quedarse embarazadas antes de que pasen 30 días desde la finalización del tratamiento
7. Tratamiento sistémico del cáncer (quimioterapia, inhibidores de la tirosina quinasa, inmunoterapia o agentes experimentales) o dispositivo experimental en las 3 semanas o 5 semividas (si se conoce el tiempo de semivida del medicamento en el paciente) previas a la asignación al azar, el periodo que sea menor
8. Administración previa de crenolanib

E.5 End points

E.5.1

Primary end point(s)

Progression-free survival (PFS)

Supervivencia libre de progresión (SLP)

E.5.1.1

Timepoint(s) of evaluation of this end point

35 months

35 meses

E.5.2

Secondary end point(s)

- Overall survival
- Objective response rate (based on modified RECIST 1.1)

- Supervivencia global (SG)
- Tasa de respuesta objetiva (TRO; en base a los criterios RECIST 1.1 modificados)

E.5.2.1

Timepoint(s) of evaluation of this end point

35 months

35 meses

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

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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)

E.8.2.2

Placebo

Yes

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

France

Germany

Italy

Norway

Poland

Spain

Switzerland

United Kingdom

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

sujeto último visita última

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

120

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 finishing all study relevant procedures, therapy and follow-up period, the patient will be followed in terms of routine aftercare and treated if necessary by the primary responsible hematology/oncology center.

Después de terminar todos los procedimientos pertinentes del estudio, la terapia y el período de seguimiento, el paciente será seguido en términos de cuidado posterior de rutina y será tratado si necesario por el responsable primario del centro de hematología / oncología.

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

2017-02-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-02-10

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

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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