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Summary
EudraCT Number:2022-000380-46
Sponsor's Protocol Code Number:75276617ALE1003
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:2023-01-09
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
A. Protocol Information
A.1Member State ConcernedSpain - AEMPS
A.2EudraCT number2022-000380-46
A.3Full title of the trial
A Phase I/Ib Study of JNJ-75276617 in Combination with Conventional Chemotherapy for Pediatric and Young Adult Participants with Relapsed/Refractory Acute Leukemias Harboring KMT2A, NPM1, or Nucleoporin Gene Alterations
Estudio fase I/Ib de administración de JNJ-75276617 en combinación con quimioterapia convencional para sujetos pediátricos y adultos jóvenes con leucemias agudas en recaída o refractarias que presentan alteraciones genéticas en KMT2A, NPM1 o nucleoporina
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
A Phase I/Ib Study of JNJ-75276617 in Pediatric and Young Adult Participants with Relapsed/Refractory Acute Leukemias
Estudio fase I/Ib de JNJ-75276617 en sujetos pediátricos y adultos jóvenes con leucemias agudas en recaída o refractarias
A.3.2Name or abbreviated title of the trial where available
Phase I/Ib Study in Pediatric and Young Adult Participants with Relapsed/Refractory Acute Leukemias
Estudio fase I/Ib en sujetos pediátricos y jóvenes con Leucemias Agudas en recaída/refractarias
A.4.1Sponsor's protocol code number75276617ALE1003
A.7Trial is part of a Paediatric Investigation Plan No
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorJanssen-Cilag International NV
B.1.3.4CountryBelgium
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing supportJanssen Research & Development, LLC
B.4.2CountryUnited States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationJanssen-Cilag International NV
B.5.2Functional name of contact pointGlobal Clinical Operations Spain
B.5.3 Address:
B.5.3.1Street AddressPaseo de las Doce Estrellas, 5-7
B.5.3.2Town/ cityMadrid
B.5.3.3Post code28042
B.5.3.4CountrySpain
B.5.4Telephone number+34647364160
B.5.5Fax number+3491 7228628
B.5.6E-mailacalaver@its.jnj.com
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameJNJ-75276617
D.3.4Pharmaceutical form Powder for oral solution
D.3.4.1Specific paediatric formulation Yes
D.3.7Routes of administration for this IMPOral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNJNJ-75276617
D.3.9.2Current sponsor codeJNJ-75276617
D.3.9.3Other descriptive nameJNJ-75276617
D.3.9.4EV Substance CodeSUB221179
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number5
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 2
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameJNJ-75276617
D.3.4Pharmaceutical form Powder for oral solution
D.3.4.1Specific paediatric formulation Yes
D.3.7Routes of administration for this IMPOral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNJNJ-75276617
D.3.9.2Current sponsor codeJNJ-75276617
D.3.9.3Other descriptive nameJNJ-75276617
D.3.9.4EV Substance CodeSUB221179
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number20
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another 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.1.1Medical condition(s) being investigated
Relapsed/Refractory Acute Leukemias Harboring KMT2A, NPM1, or Nucleoporin Gene Alterations
Leucemias agudas en recaída/refractarias que albergan alteraciones genéticas de KMT2A, NPM1 o nucleoporina
E.1.1.1Medical condition in easily understood language
Relapsed/Refractory Acute Leukemias
Leucemias agudas en recaída/refractarias
E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 21.0
E.1.2Level LLT
E.1.2Classification code 10000844
E.1.2Term Acute lymphoblastic leukaemia
E.1.2System Organ Class 100000004864
E.1.2 Medical condition or disease under investigation
E.1.2Version 21.0
E.1.2Level LLT
E.1.2Classification code 10060354
E.1.2Term Acute myeloblastic leukaemia
E.1.2System Organ Class 100000004864
E.1.2 Medical condition or disease under investigation
E.1.2Version 21.0
E.1.2Level LLT
E.1.2Classification code 10000833
E.1.2Term Acute leukaemia of unspecified cell type
E.1.2System Organ Class 100000004864
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
1. Part 1 (dose escalation): To determine the recommended Phase 2 dose(s) (RP2Ds) of JNJ-75276617 in combination with chemotherapy in pediatric and young adult participants with relapsed/refractory acute leukemia harboring KMT2A1, NPM1, or nucleoporin alterations.

2. Part 2 (dose expansion): To further evaluate safety at the RP2D(s) of JNJ-75276617 in combination with chemotherapy in pediatric and young adult participants with relapsed/refractory acute leukemia harboring KMT2A1, NPM1, or nucleoporin alterations and safety at the RP2D(s) of JNJ-75276617 as monotherapy in a select low burden of disease cohort.
1. Parte 1 (aumento escalonado de la dosis): determinar la(s) dosis recomendada(s) para la fase 2 (DRF2) de JNJ-75276617 en combinación con quimioterapia convencional en sujetos pediátricos y adultos jóvenes con leucemia aguda en recaída o refractaria que presentan alteraciones de KMT2A1, NPM1 o nucleoporina.

2. Parte 2 (ampliación de la dosis): evaluar la seguridad de JNJ-75276617 en la DRF2 en combinación con quimioterapia en sujetos pediátricos y adultos jóvenes con leucemia aguda en recaída o refractaria que presentan alteraciones de KMT2A1, NPM1 o nucleoporina, así como evaluar la seguridad de JNJ-75276617 en la DRF2 como monoterapia en una cohorte seleccionada con baja carga de enfermedad.
E.2.2Secondary objectives of the trial
1. Assess the pharmacokinetics of JNJ-75276617.
2. Assess the pharmacodynamics of JNJ-75276617.
3. Assess the preliminary efficacy of JNJ-75276617 when administered at the RP2D
1. Evaluar la farmacocinética de JNJ-75276617.
2. Evaluar la farmacodinamia de JNJ-75276617.
3. Evaluar la eficacia preliminar de JNJ-75276617 cuando se administra a la DRF2.
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
1. Participants must be ≥30 days and ≤30 years of age.

2. Acute leukemia harboring KMT2A or NPM1 or nucleoporin (NUP98 or NUP214) alterations.

3. B-cell ALL or AML as defined by the criteria below:
- Must have ≥5% leukemic blasts in the bone marrow or presence of leukemic blasts in the peripheral blood
- EXCEPTION: For dose expansion Cohort 3 only, participants with <5% blasts in the bone marrow will be eligible if they have clinical documentation of relapse.
- Participants with acute leukemia of ambiguous lineage, mixed phenotypic acute leukemia, or undifferentiated leukemia may be considered for the study if they harbor a KMT2A, NPM1, NUP98, or NUP214 alteration. In these cases, the site Investigator upon discussion with Sponsor must agree to adhere to either the B-cell ALL or AML chemotherapy backbone and provide justification for the choice, which may include but is not limited to the immunophenotype based on flow cytometry, prior therapy, and patient-specific data.

4. Treatment exposure to prior systemic therapy must include
For ALL:
- Relapsed or refractory following at least two lines of therapy, including after hematopoietic stem cell transplantation (HSCT)
- For participants with Philadelphia chromosome (Ph+) ALL: Disease must be resistant or intolerant to all available tyrosine kinase inhibitors
For AML:
- Refractory to at least two induction regimens OR
- Disease present in first or subsequent relapse, including after hematopoietic stem cell transplantation (HSCT)
For acute leukemia of ambiguous lineage, mixed phenotypic acute leukemia, or undifferentiated leukemia:
- Refractory to at least two induction regimens OR
- Refractory to one prior induction/consolidation regimen OR
- Disease present in first or subsequent relapse, including after hematopoietic stem cell transplantation (HSCT)

5. Performance status ≥50 by Lansky scale (for subjects <16 years of age) or ≥50% Karnofsky scale (for subjects ≥16 years of age).
1. Los pacientes deben tener ≥30 días y ≤30 años.

2. Leucemia aguda con alteraciones en KMT2A, NPM1 o nucleoporina (NUP98 o NUP214).

3. LLA de linfocitos B o LMA según los criterios que se indican a continuación:
- Deben tener ≥5 % de blastos leucémicos en la médula ósea o presencia de blastos leucémicos en la sangre periférica
- EXCEPCIÓN: Solo para la cohorte 3 de ampliación de dosis, los pacientes con <5 % de blastos en la médula ósea serán elegibles si tienen documentación clínica de recaída.
- Los pacientes con leucemia aguda de linaje ambiguo, leucemia aguda de fenotipo mixto o leucemia no diferenciada se pueden considerar para el estudio si presentan una alteración en KMT2A, NPM1, NUP98 o NUP214. En estos casos, el investigador del centro, tras discutirlo con el sponsor, debe estar de acuerdo en adherirse a la quimioterapia convencional para la LLA de linfocitos B o la LMA y proporcionar una justificación de su elección, que puede incluir, entre otros, el inmunofenotipo basado en la citometría de flujo, el tratamiento previo y los datos específicos del paciente.

4. La exposición a un tratamiento sistémico previo debe incluir:
Para la LLA:
- Enfermedad en recaída o refractaria tras al menos dos líneas de tratamiento, incluso después de un trasplante de células madre hematopoyéticas (TCMH)
- Para pacientes con LLA con el cromosoma Filadelfia (Ph+): la enfermedad debe ser resistente o intolerante a todos los inhibidores de la tirosina quinasa disponibles
Para la LMA:
- Enfermedad refractaria al menos a dos pautas de inducción Ó
- Enfermedad presente en la primera o posterior recaída, incluso después de un trasplante de células madre hematopoyéticas (TCMH)
Para la leucemia aguda de linaje ambiguo, la leucemia aguda de fenotipo mixto o la leucemia no diferenciada:
- Enfermedad refractaria al menos a dos pautas de inducción Ó
- Enfermedad refractaria a una pauta previa de inducción/consolidación Ó
- Enfermedad presente en la primera o posterior recaída, incluso después de un trasplante de células madre hematopoyéticas (TCMH)

5. Estado funcional ≥50 según la escala de Lansky (para pacientes <16 años) o ≥50 % según la escala de Karnofsky (para pacientes ≥16 años)
E.4Principal exclusion criteria
1. Received an allogeneic hematopoietic transplant within 60 days of screening.

2. Has isolated extramedullary disease.

3. Active acute graft-versus-host disease of any grade or chronic graft versus host which is not well-controlled.

4. Received immunosuppressive therapy post hematopoietic transplant within 30 days of enrollment.

5. Diagnosis of Down syndrome associated leukemia, acute promyelocytic leukemia, juvenile myelomonocytic leukemia.
1. Haber recibido un transplante alogénico de células hematopoyéticas en los 60 días previos a la selección.

2. Tener una enfermedad extramedular aislada.

3. Enfermedad aguda de injerto contra huésped activa de cualquier grado o enfermedad crónica de injerto contra huésped que no esté bien controlada.

4. Haber recibido un tratamiento inmunosupresor tras un trasplante de células hematopoyéticas en los 30 días anteriores al reclutamiento.

5. Diagnóstico de leucemia asociada al síndrome de Down, leucemia promielocítica aguda o leucemia mielomonocítica juvenil.
E.5 End points
E.5.1Primary end point(s)
1. Incidence and severity of AEs, including dose-limiting toxicity (DLT).
2. Incidence and severity of AEs.
1. Incidencia y gravedad de los AA, incluida la toxicidad limitante de dosis (TLD)
2. Incidencia y gravedad de los AA
E.5.1.1Timepoint(s) of evaluation of this end point
From the signing of ICF to up to 30 days after the last dose of study treatment or until the start of the first subsequent anticancer therapy, if earlier.
Desde la firma del DCI hasta 30 días después de la última dosis del tratamiento del estudio o hasta el inicio de la primera terapia anticancerígena posterior, si es anterior.
E.5.2Secondary end point(s)
1. Plasma concentration-time profiles and pharmacokinetic parameters for JNJ-75276617
2. Pharmacodynamic markers including but not limited to depletion and/or differentiation of leukemic blasts, changes in expression of HOXA9, MEIS1, other menin-KMT2A target genes or genes associated with differentiation.
3. Overall response achieving a complete response (CR) + CR with incomplete hematologic recovery (CRi) + CR with partial hematologic recovery (CRh) per the Response Criteria in AML as outlined in ELN 2017.
4. Overall response achieving a complete response (CR) + CR with incomplete hematologic recovery (CRi) per the Response Criteria in B-cell ALL based on modified National Comprehensive Cancer Network (NCCN) criteria.
5. Time to Response
6. Duration of Response
7. Allogeneic HSCT rate: The proportion of subjects who received an allogeneic HSCT after treatment.
1. Perfiles de concentración plasmática frente a tiempo y parámetros farmacocinéticos de JNJ-75276617
2. Marcadores farmacodinámicos que incluyen, entre otros, la reducción o diferenciación de los blastos leucémicos, cambios en la expresión de HOXA9, MEIS1, otros genes diana menina-KMT2A o genes asociados a la diferenciación.
3. Respuesta global que logre una respuesta completa (RC) + RC con recuperación hematológica incompleta (RCi) + RC con recuperación hematológica parcial (RCh) según los criterios de respuesta en la LMA recogidos en ELN 2017
4. Respuesta global que logre una respuesta completa (RC) + RC con recuperación hematológica incompleta (RCi) según los criterios de respuesta en la LLA de linfocitos B basados en los criterios modificados de la National Comprehensive Cancer Network (NCCN)
5. Tiempo hasta la respuesta
6. Duración de la respuesta
7. Tasa de TCMH alogénico: la proporción de pacientes que recibieron un TCMH alogénico después del tratamiento
E.5.2.1Timepoint(s) of evaluation of this end point
1. Part 1 Cycle 1: Day 1 Predose, Day 4 Predose, 1-3 hrs & 6hrs, Day 5 Predose, Day 8, 15 & 22 Predose and 2 hrs ; Cycle 2: Day 1 Predose, 1-3 hrs and 6 hrs, Day 2 & 15 Predose, Cycle 3-5 Day 1 Predose; Part 2: Cycle Day 1, 4, 5, 15, 22 Predose, Cycle 2 Day 1 Predose & 2 hrs, Day 2 Predose, Cycle 3-5 Day 1 Predose.

2. Screening & Cycle 3+ Day 1.

3-7. Cycle 2 Day 1 (±3 days), Cycle 3 Day 1 (±3 days), Cycle 4 Day 1(±3 days), then every 3 Cycles (±3 days) thereafter until CR; for participants achieving CR after 3 Cycles, every 6 Cycles (±3 days), at the time of transplant (if applicable) and at EOT.
1. Parte 1 Ciclo 1: Día 1 Predosis, Día 4 Predosis, 1-3 hrs y 6hrs, Día 5 Predosis, Día 8, 15 & 22 Predosis y 2 hrs ; Ciclo 2: Día 1 Predosis, 1-3 hrs y 6 hrs, Día 2 y 15 Predosis, Ciclo 3-5 Día 1 Predosis; Parte 2: Ciclo Día 1, 4, 5, 15, 22 Predosis, Ciclo 2 Día 1 Predosis y 2 hrs, Día 2 Predosis, Ciclo 3-5 Día 1 Predosis.

2. Selección y Ciclo 3+ Día 1.

3-7. Ciclo 2 Día 1 (±3 días), Ciclo 3 Día 1 (±3 días), Ciclo 4 Día 1(±3 días), después cada 3 ciclos (±3 días) hasta la RC; para los participantes que alcancen la RC después de 3 ciclos, cada 6 ciclos (±3 días), en el momento del trasplante (si procede) y en el FDT.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy No
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic Yes
E.6.8Bioequivalence No
E.6.9Dose response Yes
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others Yes
E.6.13.1Other scope of the trial description
Biomarkers
Biomarcadores
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) Yes
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other Yes
E.7.1.3.1Other trial type description
Pediatric study
Estudio pediátrico
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled No
E.8.1.1Randomised No
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group No
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo No
E.8.2.3Other No
E.8.2.4Number of treatment arms in the trial2
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.4.1Number of sites anticipated in Member State concerned3
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA17
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Yes
E.8.6.2Trial being conducted completely outside of the EEA No
E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
E.8.7Trial has a data monitoring committee No
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/study completion is considered as the last scheduled study assessment shown in the Schedule of Activities for the last participant in the study.
Se considera que el final del estudio/ finalización del estudio es la última evaluación del estudio programada que aparece en el Calendario de Evaluaciones para el último participante del estudio.
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years3
E.8.9.1In the Member State concerned months8
E.8.9.1In the Member State concerned days26
E.8.9.2In all countries concerned by the trial years3
E.8.9.2In all countries concerned by the trial months4
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 Yes
F.1.1Number of subjects for this age range: 75
F.1.1.1In Utero No
F.1.1.1.1Number of subjects for this age range: 0
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.2.1Number of subjects for this age range: 0
F.1.1.3Newborns (0-27 days) No
F.1.1.3.1Number of subjects for this age range: 0
F.1.1.4Infants and toddlers (28 days-23 months) Yes
F.1.1.4.1Number of subjects for this age range: 25
F.1.1.5Children (2-11years) Yes
F.1.1.5.1Number of subjects for this age range: 25
F.1.1.6Adolescents (12-17 years) Yes
F.1.1.6.1Number of subjects for this age range: 25
F.1.2Adults (18-64 years) Yes
F.1.2.1Number of subjects for this age range: 5
F.1.3Elderly (>=65 years) No
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Yes
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally Yes
F.3.3.6.1Details of subjects incapable of giving consent
Subjects under age incapable of giving consent personally.
Sujetos menores de edad incapaces de dar su consentimiento personalmente.
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state10
F.4.2 For a multinational trial
F.4.2.1In the EEA 60
F.4.2.2In the whole clinical trial 80
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)
SOC treatment
Tratamiento convencional
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2022-12-27
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2022-10-25
P. End of Trial
P.End of Trial StatusOngoing

Sponsorer og samarbejdspartnere

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