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Uno studio di JNJ-75276617 nei partecipanti con leucemia acuta (cAMeLot-1)

2 novembre 2026 aggiornato da: Janssen Research & Development, LLC

Un primo studio sull'uomo dell'inibitore Menin-KMT2A (MLL1) JNJ-75276617 nei partecipanti con leucemia acuta

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) of bleximenib in phase 1 Part 1 (Dose Escalation) and to determine the safety and tolerability at RP2D in Phase 1 Part 2 (Dose expansion). The purpose of the Phase 2 part of the study is to evaluate the efficacy of bleximenib at the RP2D.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

420

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Australia
      • Clayton, Australia, 3168
        • Reclutamento
        • Monash Medical Centre
      • Perth, Australia, 6000
        • Reclutamento
        • Royal Perth Hospital
      • Southport, Australia, 4211
        • Reclutamento
        • Gold Coast University Hospital
  • Belgio
      • Ghent, Belgio, 9000
        • Reclutamento
        • Ghent University Hospital
  • Brasile
      • Brasília, Brasile, 70390-140
        • Reclutamento
        • IDOR - Regional Brasilia
      • Natal, Brasile, 59062 000
        • Reclutamento
        • Liga Norte Riograndense Contra O Cancer
      • Rio de Janeiro, Brasile, 20230 130
        • Reclutamento
        • Ministerio da Saude Instituto Nacional do Cancer
      • São Paulo, Brasile, 01246 000
        • Reclutamento
        • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
      • São Paulo, Brasile, 01509 900
        • Reclutamento
        • Fundacao Antonio Prudente A C Camargo Cancer Center
      • São Paulo, Brasile, 01401 002
        • Reclutamento
        • IDOR - Regional Sao Paulo
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Reclutamento
        • Vancouver Coastal Health
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X6
        • Reclutamento
        • Princess Margaret Cancer Centre University Health Network
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Reclutamento
        • Hopital Maisonneuve Rosemont
  • Cina
      • Beijing, Cina, 100034
        • Reclutamento
        • Peking University First Hospital
      • Changchun, Cina, 130021
        • Reclutamento
        • The First Hospital of Jilin University
      • Chengdu, Cina, 610041
        • Reclutamento
        • West China Hospital Si Chuan University
      • Guangzhou, Cina, 510515
        • Completato
        • Nanfang Hospital of Southern Medical Hospital
      • Hangzhou, Cina, 310009
        • Reclutamento
        • First Affiliated Hospital Medical School of Zhejiang University
      • Jinan, Cina, 250012
        • Reclutamento
        • Qilu Hospital of Shandong University
      • Nanchang, Cina, 330006
        • Reclutamento
        • The First Affiliated Hospital of NanChang University
      • Nanjing, Cina, 210009
        • Reclutamento
        • Zhongda Hospital Southeast University
      • Tianjin, Cina, 301609
        • Reclutamento
        • Institute of Hematology and Blood Diseases Hospital
      • Wenzhou, Cina, 325000
        • Reclutamento
        • The First Affiliated Hospital of Wenzhou Medical University
      • Wuhan, Cina, 430022
        • Reclutamento
        • Union Hospital Tongji Medical College of Huazhong University of Science and Technology
      • Zhengzhou, Cina, 450003
        • Reclutamento
        • Henan Cancer Hospital
  • Corea del Sud
      • Seoul, Corea del Sud, 05505
        • Reclutamento
        • Asan Medical Center
      • Seoul, Corea del Sud, 03080
        • Reclutamento
        • Seoul National University Hospital
      • Seoul, Corea del Sud, 06351
        • Reclutamento
        • Samsung Medical Center
  • Francia
      • Besançon, Francia, 25000
        • Reclutamento
        • Hopital Jean Minjoz
      • Marseille, Francia, 13009
        • Reclutamento
        • Institut Paoli Calmettes
      • Nantes, Francia, 44093
        • Reclutamento
        • CHU de Nantes hotel Dieu
      • Paris, Francia, 75010
        • Reclutamento
        • Hopital Saint Louis
      • Paris, Francia, 75012
        • Reclutamento
        • Hopital trousseau- APHP
      • Pessac, Francia, 33604
        • Completato
        • Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie
      • Pierre-Bénite, Francia, 69310
        • Reclutamento
        • CHU Lyon Sud
      • Strasbourg, Francia, 67098
        • Reclutamento
        • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
      • Toulouse, Francia, 31059
        • Reclutamento
        • Institut Universitaire du Cancer Toulouse Oncopole
      • Tours, Francia, 37044
        • Reclutamento
        • CHU Bretonneau
      • Vandœuvre-lès-Nancy, Francia, 54511
        • Reclutamento
        • CHRU Nancy Brabois
      • Vandœuvre-lès-Nancy, Francia, 54500
        • Reclutamento
        • CHRU de Nancy - Hopitaux de Brabois
      • Villejuif, Francia, 94805
        • Reclutamento
        • Gustave Roussy
  • Giappone
      • Fukuoka, Giappone, 812-0054
        • Attivo, non reclutante
        • Kyushu University Hospital
      • Fukushima, Giappone, 960 1295
        • Attivo, non reclutante
        • Fukushima Medical University Hospital
      • Kanazawa, Giappone, 920 8641
        • Attivo, non reclutante
        • Kanazawa University Hospital
      • Kashiwa, Giappone, 277-8577
        • Attivo, non reclutante
        • National Cancer Center Hospital East
      • Kobe, Giappone, 650 0047
        • Completato
        • Kobe City Medical Center General Hospital
      • Maebashi, Giappone, 371-0821
        • Completato
        • Gunmaken Saiseikai Maebashi Hospital
      • Nagoya, Giappone, 466-8560
        • Completato
        • Nagoya University Hospital
      • Sapporo, Giappone, 060-8648
        • Completato
        • Hokkaido University Hospital
      • Tokyo, Giappone, 141-8625
        • Attivo, non reclutante
        • NTT Medical Center Tokyo
      • Yamagata, Giappone, 990 2331
        • Completato
        • Yamagata University Hospital
      • Yoshida, Giappone, 910-1193
        • Completato
        • University of Fukui Hospital
  • Israele
      • Haifa, Israele, 3436212
        • Reclutamento
        • Carmel Medical Center
      • Jerusalem, Israele, 9112001
        • Reclutamento
        • Hadassah University Hospita Ein Kerem
      • Ramat Gan, Israele, 52621
        • Reclutamento
        • Sheba Medical Center
      • Tel Aviv, Israele, 6423906
        • Reclutamento
        • Tel Aviv Sourasky Medical Center
  • Regno Unito
      • Cardiff, Regno Unito, CF14 4XW
        • Reclutamento
        • University Hospital of Wales
      • Leeds, Regno Unito, LS9 7TF
        • Reclutamento
        • Leeds Teaching Hospitals NHS Trust
      • Liverpool, Regno Unito, L7 8YA
        • Reclutamento
        • The Clatterbridge Cancer Centre
      • London, Regno Unito, SE1 9RT
        • Reclutamento
        • Guys and St Thomas NHS Foundation Trust
      • London, Regno Unito, W1T 7HA
        • Reclutamento
        • University College London Hospitals
      • Manchester, Regno Unito, M20 4BX
        • Reclutamento
        • The Christie Nhs Foundation Trust
      • Oxfordshire, Regno Unito, OX3 7LE
        • Reclutamento
        • Oxford University Hospitals NHS Trust
      • Plymouth, Regno Unito, PL6 8DH
        • Reclutamento
        • University Hospitals Plymouth NHS Trust
  • Spagna
      • Barcelona, Spagna, 08036
        • Reclutamento
        • Hosp Clinic de Barcelona
      • Barcelona, Spagna, 08035
        • Reclutamento
        • Hosp Univ Vall D Hebron
      • Madrid, Spagna, 28009
        • Reclutamento
        • Hospital Infantil Universitario Nino Jesus
      • Madrid, Spagna, 28007
        • Reclutamento
        • Hosp. Gral. Univ. Gregorio Maranon
      • Madrid, Spagna, 28040
        • Reclutamento
        • Hosp Univ Fund Jimenez Diaz
      • Pamplona, Spagna, 31008
        • Reclutamento
        • Clinica Univ. de Navarra
      • Salamanca, Spagna, 37007
        • Reclutamento
        • Hosp Clinico Univ de Salamanca
      • Seville, Spagna, 41013
        • Reclutamento
        • Hosp. Virgen Del Rocio
      • Valencia, Spagna, 46010
        • Reclutamento
        • Hosp. Clinico Univ. de Valencia
  • Stati Uniti
    • California
      • Duarte, California, Stati Uniti, 91010
        • Reclutamento
        • City of Hope
      • Orange, California, Stati Uniti, 92868
        • Completato
        • University of California Irvine Medical Center
      • San Francisco, California, Stati Uniti, 94143
        • Reclutamento
        • University of California San Francisco
      • San Francisco, California, Stati Uniti, 94158
        • Reclutamento
        • UCSF Benioff Children's Hospital
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60637
        • Reclutamento
        • University of Chicago
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46237
        • Reclutamento
        • St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation
    • Kentucky
      • Louisville, Kentucky, Stati Uniti, 40207
        • Completato
        • Norton Cancer Institute
    • Maine
      • South Portland, Maine, Stati Uniti, 04106
        • Reclutamento
        • Maine Health
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02114
        • Reclutamento
        • Massachusetts General Hospital
      • Boston, Massachusetts, Stati Uniti, 02115
        • Reclutamento
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, Stati Uniti, 48201 2013
        • Completato
        • Karmanos Cancer Institute
      • Grand Rapids, Michigan, Stati Uniti, 49546
        • Reclutamento
        • Start Midwest
    • New Mexico
      • Albuquerque, New Mexico, Stati Uniti, 87131
        • Reclutamento
        • University of New Mexico
    • New York
      • Buffalo, New York, Stati Uniti, 14263
        • Reclutamento
        • Roswell Park Comprehensive Cancer Center
      • New York, New York, Stati Uniti, 10016
        • Reclutamento
        • NYU Langone Medical Center
      • The Bronx, New York, Stati Uniti, 10467
        • Reclutamento
        • Montefiore Medical Center
    • Oregon
      • Portland, Oregon, Stati Uniti, 97239
        • Reclutamento
        • Oregon Health And Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19111
        • Completato
        • Fox Chase Cancer Center
    • Tennessee
      • Knoxville, Tennessee, Stati Uniti, 37920
        • Reclutamento
        • University of Tennessee Medical Center
    • Texas
      • Dallas, Texas, Stati Uniti, 75246
        • Reclutamento
        • Baylor University Medical Center
      • Houston, Texas, Stati Uniti, 77030
        • Reclutamento
        • MD Anderson
      • Houston, Texas, Stati Uniti, 77030-2740
        • Reclutamento
        • Houston Methodist Hospital
      • San Antonio, Texas, Stati Uniti, 78229
        • Reclutamento
        • San Antonio Methodist TX Transplant Physicians Group
    • Virginia
      • Richmond, Virginia, Stati Uniti, 23298
        • Reclutamento
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, Stati Uniti, 98104
        • Reclutamento
        • Swedish Cancer Institute
    • Wisconsin
      • Milwaukee, Wisconsin, Stati Uniti, 53226
        • Reclutamento
        • Medical College of WI at Froedtert
  • Taiwan
      • Taichung, Taiwan, 404327
        • Reclutamento
        • China Medical University Hospital
      • Tainan, Taiwan, 704
        • Reclutamento
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10043
        • Reclutamento
        • National Taiwan University Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

2 anni e precedenti (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

Phase 1:

  • Age 2 years to less than (<) 18 years of age (pediatric cohort only), all other cohorts 18 years and above
  • Relapsed or refractory (R/R) acute leukemia and has exhausted, or is ineligible for, available therapeutic options
  • Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A), nucleophosmin 1 gene (NPM1) or nucleoporin 98 gene or nucleoporin 214 gene (NUP98 or NUP214) alterations

Phase: 2

  • Participants greater than 18 years are eligible
  • Must have had an initial diagnosis of acute myeloid leukemia (AML) per the WHO 2022 classification criteria and have relapsed/refractory disease
  • AML harboring KMT2A-r (gene rearrangement/translocation) or NPM1 mutations only

For Both Phase 1 and 2:

  • Pretreatment clinical laboratory values meeting the following criteria: (a) Hematology: white blood cell (WBC) count <= 20*10^9/liter (L) and (b) renal function; For adult participants, estimated or measured glomerular filtration rate >= 30 milliliter per minute (mL/min) per four variable MDRD equation. For pediatric participants an estimated or measured glomerular filtration rate >=40 mL/min per the CKiD (Chronic Kidney Disease in Children) Schwartz formula
  • Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2. Pediatric participants only: Performance status >=70 by Lansky scale (for participants < 16 years of age) or >=70 Karnofsky scale (for participants >=16 years of age)
  • A female of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment
  • Participant must agree to all protocol required contraception requirements and avoid sperm or egg donations or freezing for future reproductive use while on study and for 90 days (males) or 6 months (females) after the last dose of study treatment

Exclusion Criteria:

  • Acute promyelocytic leukemia, diagnosis of Down syndrome associated leukemia or juvenile myelomonocytic leukemia according to World Health Organization (WHO) 2016 criteria
  • Active central nervous system (CNS) disease
  • Prior solid organ transplantation
  • QTc according to Fridericia's formula (QTcF) for males >= 450 millisecond (msec) or for females >= 470 msec. Participants with a family history of Long QT syndrome are excluded
  • Exclusion criteria related to stem cell transplant: a. Received prior treatment with allogenic bone marrow or stem cell transplant <=3 months before the first dose of study treatment ; b. Has evidence of graft versus host disease; c. Received donor lymphocyte infusion <=1 month before the first dose of study treatment; d. Requires immunosuppressant therapy (exception: daily doses <=10 milligrams (mg) prednisone or equivalent are allowed for adrenal replacement)
  • Prior cancer immunotherapy within 4 weeks prior to enrollment or blinatumomab within 2 weeks prior to enrollment. Additional prior cancer therapies must not be given within 4 weeks prior to enrollment or 5 half-lives of the agent (whichever is shorter)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Bleximenib

Participants in Phase 1 Part 1 (dose escalation) will receive bleximenib orally. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by Study Evaluation Team (SET) until the recommended Phase 2 Doses (RP2Ds) have been identified. Participants in Phase 1 Part 2 (dose expansion) will receive bleximenib orally at the RP2D(s) determined in Part 1. In Phase 2 participants will receive bleximenib at the RP2D to evaluate anti-leukemia activity and demonstrate acceptable safety at the RP2D(s).
Droga: Bleximenib

Bleximenib is administered orally.

Altri nomi:
  • JNJ-75276617

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Phase 1: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Lasso di tempo: Up to 4 years and 9 months

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Up to 4 years and 9 months
Phase 1: Number of Participants with AEs by Severity
Lasso di tempo: Up to 4 years and 9 months

Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Up to 4 years and 9 months
Phase 1: Part 1: Percentage of Participants with Dose-Limiting Toxicity (DLT)
Lasso di tempo: Up to 28 days Cycle 1

Percentage of participants with DLT will be assessed accordingly to national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.
Up to 28 days Cycle 1
Phase 2: Rate of Complete Remission or Complete Remission with Partial Hematologic Recovery (CR/CRh)
Lasso di tempo: Up to 4 years and 9 months

Rate of CR/CRh is defined as the percentage of participants achieving a CR or CRh at any time post-treatment.
Up to 4 years and 9 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Phase 1 and 2: Plasma Concentration of Bleximenib
Lasso di tempo: Up to 4 years and 9 months

Plasma concentration of bleximenib will be reported.
Up to 4 years and 9 months
Phase 1 and 2: Overall Response Rate (ORR)
Lasso di tempo: Up to 4 years and 9 months

ORR is defined as the percentage of participants who achieve any response.
Up to 4 years and 9 months
Phase 1: Duration of Response (DOR)
Lasso di tempo: Up to 4 years and 9 months

DOR will be calculated among responders from the date of initial documentation of a response to the date of first documented evidence of relapse, as defined in the disease-specific response criteria, or death due to any cause, whichever occurs first.
Up to 4 years and 9 months
Phase 1 and 2: Time To Response (TTR)
Lasso di tempo: Up to 4 years and 9 months

TTR is defined for the responders as the time from the date of the first dose of bleximenib to the date of the first documented response.
Up to 4 years and 9 months
Phase 2: Duration of Complete Response (CR)/Complete Remission With Partial Hematologic Recovery (CRh)
Lasso di tempo: Up to 4 years and 9 months

The duration of CR/CRh is defined from the date of first CR or CRh response achieved to the date of first evidence of relapsed disease or death due to any cause, whichever occurs first, for participants who achieve a CR or CRh.
Up to 4 years and 9 months
Phase 2: Time To CR/CRh
Lasso di tempo: Up to 4 years and 9 months

Time to CR/CRh is defined for responders as the time from the date of the first dose of bleximenib to the date of first achieving either CR or CRh, depending on which milestone is reached.
Up to 4 years and 9 months
Phase 2: Event-free survival (EFS)
Lasso di tempo: Up to 4 years and 9 months

EFS is defined as the time from the date of first dose of study treatment to the date of treatment failure, relapse, or death due to any cause, whichever occurs first.
Up to 4 years and 9 months
Phase 2: Overall survival (OS)
Lasso di tempo: Up to 4 years and 9 months

OS is defined from the date of first dose of study treatment to the date of death due to any cause.
Up to 4 years and 9 months
Phase 2: Measurable Residual Disease (MRD) Negativity Among Participants Achieving CR/CRh/CRi
Lasso di tempo: Up to 4 years and 9 months

MRD-negative rate is defined as the percentage of participants who are MRD-negative at any timepoint after the first dose of bleximenib in the responders.
Up to 4 years and 9 months
Phase 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Lasso di tempo: Up to 4 years and 9 months

An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A Serious AE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Up to 4 years and 9 months
Phase 2: Number of Participants Reporting Transfusion Independence
Lasso di tempo: Up to 4 years and 9 months

Transfusion independence is defined as independence from red blood cells (RBC) and platelet transfusions during any 56-day interval after receiving study treatment.
Up to 4 years and 9 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Janssen Research & Development, LLC

Investigatori

  • Direttore dello studio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

19 maggio 2021

Completamento primario (Stimato)

29 dicembre 2028

Completamento dello studio (Stimato)

22 settembre 2030

Date di iscrizione allo studio

Primo inviato

22 marzo 2021

Primo inviato che soddisfa i criteri di controllo qualità

22 marzo 2021

Primo Inserito (Effettivo)

23 marzo 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • CR108998
  • 75276617ALE1001 (Altro identificatore: Janssen Research & Development, LLC)
  • 2023-506581-31-00 (Identificatore di registro: EUCT number)
  • 2023 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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