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ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS

3 novembre 2026 mis à jour par: Washington University School of Medicine

A Phase I Study of ATRN-119, an ATR Inhibitor, in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS

This single-center, open-label, phase I study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antileukemic activity of ATRN-119 (mosipasertib) alone and in combination with decitabine in patients with TP53-mutated AML or higher-risk myelodysplastic syndrome (HR-MDS). The primary objective is to identify the maximum tolerated dose (MTD) and recommended dose(s) for expansion (RDE) of ATRN-119 (mosipasertib) plus decitabine. The study is based on the hypothesis that ATR inhibition with ATRN-119 (mosipasertib) will enhance sensitivity to decitabine in TP53-mutated disease, resulting in deeper and more durable clinical responses.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

36

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Missouri
      • St Louis, Missouri, États-Unis, 63110
        • Washington University School of Medicine
        • Chercheur principal:
          • Geoffrey L Uy, MD
        • Sous-enquêteur:
          • Daniel C Link, MD
        • Sous-enquêteur:
          • J Scott Beeler, MD, PhD
        • Sous-enquêteur:
          • Fei Wan, PhD
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Diagnosis of AML or higher-risk MDS (HR-MDS) according to the World Health Organization (WHO) 5th Edition or International Consensus Classification (ICC) 2022 criteria.

    • HR-MDS is defined as:

      • IPSS-R (score > 3.5) or IPSS-M (score > 0.5) OR
      • ≥ 10% bone marrow blasts

  • At least one of the following demonstrated on standard of care testing:

    • A pathogenic or likely pathogenic TP53 mutation with a VAF ≥10%
    • A TP53 or chromosome 17p deletion detected in ≥10% of cells by a cytogenetic assay
    • >20% p53-positive cells by immunohistochemistry

  • Meeting R/R disease criteria for AML or HR-MDS:

    • Patients with R/R AML must have received at least 1 prior AML-directed treatment regimen appropriate for their disease and fitness. Patients with FLT3, IDH1, IDH2, or NPM1 mutations must also have previously received, or been deemed ineligible for, an approved targeted therapy directed against the relevant mutation. In addition, patients must meet at least one of the following criteria:

      • Disease progression during treatment with, or failure to achieve CR, CRh, or CRi after ≥ 2 cycles of a hypomethylating agent (HMA) plus venetoclax.
      • Disease progression during treatment with, or failure to achieve CR, CRh, or CRi after ≥ 4 cycles of HMA-based therapy when venetoclax was contraindicated, not tolerated, or otherwise considered clinically inappropriate.
      • First relapse with an initial remission duration < 12 months
      • First relapse following failed salvage chemotherapy
      • Relapse after allogeneic hematopoietic cell transplant
      • Second or subsequent relapse

    • Patients with R/R HR-MDS must have received at least 1 prior MDS-directed treatment regimen appropriate for their disease and fitness. Patients with IDH1 mutations must also have previously received, or been deemed ineligible for, an approved targeted therapy directed against the relevant mutation. Patients must meet at least one of the following criteria:

      • Disease progression during treatment with, or failure to achieve CR, CRh, or CRi after ≥ 4 cycles of HMA-based therapy or 2 cycles of HMA in combination with another agent, including an investigational agent as part of a clinical trial or in routine clinical care.
      • Relapse after allogeneic hematopoietic cell transplant
      • Second or subsequent relapse

  • At least 18 years of age.

  • ECOG performance status ≤ 2

  • Adequate organ function within 28 days prior to the first dose of mosipasertib as defined below:

    • Total bilirubin ≤ 2.0 x IULN; patients with known or suspected Gilbert's syndrome may have total bilirubin ≤ 3 x IULN
    • AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN
    • Creatinine clearance ≥ 45 mL/min/1.73 m^2 by Cockcroft-Gault formula

  • The effects of mosipasertib and decitabine on the developing human fetus are unknown. For this reason, people of childbearing potential and people able to father a child must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months after the last dose of mosipasertib or decitabine on study (whichever is later) for people of childbearing potential and 3 monthsafter the last dose of mosipasertib or decitabine on study (whichever is later) for people able to father a child.

  • Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

Exclusion Criteria:

  • Active CNS involvement by AML requiring therapeutic intervention.
  • Active graft-versus-host disease (GVHD) requiring systemic immunosuppressive therapy except for low-dose steroids (prednisone ≤ 10 mg per day or other steroid equivalent)
  • Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.
  • Currently receiving any other investigational agents.
  • Concomitant systemic treatment with inhibitors of BCRP, OATP1B1, OATP1B3, OAT1, OAT3, OCT2, MATE1, or MATE2-K. Patients may be eligible after a washout period of at least 7 days or 5 half-lives, whichever is longer, prior to the first dose of ATRN-119.
  • Concomitant systemic treatment with strong inhibitors or inducers of CYP enzymes. Patients may be eligible after a washout period of 5 half-lives or 14 days (whichever is longer) before PK Run-In Day 1 or C1D1 (whichever is applicable) for strong inducers, and 5 half-lives or 7 days (whichever is longer) before PK Run-In Day 1 or C1D1 (whichever is applicable) for strong inhibitors.
  • A history of allergic reactions attributed to or known hypersensitivity to compounds of similar chemical or biologic composition to mosipasertib, decitabine, or other agents used in the study.
  • Persistent corrected QT interval using Fridericia's formula (QTcF) >480 msec (CTCAE v6.0 ≥ grade 2), except in patients with bundle branch block and/or ventricular paced rhythm for whom QTc cannot be reliably assessed using standard correction methods.
  • Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, clinically significant autoimmune disease requiring systemic therapy, symptomatic congestive heart failure, unstable angina pectoris, or clinically significant or uncontrolled cardiac arrhythmia. Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Function Classification; to be eligible for this trial, patients should be a class 2B or better.
  • Conditions that may impair oral drug administration or absorption, including inability to swallow oral medications, malabsorption syndromes, or other clinically significant gastrointestinal disorders.
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days of PK Run-In Day 1/Cycle 1 Day 1.
  • HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing is not required in the absence of known history of infection.
  • Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load by PCR on suppressive therapy are eligible. HBV testing is not required in the absence of known history of infection.
  • History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing is not required in the absence of known history of infection.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Part A Dose Escalation Dose Level 1: ATRN-119
  • Patients will take ATRN-119 at the assigned dose level by mouth once per day on Days 1-28 of each 28-day cycle.
  • Patients in Part A may (but are not required to) transition to the current dose level being evaluated in Part B (and thus receive decitabine concurrently with mosipasertib) following completion of the Cycle 1 DLT evaluation period for all patients in their assigned dose level, provided that dose level is determined to be safe. In order to transition from Part A to Part B, a patient must have persistent AML or HR-MDS (meaning they must NOT have achieved a CR without MRD) and must meet all eligibility criteria. In addition, both they and their physician must be in agreement that the decision to transition is desired and acceptable.
  • Patients may continue treatment for up to 24 total cycles across Parts A and B unless disease is considered refractory after Cycle 4, or until disease progression, unacceptable toxicity, or withdrawal, whichever occurs first.
Médicament: ATRN-119

Provided in 50 mg and 100 mg capsules or 50 mg and 250 mg tablets and are administered by mouth.

Autres noms:
  • Mosipasertib
Expérimental: Part A Dose Escalation Dose Level 2: ATRN-119
  • Patients will take ATRN-119 at the assigned dose level by mouth once per day on Days 1-28 of each 28-day cycle.
  • Patients in Part A may (but are not required to) transition to the current dose level being evaluated in Part B (and thus receive decitabine concurrently with mosipasertib) following completion of the Cycle 1 DLT evaluation period for all patients in their assigned dose level, provided that dose level is determined to be safe. In order to transition from Part A to Part B, a patient must have persistent AML or HR-MDS (meaning they must NOT have achieved a CR without MRD) and must meet all eligibility criteria. In addition, both they and their physician must be in agreement that the decision to transition is desired and acceptable.
  • Patients may continue treatment for up to 24 total cycles across Parts A and B unless disease is considered refractory after Cycle 4, or until disease progression, unacceptable toxicity, or withdrawal, whichever occurs first.
Médicament: ATRN-119

Provided in 50 mg and 100 mg capsules or 50 mg and 250 mg tablets and are administered by mouth.

Autres noms:
  • Mosipasertib
Expérimental: Part A Dose Escalation Dose Level 3: ATRN-119
  • Patients will take ATRN-119 at the assigned dose level by mouth once per day on Days 1-28 of each 28-day cycle.
  • Patients in Part A may (but are not required to) transition to the current dose level being evaluated in Part B (and thus receive decitabine concurrently with mosipasertib) following completion of the Cycle 1 DLT evaluation period for all patients in their assigned dose level, provided that dose level is determined to be safe. In order to transition from Part A to Part B, a patient must have persistent AML or HR-MDS (meaning they must NOT have achieved a CR without MRD) and must meet all eligibility criteria. In addition, both they and their physician must be in agreement that the decision to transition is desired and acceptable.
  • Patients may continue treatment for up to 24 total cycles across Parts A and B unless disease is considered refractory after Cycle 4, or until disease progression, unacceptable toxicity, or withdrawal, whichever occurs first.
Médicament: ATRN-119

Provided in 50 mg and 100 mg capsules or 50 mg and 250 mg tablets and are administered by mouth.

Autres noms:
  • Mosipasertib
Expérimental: Part B Dose Escalation Dose Level 1: ATRN-119 + Decitabine
  • Patients will take ATRN-119 at the assigned dose level by mouth once per day on Days 1-28 and 20 mg/m^2 of decitabine given intravenously (IV) on Days 1-5 of each 28-day cycle.
  • Patients may continue treatment for up to 24 total cycles unless disease is considered refractory after Cycle 4, or until disease progression, unacceptable toxicity, or withdrawal, whichever occurs first.
Médicament: ATRN-119

Provided in 50 mg and 100 mg capsules or 50 mg and 250 mg tablets and are administered by mouth.

Autres noms:
  • Mosipasertib
Médicament: Decitabine

Decitabine is provided as a 50 mg injection in a single-dose vial.

Autres noms:
  • Dacogen
Expérimental: Part B Dose Escalation Dose Level 2: ATRN-119 + Decitabine
  • Patients will take ATRN-119 at the assigned dose level by mouth once per day on Days 1-28 and 20 mg/m^2 of decitabine given intravenously (IV) on Days 1-5 of each 28-day cycle.
  • Patients may continue treatment for up to 24 total cycles unless disease is considered refractory after Cycle 4, or until disease progression, unacceptable toxicity, or withdrawal, whichever occurs first.
Médicament: ATRN-119

Provided in 50 mg and 100 mg capsules or 50 mg and 250 mg tablets and are administered by mouth.

Autres noms:
  • Mosipasertib
Médicament: Decitabine

Decitabine is provided as a 50 mg injection in a single-dose vial.

Autres noms:
  • Dacogen
Expérimental: Part B Dose Escalation Dose Level 3: ATRN-119 + Decitabine
  • Patients will take ATRN-119 at the assigned dose level by mouth once per day on Days 1-28 and 20 mg/m^2 of decitabine given intravenously (IV) on Days 1-5 of each 28-day cycle.
  • Patients may continue treatment for up to 24 total cycles unless disease is considered refractory after Cycle 4, or until disease progression, unacceptable toxicity, or withdrawal, whichever occurs first.
Médicament: ATRN-119

Provided in 50 mg and 100 mg capsules or 50 mg and 250 mg tablets and are administered by mouth.

Autres noms:
  • Mosipasertib
Médicament: Decitabine

Decitabine is provided as a 50 mg injection in a single-dose vial.

Autres noms:
  • Dacogen

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number and grade of treatment-emergent adverse events (TEAEs) as assessed via CTCAE v6.0 (All Patients)
Délai: From start of treatment until 30 days after last dose of ATRN-119 (approximately 23 months)
From start of treatment until 30 days after last dose of ATRN-119 (approximately 23 months)
Incidence of dose-limiting toxicities (DLTs) during Cycle 1 as assessed via CTCAE v6.0 (All Patients)
Délai: From Cycle 1 Day 1 to end of Cycle 1 Day 28/Cycle 1 Day 42 (total time 28-42 days)

The DLT evaluation period is 28 days from initiation of study treatment (Cycle 1), except in cases of persistent neutropenia meeting hematologic DLT criteria, for which the observation window will extend to 42 days from treatment initiation. DLTs are defined in the protocol.
From Cycle 1 Day 1 to end of Cycle 1 Day 28/Cycle 1 Day 42 (total time 28-42 days)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Rate of Complete Remission (CR) (All Patients)
Délai: Through completion of treatment (estimated total time 22 months)

European LeukemiaNet (ELN) 2022 Response Criteria assesses AML and the International Working Group (IWG) 2023 Response Criteria assesses Higher-Risk MDS (HR-MDS).

CR AML: Bone marrow blasts < 5%; absence of circulating blasts; absence of extramedullary disease; ANC ≥ 1.0 x 10^9/L (1,000/μL); platelet count ≥ 100 x 10^9/L (100,000/μL).

CR HR-MDS: Bone marrow: < 5% myeloblasts; dysplasia may persist and peripheral blood: hemoglobin ≥ 10 g/dL, platelets ≥ 100 x 10^9/L, neutrophils ≥ 1.0 x 10^9/L, blasts 0%
Through completion of treatment (estimated total time 22 months)
Rate of Complete Remission with partial hematologic recovery (CRh) (All Patients)
Délai: Through completion of treatment (estimated total time 22 months)

European LeukemiaNet (ELN) 2022 Response Criteria assesses AML and the International Working Group (IWG) 2023 Response Criteria assesses Higher-Risk MDS (HR-MDS).

CRh is defined according to the ELN 2022 Response Criteria: ANC ≥ 0.5 x 10^9/L (500 μL) and platelet count ≥ 50 x 10^9/L (50,000/μL), otherwise all other CR criteria met

CRh is defined according to the IWG 2023 Response Criteria: Bone marrow: < 5% myeloblasts; dysplasia may persist; Peripheral blood: not meeting criteria for CR or CRL; no hemoglobin threshold required, platelets ≥ 50 x 10^9/L, neutrophils ≥ 0.5 x 10^9/L, blasts 0%
Through completion of treatment (estimated total time 22 months)
Rate of Partial Remission (PR) (All Patients)
Délai: Through completion of treatment (estimated total time 22 months)

European LeukemiaNet (ELN) 2022 Response Criteria assesses AML and the International Working Group (IWG) 2023 Response Criteria assesses Higher-Risk MDS (HR-MDS).

PR is defined according to the ELN 2022 Response Criteria: All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pre-treatment bone marrow blast percentage by at least 50%

PR is defined according to the IWG 2023 Response Criteria: All CR criteria except: Bone marrow blasts decreased by ≥ 50% over pretreatment but still ≥ 5% and Cellularity and morphology not relevant
Through completion of treatment (estimated total time 22 months)
Duration of Response (DoR) (All Patients)
Délai: From first documented response until disease progression or death (up to 48 months)

DoR will be measured from the first documented response until earliest date of disease progression or death from any cause, as defined in the protocol or disease-specific criteria (ELN 2022 for AML and IWG 2023 for HR-MDS). DOR will be summarized among responders only. Individuals who do not exhibit any disease progression or death during the follow-up period are censored at the last date of the response assessment.
From first documented response until disease progression or death (up to 48 months)
Event-free Survival (EFS) (All Patients)
Délai: From Cycle 1 Day 1 to treatment failure, relapse after response, progression, or death (up to 48 months)

EFS will be measured from Cycle 1 Day 1 to treatment failure, relapse after response, progression, or death from any cause, consistent with protocol definitions and disease-specific response criteria (ELN 2022 for AML and IWG 2023 for HR-MDS). EFS will be summarized in the efficacy-evaluable population. Participants without an event will be censored at the last disease assessment date at which they were known to be event-free.
From Cycle 1 Day 1 to treatment failure, relapse after response, progression, or death (up to 48 months)
Overall Survival (OS) (All Patients)
Délai: From Cycle 1 Day 1 to death from any cause (up to 48 months)

OS will be measured from Cycle 1 Day 1 to death from any cause. Participants alive at last follow-up will be censored on the date last known alive. OS will be summarized in all treated participants.
From Cycle 1 Day 1 to death from any cause (up to 48 months)
Rate of Complete Remission with incomplete count recovery (CRi) (AML Patients only)
Délai: Through completion of treatment (estimated total time 22 months)

Response is assessed according to the ELN 2022 Response Criteria for AML.

CRi is defined as all CR criteria except for residual neutropenia < 1.0 x 10^9/L (500/μL) or thrombocytopenia < 100 x 10^9/L (50,000/μL); CRi should only include patients not meeting the definition of CRh.
Through completion of treatment (estimated total time 22 months)
Rate of morphologic leukemia-free state (MLFS) (AML Patients only)
Délai: Through completion of treatment (estimated total time 22 months)

Response is assessed according to the ELN 2022 Response Criteria for AML.

MLFS is defined as bone marrow blasts < 5%; absence of circulating blasts; absence of extramedullary disease; no hematologic recovery required.
Through completion of treatment (estimated total time 22 months)
Rate of composite Complete Remission (cCR) (AML Patients only)
Délai: Through completion of treatment (estimated total time 22 months)

Response is assessed according to the ELN 2022 Response Criteria for AML.

cCR is defined as complete remission (CR) + complete remission with partial hematologic recovery (CRh) + complete remission with incomplete hematologic recovery (CRi)
Through completion of treatment (estimated total time 22 months)
Overall Response Rate (ORR) (AML Patients only)
Délai: Through completion of treatment (estimated total time 22 months)

Response is assessed according to the ELN 2022 Response Criteria for AML. ORR is defined as complete remission (CR) + complete remission with partial hematologic recovery (CRh) + complete remission with incomplete hematologic recovery (CRi) + partial remission (PR) + morphologic leukemia-free state (MLFS)
Through completion of treatment (estimated total time 22 months)
Rate of Complete Remission (CR) equivalent (HR-MDS patients only)
Délai: Through completion of treatment (estimated total time 22 months)

CR is assessed according to the IWG 2023 Response Criteria for HR-MDS.

CR: Bone marrow: < 5% myeloblasts; dysplasia may persist; Peripheral blood: hemoglobin ≥ 10 g/dL, platelets ≥ 100 x 10^9/L, neutrophils ≥ 1.0 x 10^9/L, blasts 0%
Through completion of treatment (estimated total time 22 months)
Rate of Complete Remission with limited count recovery (CRL) (HR-MDS patients only)
Délai: Through completion of treatment (estimated total time 22 months)

CRL is assessed according to the IWG 2023 Response Criteria for HR-MDS.

CRL (CRuni and CRbi): Bone marrow: < 5% myeloblasts; dysplasia may persist; Peripheral blood: blasts 0%; Complete remission unilineage (CRuni): peripheral blood not meeting CR but only one of the following: hemoglobin ≥ 10 g/dL, platelets ≥ 100 x 10^9/L, neutrophils ≥ 1.0 x 10^9/L Complete remission bilineage (CRbi): peripheral blood not meeting CR but only two of the following: hemoglobin ≥ 10 g/dL, platelets ≥ 100 x 10^9/L, neutrophils ≥ 1.0 x 10^9/L
Through completion of treatment (estimated total time 22 months)
Rate of Hematological Improvement (HI) (HR-MDS patients only)
Délai: Through completion of treatment (estimated total time 22 months)

HI is assessed according to the IWG 2018 Response Criteria for HR-MDS.

HI: Not meeting criteria for complete remission (CR) (or CR equivalent) or complete remission unilineage (CRuni) or complete remission with limited count recovery (CRL); HIerythroid (HI-E); HIplatelets (HI-P); HIneutrophils (HI-N).
Through completion of treatment (estimated total time 22 months)
Rate of composite Complete Remission (cCR) (HR-MDS patients only)
Délai: Through completion of treatment (estimated total time 22 months)

cCR is assessed according to the IWG 2023 Response Criteria for HR-MDS.

cCR is defined as complete remission (CR) + complete remission (CR) equivalent + complete remission with limited count recover (CRL) + complete remission with partial hematologic recovery (CRh)
Through completion of treatment (estimated total time 22 months)
Overall Response Rate (ORR) (HR-MDS patients only)
Délai: Through completion of treatment (estimated total time 22 months)

Response is assessed via the IWG 2023 Response Criteria for HR-MDS. ORR is defined as complete remission (CR) + complete remission (CR) equivalent + complete remission with limited count recover (CRL) + complete remission with partial hematologic recovery (CRh) + partial remission (PR) + hematological improvement (HI)
Through completion of treatment (estimated total time 22 months)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Washington University School of Medicine

Collaborateurs

National Cancer Institute (NCI)
Aprea Therapeutics
The V Foundation for Cancer Research

Les enquêteurs

  • Chercheur principal: Geoffrey L Uy, MD, Washington University School of Medicine

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

30 novembre 2026

Achèvement primaire (Estimé)

31 octobre 2029

Achèvement de l'étude (Estimé)

30 novembre 2031

Dates d'inscription aux études

Première soumission

20 mai 2026

Première soumission répondant aux critères de contrôle qualité

20 mai 2026

Première publication (Réel)

1 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 202609141
  • P50CA171963 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

De-identified individual participant data underlying the results reported in publications arising from this study will be made available to qualified investigators.

Délai de partage IPD

Data will become available beginning 6 months after publication of the primary study results and will remain available for at least 5 years thereafter.

Critères d'accès au partage IPD

De-identified individual participant data will be made available upon reasonable request to the Principal Investigator following publication of the primary study results. Requests must include a scientifically sound proposal and may require execution of a data use agreement and approval by Washington University and other applicable oversight bodies.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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