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Primo studio sull'uomo dell'infusione di SAR443579 in partecipanti di sesso maschile e femminile di almeno 12 anni di età con leucemia mieloide acuta recidivante o refrattaria (LMA R/R), leucemia linfoblastica acuta a cellule B (B-ALL) o leucemia linfoblastica acuta a cellule B (B-ALL) o mielodisplasia (HR-MDS)

8 giugno 2026 aggiornato da: Sanofi

Uno studio in aperto, primo nell'uomo, di aumento della dose di SAR443579 somministrato come agente singolo mediante infusione endovenosa in pazienti con leucemia mieloide acuta recidivante o refrattaria (R/R AML), leucemia linfoblastica acuta a cellule B (B-ALL ) o mielodisplasia ad alto rischio (HR-MDS)

Si tratta di uno studio in aperto, multicentrico, di fase 1/fase 2, di incremento della dose e di espansione della dose per valutare la sicurezza, la farmacocinetica, la farmacodinamica e l'attività antileucemica di SAR443579 in varie neoplasie ematologiche.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

2,5 anni.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

101

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.

Luoghi di studio

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Investigational Site Number :0360002
      • Melbourne, Victoria, Australia, 3004
        • Investigational Site Number :0360001
  • Cina
      • Tianjin, Cina, 300020
        • Investigational Site Number : 1560001
      • Zhengzhou, Cina, 450008
        • Investigational Site Number : 1560003
  • Francia
      • Marseille, Francia, 13009
        • Investigational Site Number :2500002
      • Paris, Francia, 75010
        • Investigational Site Number :2500001
      • Paris, Francia, 75019
        • Investigational Site Number : 2500004
      • Villejuif, Francia, 94800
        • Investigational Site Number :2500003
  • Olanda
      • Amsterdam, Olanda, 1081 HV
        • Investigational Site Number :5280002
      • Groningen, Olanda, 9713 GZ
        • Investigational Site Number :5280003
      • Nijmegen, Olanda, 6525 GA
        • Investigational Site Number : 5280005
      • Rotterdam, Olanda, 3015 CE
        • Investigational Site Number :5280001
      • Utrecht, Olanda, 3584 CS
        • Investigational Site Number :5280004
  • Stati Uniti
    • California
      • Duarte, California, Stati Uniti, 91010
        • City of Hope-Site Number:8400002
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30303
        • Emory University School of Medicine- Grady Campus- Site Number : 8400006
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02215
        • Beth Israel Deaconess Medical Center-Site Number:8400004
    • New York
      • New York, New York, Stati Uniti, 10021
        • Weill Cornell Medical College-Site Number:8400003
      • The Bronx, New York, Stati Uniti, 10461
        • Montefiore Hutchinson Campus- Site Number : 8400012
    • Ohio
      • Columbus, Ohio, Stati Uniti, 43210
        • The Ohio State University- Site Number : 8400009
    • Oregon
      • Portland, Oregon, Stati Uniti, 97239
        • Oregon Health and Science University-Site Number:8400011
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • The Children's Hospital of Philadelphia- Site Number : 8400013
    • Texas
      • Houston, Texas, Stati Uniti, 77030
        • MD Anderson Cancer Center-Site Number:8400001
    • Washington
      • Seattle, Washington, Stati Uniti, 98105
        • Seattle Children's Hospital- Site Number : 8400014

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

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

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

- Il partecipante deve avere ≥12 anni al momento in cui il partecipante alla sperimentazione o il tutore legale firma il modulo di consenso informato.

Solo per i partecipanti alla Parte Escalation:

- Diagnosi confermata di LMA primaria o secondaria [qualsiasi sottotipo tranne la leucemia promielocitica acuta (APL)] secondo la classificazione dell'Organizzazione mondiale della sanità (OMS). I pazienti con AML devono soddisfare uno dei seguenti criteri, a), b) o c) e sono limitati a quelli per i quali non è disponibile (o non sono ammissibili) una terapia con beneficio clinico noto.

a) LMA da fallimento dell'induzione primaria (PIF), definita come malattia refrattaria a uno dei seguenti, i o ii.

i) Un tentativo intensivo di induzione, per istituto. I tentativi di induzione includono citarabina ad alto dosaggio e/o dosaggio standard ± antracicline/antracendione ± un anti-metabolita, con o senza fattore di crescita o regimi contenenti terapia mirata.

Gli esempi includono ma non sono limitati a:

  • Un ciclo di regime contenente citarabina ad alto dosaggio (HiDAC).
  • Un ciclo di citarabina liposomiale e daunorubicina

  • Due cicli di regime contenente citarabina a dose standard ii) Per adulti di età pari o superiore a 75 anni o con comorbidità che precludono l'uso di chemioterapia di induzione intensiva; La PIF è definita come AML refrattaria a uno dei seguenti regimi meno intensivi, 1 o 2:

    1. 4 cicli di agenti ipometilanti (HMA) o

    2. 2 cicli HMA + venetoclax b) AML a recidiva precoce (ER), definita come LMA in recidiva con durata CR < 6 mesi dal trattamento più recente c) Leucemia alla prima o più recidiva

      • Diagnosi confermata di cluster di differenziazione 123 (CD123) + HR-MDS, con una categoria di rischio IPSS-R (Revisioned International Prognostic Scoring System) di livello intermedio o superiore e sono limitati a quelli senza terapia disponibile (o non ammissibili) con clinica nota beneficio.
  • Non idoneo per la terapia di induzione e aver completato ≥2 cicli di uno qualsiasi dei seguenti: agente ipometilante (ad es. 5 azacitidina o decitabina) e/o venetoclax, chemioterapia o agenti mirati.

  • Non idoneo al trapianto autologo di cellule staminali (ASCT) e aver completato ≥1 ciclo di terapia di induzione.

    • Diagnosi confermata di CD123 + B-ALL senza lesioni extramidollari che non hanno una terapia disponibile (o non ammissibile) con beneficio clinico noto.

Solo per i partecipanti alla parte di espansione:

  • Per i partecipanti alla coorte A: partecipanti che soddisfano i criteri di inclusione per i pazienti con LMA che sono stati refrattari primari (PIF) a un precedente trattamento di induzione o che hanno avuto ER che si è verificato 6 mesi o meno dopo una remissione iniziale durante un precedente trattamento di induzione.
  • Per i partecipanti alla coorte B: partecipanti che soddisfano i criteri di inclusione per i pazienti con LMA che hanno avuto una recidiva tardiva (LR), verificatasi più di 6 mesi dopo una remissione iniziale durante il precedente trattamento di induzione.
  • Peso corporeo >40 kg. -- Peso corporeo >40 kg. - - -

Criteri di esclusione:

  • Performance status dell'Eastern Cooperative Oncology Group (ECOG) >2 (≥18 anni). Scala Karnovsky (16-17 anni)
  • Storia di una condizione autoimmune attiva o cronica che ha richiesto o richiede terapia.
  • Secondo tumore maligno primario che richiede una terapia attiva. È consentita la terapia ormonale adiuvante.
  • Evidenza di leucemia attiva del sistema nervoso centrale al momento dell'arruolamento, come evidenziato dalla citologia o dalla patologia.
  • Sindrome da immunodeficienza acquisita nota (malattie correlate all'AIDS) o malattia da virus dell'immunodeficienza umana (HIV) che richiede un trattamento antiretrovirale o con infezione attiva da epatite B o C o infezione da sindrome respiratoria acuta grave da coronavirus 2 (SARS-CoV-2). I partecipanti con una storia di infezione da SARS-CoV-2 devono aver completato il recupero clinico almeno 1 mese prima dell'arruolamento. - Precedente trattamento con un agente diretto anti-CD123.
  • Un precedente HSCT con recidiva oltre i 3 mesi può essere incluso solo se l'immunosoppressione non è stata eseguita per un minimo di 4 settimane e nessuna evidenza di malattia del trapianto contro l'ospite (GVHD).
  • Ricevere al momento della prima somministrazione del medicinale sperimentale (IMP) corticosteroidi come farmaco concomitante con una dose di corticosteroidi > 10 mg/giorno di prednisone orale o equivalente,
  • Precedente trattamento con terapia cellulare, ad es. Cellule T del recettore dell'antigene chimerico (CAR-T) o cellule NK del recettore dell'antigene chimerico (CAR-NK).
  • Trattamento concomitante con altri farmaci sperimentali.
  • La radioterapia, anche se con intento palliativo, non può essere somministrata durante lo studio.
  • Uso profilattico di fattori di crescita ematopoietici (p. es., fattore stimolante le colonie di granulociti (G-CSF), fattore stimolante le colonie di granulociti-macrofagi (GM-CSF), eritropoietina) durante il periodo di osservazione della DLT solo nella Parte di aumento della dose. - Soggetti alloggiati in un istituto a causa di un ordinamento normativo o legale; detenuti o partecipanti legalmente istituzionalizzati.
  • Donne in gravidanza e allattamento.
  • Storia di trapianto di organi solidi, compreso il trapianto di cornea.
  • QTc medio (utilizzando il calcolo della correzione Fridericia) >470 millisecondi (msec) allo screening.

Le informazioni di cui sopra non intendono contenere tutte le considerazioni rilevanti per una potenziale partecipazione a una sperimentazione clinica.

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 di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: SAR443579

Aumento della dose: SAR443579 somministrato per via endovenosa a livelli di dose crescenti.

Espansione della dose: SAR443579 somministrato per via endovenosa alla dose raccomandata e al programma determinato dall'aumento della dose.
Droga: SAR443579
Polvere per soluzione per infusione; per infusione endovenosa

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
Lasso di tempo: Cycle 1 Day 1 up to Cycle 1 Day 28. Each cycle duration in induction period was 28 days.
The DLT was defined as any of the following events during Cycle 1 (first 28 days) using NCI CTCAE v5.0 or ASTCT criteria, whether related or not to the study treatment in the absence of clear evidence to the contrary, and if not related to disease progression. Hematologic DLTs included hematologic toxicities, bone marrow hypocellularity, decreased neutrophils lasting, febrile neutropenia, decreased platelet count lasting, anemia (all Grade 4), and Grade 3 thrombocytopenia. Non-hematologic DLTs included any Grade >=3 toxicities except alopecia, Grade 3 fatigue, asthenia, fever, anorexia, constipation, nausea, vomiting, diarrhea, total parenteral nutrition, hospitalization related events, infection, bleeding, Grade 3 infusion related reaction and laboratory abnormalities, Grade 3 or 4 tumor lysis syndrome and isolated electrolyte abnormalities. Also, DLTs were any treatment related toxicity causing >2 week delay in recovery to baseline/Grade <=1 or requiring dose reduction.
Cycle 1 Day 1 up to Cycle 1 Day 28. Each cycle duration in induction period was 28 days.
Dose Escalation (Cohort C): Number of Participants With Dose Limiting Toxicities
Lasso di tempo: Cycle 1 Day 1 to Cycle 1 Day 28. Each cycle duration in induction period was 28 days.
The DLT was defined as any of the following events during Cycle 1 (first 28 days) using NCI CTCAE v5.0 or ASTCT criteria, whether related or not to the study treatment in the absence of clear evidence to the contrary, and if not related to disease progression. Hematologic DLTs included hematologic toxicities, bone marrow hypocellularity, decreased neutrophils lasting, febrile neutropenia, decreased platelet count lasting, anemia (all Grade 4), and Grade 3 thrombocytopenia. Non-hematologic DLTs included any Grade >=3 toxicities except alopecia, Grade 3 fatigue, asthenia, fever, anorexia, constipation, nausea, vomiting, diarrhea, total parenteral nutrition, hospitalization related events, infection, bleeding, Grade 3 infusion related reaction and laboratory abnormalities, Grade 3 or 4 tumor lysis syndrome and isolated electrolyte abnormalities. Also, DLTs were any treatment related toxicity causing >2 week delay in recovery to baseline/Grade <=1 or requiring dose reduction.
Cycle 1 Day 1 to Cycle 1 Day 28. Each cycle duration in induction period was 28 days.
Dose Expansion (Cohorts A1, A2 and D): Composite Complete Remission (CRc) Rate
Lasso di tempo: Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
The CRc rate was defined as the percentage of participants who had a response of complete remission (CR), CR with partial hematologic recovery (CRh) or CR with incomplete hematologic recovery (CRi) according to modified AML International Working Group (IWG) 2003 response criteria.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
Dose Expansion (Cohort B): Overall Response Rate (ORR)
Lasso di tempo: Tumors were planned to assess on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first.
The ORR was defined as the percentage of participants who had a response of CR, CR equivalent, partial remission (PR), CR with limited count recovery (CRL), CRh or hematologic improvement (HI) according to IWG 2023 myelodysplastic syndrome (MDS) response criteria.
Tumors were planned to assess on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Dose Expansion (Cohorts A1, A2, B and D): Recommended Dose for Expansion (RDE)
Lasso di tempo: Cycle 1 Day 1 up to Cycle 1 Day 28. Each cycle duration in induction period was 28 days.
The RDE of SAR443579 was determined based on the occurrence of DLTs in Cycle 1.
Cycle 1 Day 1 up to Cycle 1 Day 28. Each cycle duration in induction period was 28 days.
Dose Escalation and Dose Expansion (Cohort A1): Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)
Lasso di tempo: From the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation (adult), 12 weeks for dose escalation (pediatric) and 20.9 for dose expansion (Cohort A1).
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any AE that: resulted in death; or was life-threatening; or required inpatient hospitalization or prolongation of existing hospitalization; or resulted in persistent or significant disability/incapacity; or was a congenital anomaly/birth defect; or was an important medical event. The TEAEs were defined as events that were newly reported or reported to worsen in severity after the first administration of study treatment up to 30 days after the last administration of study treatment.
From the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation (adult), 12 weeks for dose escalation (pediatric) and 20.9 for dose expansion (Cohort A1).
Dose Escalation and Dose Expansion (Cohort A1): Minimum Plasma Concentration (Ctrough) of SAR443579
Lasso di tempo: At Days 1, 4, 8, 11, 15, 22, and 28 of Cycle 1
Blood samples are collected just before treatment administration during repeated dosing to determine the Ctrough of SAR443579.
At Days 1, 4, 8, 11, 15, 22, and 28 of Cycle 1
Dose Escalation and Dose Expansion (Cohort A1): Percentage of Participants With Anti-drug Antibodies (ADA) Against SAR443579
Lasso di tempo: From the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation (adult), 12 weeks for dose escalation (pediatric) and 20.9 for dose expansion (Cohort A1).
Plasma samples were collected to assess the antibodies to SAR443579. Treatment-emergent ADA was defined as a participant with at least 1 treatment-induced or treatment-boosted ADA-positive sample at any time during the treatment or follow-up observation period. Non-treatment emergent ADA was defined as participant without any treatment-induced, treatment-boosted ADA-positive or ADA-inconclusive sample during the treatment or follow-up observation period.
From the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation (adult), 12 weeks for dose escalation (pediatric) and 20.9 for dose expansion (Cohort A1).
Dose Escalation and Dose Expansion (Cohort C): Composite Complete Remission Rate Assessed by Acute Myeloid Leukemia 2003 Modified International Working Group Response Criteria and National Comprehensive Cancer Network (NCCN)
Lasso di tempo: Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapse, unacceptable AE, discontinuation or death. Maximum treatment duration: 117.3 weeks (adults) and 12 weeks (pediatrics) in dose escalation phase.
The CRc rate was defined as the percentage of participants who had a response of CR, CRh or CRi according to modified AML IWG 2003 response criteria. For Dose Expansion (Cohort C), the CRc rate was planned to be assessed according to NCCN.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapse, unacceptable AE, discontinuation or death. Maximum treatment duration: 117.3 weeks (adults) and 12 weeks (pediatrics) in dose escalation phase.
Dose Escalation and Dose Expansion (Cohort C): Alternative Complete Remission Rate
Lasso di tempo: Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapse, unacceptable AE, discontinuation or death. Maximum treatment duration: 117.3 weeks (adults) and 12 weeks (pediatrics) in dose escalation phase.
Alternative CR rate was defined as percentage of participants with CR and CRh according to modified AML IWG 2003 response criteria.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapse, unacceptable AE, discontinuation or death. Maximum treatment duration: 117.3 weeks (adults) and 12 weeks (pediatrics) in dose escalation phase.
Dose Escalation and Dose Expansion (Cohort C): Overall Response Rate
Lasso di tempo: Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapse, unacceptable AE, discontinuation or death. Maximum treatment duration: 117.3 weeks (adults) and 12 weeks (pediatrics) in dose escalation phase.
Overall response rate was defined as percentage of participants who had a CR or CRi or CRh or PR or morphological leukemia-free state (MLFS) according to modified AML IWG 2003 response criteria.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapse, unacceptable AE, discontinuation or death. Maximum treatment duration: 117.3 weeks (adults) and 12 weeks (pediatrics) in dose escalation phase.
Dose Expansion (Cohorts A1, A2 and D): Overall Response Rate
Lasso di tempo: Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
Overall response rate was defined as percentage of participants who had a CR or CRi or CRh or PR or MLFS according to modified AML IWG 2003 response criteria.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
Dose Expansion (Cohorts A1, A2 and D): Duration of Composite Complete Remission Rate
Lasso di tempo: Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
Duration of CRc was defined as the time interval from first documented evidence of CRc (CR, CRh or CRi) until disease relapse (DR) or death due to any cause, whichever comes first.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
Dose Expansion (Cohorts A1, A2, B and D): Duration of Overall Response Rate
Lasso di tempo: Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
Duration of overall response rate was defined as the time from the first documented evidence of CR or CRi or CRh or PR or MLFS until DR or death due to any cause, whichever comes first.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
Dose Expansion (Cohorts A1, A2, B and D): Alternative Complete Remission Rate
Lasso di tempo: Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
Alternative CR rate was defined as percentage of participants with CR and CRh according to modified AML IWG 2003 response criteria.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
Dose Expansion (Cohorts A1, A2, B and D): Duration of Alternative Complete Remission Rate
Lasso di tempo: Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
Duration of alternative CR was defined as the time from the first documented evidence of CR or CRh until DR or death due to any cause, whichever comes first.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
Dose Expansion (Cohorts A1, A2, B and D): Event-Free Survival (EFS)
Lasso di tempo: Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
The EFS was defined as the time interval from the first day of treatment assignment to the date of earliest evidence of relapse, treatment failure, or death.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
Dose Expansion (Cohorts A1, A2, B and D): Overall Survival (OS)
Lasso di tempo: Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
The OS was defined as time interval from the first day of treatment assignment to death from any cause.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
Dose Expansion (Cohorts A1, A2, B and D): Rate of Hematopoietic Stem Cell Transplantation (HSCT)
Lasso di tempo: Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
The HSCT rate was defined as the percentage of participants who had received HSCT immediately following study treatment administration but prior to subsequent therapy for treatment of AML.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
Dose Expansion (Cohorts A1, A2, B and D): Time to Treatment Failure (TTF)
Lasso di tempo: Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
The TTF was defined as the time from first day of treatment assignment to discontinuation for any reason excluding remission, example, relapsed disease, refractory disease, unacceptable AE, participant preference or death.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
Dose Expansion (Cohorts A1, A2 and D): Transfusion Independence (TI) Rate
Lasso di tempo: Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
The TI rate was defined differently for participants who were transfusion dependency (TD) at baseline and participants who were transfusion independency (TI) at baseline. For subgroup of participants with TD at baseline, the TI rate was defined as the percentage of participants who convert from baseline TD to TI during on treatment period; For subgroup of participants with TI at baseline, the TI rate was defined as the percentage of participants who remain TI during 56-day post baseline period during treatment.
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.
Dose Expansion (Cohort B): Progression Free Survival (PFS)
Lasso di tempo: Tumors were planned to assess on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first.
The PFS was defined as the time interval from the first day of treatment assignment to the date of disease progression, relapse from CR (or CR equivalent), PR, CRL, CRh, or HI, death due to any cause, whichever comes first.
Tumors were planned to assess on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first.

Collaboratori e investigatori

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

Sponsor

Sanofi

Investigatori

  • Direttore dello studio: Clinical Sciences & Operations, Sanofi

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.

Collegamenti utili

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)

8 dicembre 2021

Completamento primario (Effettivo)

13 giugno 2025

Completamento dello studio (Effettivo)

13 giugno 2025

Date di iscrizione allo studio

Primo inviato

19 ottobre 2021

Primo inviato che soddisfa i criteri di controllo qualità

19 ottobre 2021

Primo Inserito (Effettivo)

20 ottobre 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TCD17197
  • U1111-1266-7399 (Identificatore di registro: ICTRP)
  • 2021-004287-98 (Numero EudraCT)
  • 2023-508357-58 (Identificatore di registro: CTIS)

Piano per i dati dei singoli partecipanti (IPD)

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

SÌ

Descrizione del piano IPD

I ricercatori qualificati possono richiedere l'accesso ai dati a livello di paziente e ai relativi documenti di studio, tra cui il rapporto dello studio clinico, il protocollo dello studio con eventuali modifiche, il modulo di segnalazione del caso in bianco, il piano di analisi statistica e le specifiche del set di dati. I dati a livello di paziente saranno resi anonimi e i documenti dello studio saranno redatti per proteggere la privacy dei partecipanti allo studio. Ulteriori dettagli sui criteri di condivisione dei dati di Sanofi, sugli studi ammissibili e sulla procedura per richiedere l'accesso sono disponibili all'indirizzo: https://vivli.org

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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