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Første-i-menneske-undersøgelse af SAR443579-infusion hos mandlige og kvindelige deltagere på mindst 12 år med recidiverende eller refraktær akut myeloid leukæmi (R/R AML), B-celle akut lymfatisk leukæmi (B-ALL) eller højrisiko- myelodysplasi (HR-MDS)

8. juni 2026 opdateret af: Sanofi

En åben-label, første-i-menneske, dosis-eskaleringsundersøgelse af SAR443579 administreret som enkeltstof ved intravenøs infusion hos patienter med recidiverende eller refraktær akut myeloid leukæmi (R/R AML), B-celle akut lymfoblastisk leukæmi (B-ALL) ) eller højrisiko-myelodysplasi (HR-MDS)

Dette er et åbent, multicenter, fase 1/fase 2, dosiseskalering og dosisudvidelsesundersøgelse for at evaluere sikkerheden, farmakokinetik, farmakodynamik og anti-leukæmisk aktivitet af SAR443579 i forskellige hæmatologiske maligniteter.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

2,5 år.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

101

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

- Deltageren skal være ≥12 år gammel på det tidspunkt, hvor forsøgsdeltageren eller værgen underskriver den informerede samtykkeformular.

Kun for deltagere i eskaleringsdelen:

- Bekræftet diagnose af primær eller sekundær AML [enhver undertype undtagen akut promyelocytisk leukæmi (APL)] i henhold til Verdenssundhedsorganisationens (WHO) klassifikation. Patienter med AML skal opfylde et af følgende kriterier, a), b) eller c) og er begrænset til dem, der ikke har nogen tilgængelig (eller ikke kvalificeret) behandling med kendte kliniske fordele.

a) Primær induktionssvigt (PIF) AML, defineret som sygdomsrefraktær over for en af ​​følgende, i eller ii.

i) Et intensivt introduktionsforsøg pr. institution. Induktionsforsøg omfatter højdosis og/eller standarddosis cytarabin ± en anthracycliner/antracendion ± en anti-metabolit, med eller uden vækstfaktor eller målrettet behandling indeholdende regimer.

Eksempler omfatter, men er ikke begrænset til:

  • Én cyklus med høj dosis cytarabin (HiDAC) indeholdende regime
  • En cyklus af liposomalt cytarabin og daunorubicin

  • To cyklusser med standarddosis cytarabinholdigt regime ii) Til voksne, der er 75 år eller ældre, eller som har komorbiditeter, der udelukker brug af intensiv induktionskemoterapi; PIF er defineret som AML-refraktær over for en af ​​følgende mindre intensive regimer, 1 eller 2:

    1. 4 cyklusser af hypomethylerende midler (HMA) eller

    2. 2 cyklusser HMA + venetoclax b) Tidligt tilbagefald (ER) AML, defineret som AML i tilbagefald med CR-varighed < 6 måneder fra seneste behandling c) Leukæmi ved første eller højere tilbagefald

      • Bekræftet diagnose af cluster of differentiation 123 (CD123) + HR-MDS, med en Revised International Prognostic Scoring System (IPSS-R) risikokategori af intermediær eller højere og er begrænset til dem uden tilgængelig (eller er ikke-kvalificeret) behandling med kendt klinisk fordel.
  • Ikke kvalificeret til induktionsterapi og har gennemført ≥2 cyklusser af et eller flere af følgende: hypomethylerende middel (f.eks. 5 azacitidin eller decitabin) og/eller venetoclax, kemoterapi eller målrettede midler.

  • Ikke kvalificeret til autolog stamcelletransplantation (ASCT) og har gennemført ≥1 forløb med induktionsterapi.

    • Bekræftet diagnose af CD123 + B-ALL uden ekstramedullære læsioner, der ikke har nogen tilgængelig (eller ikke kvalificeret) behandling med kendt klinisk fordel.

Kun for deltagere i udvidelsesdelen:

  • For deltagere i kohorte A: Deltagere, der opfylder inklusionskriterier for AML-patienter, der har været primært refraktære (PIF) over for tidligere induktionsbehandling, eller som har haft ER opstået 6 måneder eller mindre efter en indledende remission på tidligere induktionsbehandling.
  • For deltagere i kohorte B: Deltagere, der opfylder inklusionskriterier for AML-patienter, der har haft sent tilbagefald (LR), opstået mere end 6 måneder efter en indledende remission på tidligere induktionsbehandling.
  • Kropsvægt >40 kg. -- Kropsvægt >40 kg. -- -

Ekskluderingskriterier:

  • Eastern Cooperative Oncology Group (ECOG) præstationsstatus >2 (≥18 år gammel). Karnovsky-skalaen (16-17 år)
  • Anamnese med en aktiv eller kronisk autoimmun tilstand, der har krævet eller kræver behandling.
  • Anden primær malignitet, der kræver aktiv terapi. Adjuverende hormonbehandling er tilladt.
  • Bevis på aktiv leukæmi i centralnervesystemet på tidspunktet for indskrivningen, som påvist af cytologi eller patologi.
  • Kendt erhvervet immundefektsyndrom (AIDS-relaterede sygdomme) eller human immundefektvirus (HIV) sygdom, der kræver antiretroviral behandling, eller har aktiv hepatitis B eller C infektion eller alvorlig akut respiratorisk syndrom coronavirus 2 (SARS-CoV-2) infektion. Deltagere med en historie med SARS-CoV-2-infektion skal have afsluttet klinisk restitution mindst 1 måned før tilmelding. - Forudgående behandling med et anti-CD123-rettet middel.
  • Tidligere HSCT med tilbagefald ud over 3 måneder kan kun inkluderes, hvis immunosuppression er afbrudt i minimum 4 uger og ingen tegn på graft versus host sygdom (GVHD).
  • Modtagelse på tidspunktet for første forsøgslægemiddel (IMP) administration kortikosteroid som en samtidig medicin med kortikosteroiddosis >10 mg/dag af oral prednison eller tilsvarende,
  • Forudgående behandling med cellulær terapi, f.eks. kimær antigenreceptor T-celle (CAR-T) eller kimær antigenreceptor NK-celle (CAR-NK).
  • Samtidig behandling med andre forsøgslægemidler.
  • Strålebehandling, selvom den er palliativ i hensigten, kan ikke gives under undersøgelsen.
  • Profylaktisk brug af hæmatopoietiske vækstfaktorer (f.eks. granulocyt-koloni-stimulerende faktor (G-CSF), granulocyt-makrofage-koloni-stimulerende faktor (GM-CSF), erythropoietin) under DLT-observationsperioden kun i dosiseskaleringsdelen. - Personer, der er indkvarteret i en institution på grund af lovgivningsmæssig eller juridisk orden; fanger eller deltagere, der er lovligt institutionaliserede.
  • Gravide og ammende kvinder.
  • Historie om solid organtransplantation, herunder hornhindetransplantation.
  • Gennemsnitlig QTc (ved hjælp af Fridericia-korrektionsberegningen) >470 millisekund (msec) ved screening.

Ovenstående information er ikke beregnet til at indeholde alle overvejelser, der er relevante for en potentiel deltagelse i et klinisk forsøg.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: SAR443579

Dosiseskalering: SAR443579 administreret intravenøst ​​ved eskalerende dosisniveauer.

Dosisudvidelse: SAR443579 administreret intravenøst ​​i den anbefalede dosis og tidsplan bestemt ud fra dosiseskaleringen.
Medicin: SAR443579
Pulver til opløsning til infusion; ved IV-infusion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dose Expansion (Cohorts A1, A2, B and D): Recommended Dose for Expansion (RDE)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sanofi

Efterforskere

  • Studieleder: Clinical Sciences & Operations, Sanofi

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. december 2021

Primær færdiggørelse (Faktiske)

13. juni 2025

Studieafslutning (Faktiske)

13. juni 2025

Datoer for studieregistrering

Først indsendt

19. oktober 2021

Først indsendt, der opfyldte QC-kriterier

19. oktober 2021

Først opslået (Faktiske)

20. oktober 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TCD17197
  • U1111-1266-7399 (Registry Identifier: ICTRP)
  • 2021-004287-98 (EudraCT nummer)
  • 2023-508357-58 (Registry Identifier: CTIS)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Kvalificerede forskere kan anmode om adgang til data på patientniveau og relaterede undersøgelsesdokumenter, herunder den kliniske undersøgelsesrapport, undersøgelsesprotokol med eventuelle ændringer, blank case-rapportformular, statistisk analyseplan og datasætspecifikationer. Data på patientniveau vil blive anonymiseret, og undersøgelsesdokumenter vil blive redigeret for at beskytte forsøgsdeltagernes privatliv. Yderligere detaljer om Sanofis kriterier for datadeling, kvalificerede undersøgelser og proces for at anmode om adgang kan findes på: https://vivli.org

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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