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Första-i-människ-studie av SAR443579-infusion hos manliga och kvinnliga deltagare i minst 12 års ålder med återfall eller refraktär akut myeloisk leukemi (R/R AML), akut lymfatisk B-cell leukemi (B-ALL) eller högrisk- myelodysplasi (HR-MDS)

8 juni 2026 uppdaterad av: Sanofi

En öppen, först i människa, dosökningsstudie av SAR443579 administrerat som enskilt medel genom intravenös infusion hos patienter med återfall eller refraktär akut myeloisk leukemi (R/R AML), akut lymfoblastisk leukemi av B-celler (B-ALL) ) eller högrisk-myelodysplasi (HR-MDS)

Detta är en öppen, multicenter, fas 1/fas 2, dosökning och dosökningsstudie för att utvärdera säkerheten, farmakokinetiken, farmakodynamiken och den antileukemiska aktiviteten hos SAR443579 vid olika hematologiska maligniteter.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

2,5 år.

Studietyp

Interventionell

Inskrivning (Faktisk)

101

Fas

  • Fas 2
  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

12 år och äldre (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Beskrivning

Inklusionskriterier:

- Deltagaren måste vara ≥12 år vid den tidpunkt då provdeltagaren eller vårdnadshavare undertecknar formuläret för informerat samtycke.

Endast för deltagare i eskaleringsdelen:

- Bekräftad diagnos av primär eller sekundär AML [alla undertyper utom akut promyelocytisk leukemi (APL)] enligt klassificeringen från Världshälsoorganisationen (WHO). Patienter med AML måste uppfylla ett av följande kriterier, a), b) eller c) och är begränsade till de som inte har någon tillgänglig (eller inte är kvalificerad) behandling med känd klinisk nytta.

a) Primary Induction Failure (PIF) AML, definierad som sjukdomsrefraktär mot något av följande, i eller ii.

i) Ett intensivt introduktionsförsök per institution. Induktionsförsök inkluderar högdos och/eller standarddos cytarabin ± en antracykliner/antracenedion ± en antimetabolit, med eller utan tillväxtfaktor eller riktade behandlingsinnehållande regimer.

Exempel inkluderar men är inte begränsade till:

  • En cykel med högdos cytarabin (HiDAC) innehållande regim
  • En cykel av liposomalt cytarabin och daunorubicin

  • Två cykler av standarddosbehandling med cytarabin ii) För vuxna som är 75 år eller äldre, eller som har komorbiditeter som utesluter användning av intensiv induktionskemoterapi; PIF definieras som AML-refraktär mot en av följande mindre intensiva kurer, 1 eller 2:

    1. 4 cykler av hypometyleringsmedel (HMA) eller

    2. 2 cykler HMA + venetoclax b) Tidiga återfall (ER) AML, definieras som AML i återfall med CR-duration < 6 månader från senaste behandling c) Leukemi i första eller högre skov

      • Bekräftad diagnos av differentieringskluster 123 (CD123) + HR-MDS, med ett Revised International Prognostic Scoring System (IPSS-R) riskkategori av intermediär eller högre och är begränsade till de som inte har någon tillgänglig (eller är olämplig) terapi med känd klinisk dra nytta.
  • Inte kvalificerad för induktionsterapi och har genomfört ≥2 cykler av något av följande: hypometylerande medel (t.ex. 5 azacitidin eller decitabin) och/eller venetoclax, kemoterapi eller målinriktade medel.

  • Ej kvalificerad för autolog stamcellstransplantation (ASCT) och har genomfört ≥1 induktionsbehandlingskur.

    • Bekräftad diagnos av CD123 + B-ALL utan extramedullära lesioner som inte har någon tillgänglig (eller är olämplig) behandling med känd klinisk nytta.

Endast för deltagare i expansionsdelen:

  • För deltagare i kohort A: Deltagare som uppfyller inklusionskriterierna för AML-patienter som har varit primära refraktära (PIF) mot tidigare induktionsbehandling eller som har haft ER som inträffat 6 månader eller mindre efter en initial remission vid tidigare induktionsbehandling.
  • För deltagare i kohort B: Deltagare som uppfyller inklusionskriterierna för AML-patienter som har haft sent återfall (LR), som inträffar mer än 6 månader efter en initial remission vid tidigare induktionsbehandling.
  • Kroppsvikt >40 kg. -- Kroppsvikt >40 kg. -- -

Exklusions kriterier:

  • Eastern Cooperative Oncology Group (ECOG) prestationsstatus >2 (≥18 år gammal). Karnovsky-skalan (16-17 år)
  • Historik om ett aktivt eller kroniskt autoimmunt tillstånd som har krävt eller kräver behandling.
  • Andra primär malignitet som kräver aktiv terapi. Adjuvant hormonbehandling är tillåten.
  • Bevis på aktiv leukemi i centrala nervsystemet vid tidpunkten för inskrivningen, vilket framgår av cytologi eller patologi.
  • Känt förvärvat immunbristsyndrom (AIDS-relaterade sjukdomar) eller humant immunbristvirus (HIV) sjukdom som kräver antiretroviral behandling, eller som har aktiv hepatit B- eller C-infektion, eller allvarligt akut respiratoriskt syndrom coronavirus 2 (SARS-CoV-2)-infektion. Deltagare med en historia av SARS-CoV-2-infektion måste ha avslutat kliniskt tillfrisknande minst 1 månad före inskrivningen. - Tidigare behandling med ett anti-CD123-riktat medel.
  • Tidigare HSCT med återfall längre än 3 månader kan endast inkluderas om immunsuppression är avstängd i minst 4 veckor och inga tecken på graft versus host disease (GVHD).
  • Får vid tidpunkten för första prövningsläkemedlet (IMP) administrering kortikosteroid som en samtidig medicinering med kortikosteroiddos >10 mg/dag av oral prednison eller motsvarande,
  • Tidigare behandling med cellulär terapi, t.ex. chimär antigenreceptor T-cell (CAR-T) eller chimär antigenreceptor NK-cell (CAR-NK).
  • Samtidig behandling med andra prövningsläkemedel.
  • Strålbehandling, även om palliativ avsikt är, kanske inte ges under studien.
  • Profylaktisk användning av hematopoetiska tillväxtfaktorer (t.ex. granulocyt-kolonistimulerande faktor (G-CSF), granulocyt-makrofagkolonistimulerande faktor (GM-CSF), erytropoietin) under DLT-observationsperioden endast i dosupptrappningsdelen. - Individer som är inkvarterade på en institution på grund av reglering eller rättsordning; fångar eller deltagare som är juridiskt institutionaliserade.
  • Gravida och ammande kvinnor.
  • Historik av solida organtransplantationer, inklusive hornhinnetransplantation.
  • Genomsnittlig QTc (med Fridericia-korrigeringsberäkningen) >470 millisekund (ms) vid screening.

Ovanstående information är inte avsedd att innehålla alla överväganden som är relevanta för ett potentiellt deltagande i en klinisk prövning.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: SAR443579

Dosökning: SAR443579 administreras intravenöst vid stigande dosnivåer.

Dosexpansion: SAR443579 administreras intravenöst i den rekommenderade dosen och schemat som bestämts utifrån dosökningen.
Läkemedel: SAR443579
Pulver till infusionsvätska, lösning; genom IV-infusion

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Dose Expansion (Cohorts A1, A2, B and D): Recommended Dose for Expansion (RDE)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Sanofi

Utredare

  • Studierektor: Clinical Sciences & Operations, Sanofi

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

8 december 2021

Primärt slutförande (Faktisk)

13 juni 2025

Avslutad studie (Faktisk)

13 juni 2025

Studieregistreringsdatum

Först inskickad

19 oktober 2021

Först inskickad som uppfyllde QC-kriterierna

19 oktober 2021

Första postat (Faktisk)

20 oktober 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Kvalificerade forskare kan begära tillgång till patientnivådata och relaterade studiedokument inklusive den kliniska studierapporten, studieprotokollet med eventuella ändringar, blankt fallrapportformulär, statistisk analysplan och datauppsättningsspecifikationer. Data på patientnivå kommer att anonymiseras och studiedokument kommer att redigeras för att skydda försöksdeltagarnas integritet. Ytterligare information om Sanofis kriterier för datadelning, kvalificerade studier och process för att begära åtkomst finns på: https://vivli.org

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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