Første-i-menneske-studie av SAR443579-infusjon hos mannlige og kvinnelige deltakere på minst 12 år med tilbakefall eller refraktær akutt myeloisk leukemi (R/R AML), akutt B-celle lymfatisk leukemi (B-ALL) eller høyrisiko- myelodysplasi (HR-MDS)
8. juni 2026 oppdatert av: Sanofi
En åpen, første-i-menneske, doseeskaleringsstudie av SAR443579 administrert som enkeltmiddel ved intravenøs infusjon hos pasienter med residiverende eller refraktær akutt myeloisk leukemi (R/R AML), B-celle akutt lymfoblastisk leukemi (B-ALL) ) eller høyrisiko-myelodysplasi (HR-MDS)
Dette er en åpen, multisenter, fase 1/fase 2, doseøknings- og doseutvidelsesstudie for å evaluere sikkerheten, farmakokinetikken, farmakodynamikken og den anti-leukemiske aktiviteten til SAR443579 ved ulike hematologiske maligniteter.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
2,5 år.
Studietype
Intervensjonell
Registrering (Faktiske)
101
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Victoria
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Melbourne, Victoria, Australia, 3000
- Investigational Site Number :0360002
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Melbourne, Victoria, Australia, 3004
- Investigational Site Number :0360001
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California
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Duarte, California, Forente stater, 91010
- City of Hope-Site Number:8400002
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Georgia
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Atlanta, Georgia, Forente stater, 30303
- Emory University School of Medicine- Grady Campus- Site Number : 8400006
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
- Beth Israel Deaconess Medical Center-Site Number:8400004
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New York
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New York, New York, Forente stater, 10021
- Weill Cornell Medical College-Site Number:8400003
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The Bronx, New York, Forente stater, 10461
- Montefiore Hutchinson Campus- Site Number : 8400012
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Ohio
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Columbus, Ohio, Forente stater, 43210
- The Ohio State University- Site Number : 8400009
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Oregon
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Portland, Oregon, Forente stater, 97239
- Oregon Health and Science University-Site Number:8400011
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- The Children's Hospital of Philadelphia- Site Number : 8400013
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Texas
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Houston, Texas, Forente stater, 77030
- MD Anderson Cancer Center-Site Number:8400001
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Washington
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Seattle, Washington, Forente stater, 98105
- Seattle Children's Hospital- Site Number : 8400014
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Marseille, Frankrike, 13009
- Investigational Site Number :2500002
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Paris, Frankrike, 75010
- Investigational Site Number :2500001
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Paris, Frankrike, 75019
- Investigational Site Number : 2500004
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Villejuif, Frankrike, 94800
- Investigational Site Number :2500003
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Tianjin, Kina, 300020
- Investigational Site Number : 1560001
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Zhengzhou, Kina, 450008
- Investigational Site Number : 1560003
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Amsterdam, Nederland, 1081 HV
- Investigational Site Number :5280002
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Groningen, Nederland, 9713 GZ
- Investigational Site Number :5280003
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Nijmegen, Nederland, 6525 GA
- Investigational Site Number : 5280005
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Rotterdam, Nederland, 3015 CE
- Investigational Site Number :5280001
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Utrecht, Nederland, 3584 CS
- Investigational Site Number :5280004
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
12 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier:
- Deltakeren må være ≥12 år på det tidspunktet prøvedeltakeren eller den juridiske foresatte signerer skjemaet for informert samtykke.
Kun for deltakere i eskaleringsdelen:
- Bekreftet diagnose av primær eller sekundær AML [enhver undertype unntatt akutt promyelocytisk leukemi (APL)] i henhold til Verdens helseorganisasjon (WHO) klassifisering. Pasienter med AML må oppfylle ett av følgende kriterier, a), b) eller c) og er begrenset til de som ikke har tilgjengelig (eller ikke er kvalifisert) behandling med kjent klinisk fordel.
a) Primær induksjonssvikt (PIF) AML, definert som sykdomsrefraktær overfor ett av følgende, i eller ii.
i) Et intensivt introduksjonsforsøk, per institusjon. Induksjonsforsøk inkluderer høydose og/eller standarddose cytarabin ± en antracykliner/antracenedion ± en antimetabolitt, med eller uten vekstfaktor eller målrettet behandling som inneholder regimer.
Eksempler inkluderer, men er ikke begrenset til:
- Én syklus med kur som inneholder høy dose cytarabin (HiDAC).
- En syklus med liposomalt cytarabin og daunorubicin
To sykluser med standarddose som inneholder cytarabin ii) For voksne som er 75 år eller eldre, eller som har komorbiditeter som utelukker bruk av intensiv induksjonskjemoterapi; PIF er definert som AML-refraktær overfor ett av følgende mindre intensive regimer, 1 eller 2:
- 4 sykluser med hypometylerende midler (HMA) eller
2 sykluser HMA + venetoclax b) Tidlig tilbakefall (ER) AML, definert som AML i tilbakefall med CR-varighet < 6 måneder fra siste behandling c) Leukemi ved første eller høyere tilbakefall
- Bekreftet diagnose av cluster of differentiation 123 (CD123) + HR-MDS, med en Revised International Prognostic Scoring System (IPSS-R) risikokategori av middels eller høyere og er begrenset til de som ikke har tilgjengelig (eller er ikke kvalifisert) terapi med kjent klinisk fordel.
- Ikke kvalifisert for induksjonsterapi og har fullført ≥2 sykluser av noen av følgende: hypometylerende middel (f.eks. 5 azacitidin eller decitabin) og/eller venetoklaks, kjemoterapi eller målrettede midler.
Ikke kvalifisert for autolog stamcelletransplantasjon (ASCT) og har fullført ≥1 kur med induksjonsterapi.
- Bekreftet diagnose av CD123 + B-ALL uten ekstramedullære lesjoner som ikke har noen tilgjengelig (eller ikke er kvalifisert) behandling med kjent klinisk fordel.
Kun for deltakere i utvidelsesdelen:
- For deltakere i kohort A: Deltakere som oppfyller inklusjonskriteriene for AML-pasienter som har vært primært refraktære (PIF) til tidligere induksjonsbehandling eller som har hatt ER oppstått 6 måneder eller mindre etter en innledende remisjon ved tidligere induksjonsbehandling.
- For deltakere i kohort B: Deltakere som oppfyller inklusjonskriteriene for AML-pasienter som har hatt sent tilbakefall (LR), som oppstår mer enn 6 måneder etter en første remisjon ved tidligere induksjonsbehandling.
- Kroppsvekt >40 kg. -- Kroppsvekt >40 kg. -- -
Ekskluderingskriterier:
- Eastern Cooperative Oncology Group (ECOG) ytelsesstatus >2 (≥18 år gammel). Karnovsky-skala (16-17 år)
- Historie om en aktiv eller kronisk autoimmun tilstand som har krevd eller krever behandling.
- Andre primær malignitet som krever aktiv terapi. Adjuvant hormonbehandling er tillatt.
- Bevis på aktiv sentralnervesystemleukemi ved registreringstidspunktet som bevist av cytologi eller patologi.
- Kjent ervervet immunsviktsyndrom (AIDS-relaterte sykdommer) eller humant immunsviktvirus (HIV) sykdom som krever antiretroviral behandling, eller har aktiv hepatitt B- eller C-infeksjon, eller alvorlig akutt respiratorisk syndrom coronavirus 2 (SARS-CoV-2)-infeksjon. Deltakere med en historie med SARS-CoV-2-infeksjon må ha fullført klinisk restitusjon minst 1 måned før registrering. - Tidligere behandling med et anti-CD123-rettet middel.
- Tidligere HSCT med tilbakefall utover 3 måneder kan bare inkluderes dersom immunsuppresjon er avslått i minimum 4 uker og ingen tegn på graft versus host sykdom (GVHD).
- Får på tidspunktet for første undersøkelseslegemiddel (IMP) administrering kortikosteroid som et samtidig medikament med kortikosteroiddose >10 mg/dag oral prednison eller tilsvarende,
- Tidligere behandling med cellulær terapi, f.eks. kimær antigenreseptor T-celle (CAR-T) eller kimær antigenreseptor NK-celle (CAR-NK).
- Samtidig behandling med andre undersøkelsesmedisiner.
- Strålebehandling, selv om det er lindrende i intensjon, kan ikke gis under studien.
- Profylaktisk bruk av hematopoietiske vekstfaktorer (f.eks. granulocytt-kolonistimulerende faktor (G-CSF), granulocytt-makrofag kolonistimulerende faktor (GM-CSF), erytropoietin) under DLT-observasjonsperioden kun i doseeskaleringsdelen. - Enkeltpersoner innkvartert i en institusjon på grunn av regulatorisk eller juridisk orden; fanger eller deltakere som er lovlig institusjonalisert.
- Gravide og ammende kvinner.
- Historie om solid organtransplantasjon, inkludert hornhinnetransplantasjon.
- Gjennomsnittlig QTc (ved bruk av Fridericia-korreksjonsberegningen) >470 millisekund (ms) ved screening.
Informasjonen ovenfor er ikke ment å inneholde alle hensyn som er relevante for en potensiell deltakelse i en klinisk studie.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: SAR443579
Doseeskalering: SAR443579 administrert intravenøst ved økende dosenivåer. Doseutvidelse: SAR443579 administrert intravenøst med anbefalt dose og tidsplan bestemt ut fra doseøkningen. |
Pulver til infusjonsvæske, oppløsning; ved IV-infusjon
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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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.
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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.
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Cycle 1 Day 1 up to Cycle 1 Day 28. Each cycle duration in induction period was 28 days.
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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.
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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.
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Cycle 1 Day 1 to Cycle 1 Day 28. Each cycle duration in induction period was 28 days.
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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.
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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.
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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.
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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.
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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.
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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.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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.
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The RDE of SAR443579 was determined based on the occurrence of DLTs in Cycle 1.
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Cycle 1 Day 1 up to Cycle 1 Day 28. Each cycle duration in induction period was 28 days.
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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).
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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.
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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).
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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
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Blood samples are collected just before treatment administration during repeated dosing to determine the Ctrough of SAR443579.
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At Days 1, 4, 8, 11, 15, 22, and 28 of Cycle 1
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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).
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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.
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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).
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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.
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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.
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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.
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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.
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Alternative CR rate was defined as percentage of participants with CR and CRh according to modified AML IWG 2003 response criteria.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
|
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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.
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Alternative CR rate was defined as percentage of participants with CR and CRh according to modified AML IWG 2003 response criteria.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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The OS was defined as time interval from the first day of treatment assignment to death from any cause.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Clinical Sciences & Operations, Sanofi
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
8. desember 2021
Primær fullføring (Faktiske)
13. juni 2025
Studiet fullført (Faktiske)
13. juni 2025
Datoer for studieregistrering
Først innsendt
19. oktober 2021
Først innsendt som oppfylte QC-kriteriene
19. oktober 2021
Først lagt ut (Faktiske)
20. oktober 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Hematologiske sykdommer
- Lymfesykdommer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Benmargssykdommer
- Leukemi, lymfoid
- Leukemi
- Hemic og lymfatiske sykdommer
- Forløpercelle lymfoblastisk leukemi-lymfom
- Myelodysplastiske syndromer
Andre studie-ID-numre
- TCD17197
- U1111-1266-7399 (Registeridentifikator: ICTRP)
- 2021-004287-98 (EudraCT-nummer)
- 2023-508357-58 (Registeridentifikator: CTIS)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Kvalifiserte forskere kan be om tilgang til data på pasientnivå og relaterte studiedokumenter, inkludert den kliniske studierapporten, studieprotokollen med eventuelle endringer, blankt case-rapportskjema, statistisk analyseplan og datasettspesifikasjoner.
Data på pasientnivå vil bli anonymisert og studiedokumenter vil bli redigert for å beskytte personvernet til forsøksdeltakerne.
Ytterligere detaljer om Sanofis kriterier for datadeling, kvalifiserte studier og prosess for å be om tilgang finner du på: https://vivli.org
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .