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Primeiro estudo em humanos da infusão de SAR443579 em participantes do sexo masculino e feminino com pelo menos 12 anos de idade com leucemia mieloide aguda recidivante ou refratária (R/R AML), leucemia linfoblástica aguda de células B (B-ALL) ou alto risco mielodisplasia (HR-MDS)

8 de junho de 2026 atualizado por: Sanofi

Um estudo aberto, primeiro em humanos, de escalonamento de dose de SAR443579 administrado como agente único por infusão intravenosa em pacientes com leucemia mielóide aguda recidivante ou refratária (R/R AML), leucemia linfoblástica aguda de células B (B-ALL ) ou Mielodisplasia de alto risco (HR-MDS)

Este é um estudo aberto, multicêntrico, Fase 1/Fase 2, escalonamento de dose e estudo de expansão de dose para avaliar a segurança, farmacocinética, farmacodinâmica e atividade antileucêmica do SAR443579 em várias neoplasias hematológicas.

Visão geral do estudo

Status

Rescindido

Condições

Intervenção / Tratamento

Descrição detalhada

2,5 anos.

Tipo de estudo

Intervencional

Inscrição (Real)

101

Estágio

  • Fase 2
  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

12 anos e mais velhos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

- O participante deve ter ≥12 anos de idade no momento em que o participante do estudo ou responsável legal assinar o formulário de consentimento informado.

Somente para participantes da Parte de Escalação:

- Diagnóstico confirmado de LMA primária ou secundária [qualquer subtipo, exceto leucemia promielocítica aguda (APL)] de acordo com a classificação da Organização Mundial da Saúde (OMS). Os pacientes com LMA devem atender a um dos seguintes critérios, a), b) ou c) e estão limitados àqueles sem terapia disponível (ou inelegível) com benefício clínico conhecido.

a) Falha de Indução Primária (PIF) AML, definida como doença refratária a um dos seguintes, i ou ii.

i) Uma tentativa intensiva de integração, por instituição. As tentativas de indução incluem altas doses e/ou dose padrão de citarabina ± uma antraciclina/antracenediona ± um antimetabólito, com ou sem fator de crescimento ou regimes contendo terapia direcionada.

Os exemplos incluem, mas não estão limitados a:

  • Um ciclo de alta dose de citarabina (HiDAC) contendo regime
  • Um ciclo de citarabina lipossomal e daunorrubicina

  • Dois ciclos de regime de dose padrão contendo citarabina ii) Para adultos com 75 anos de idade ou mais, ou que tenham comorbidades que impeçam o uso de quimioterapia de indução intensiva; A PIF é definida como LMA refratária a um dos seguintes regimes menos intensivos, 1 ou 2:

    1. 4 ciclos de agentes hipometilantes (HMA) ou

    2. 2 ciclos HMA + venetoclax b) LMA de recaída precoce (ER), definida como LMA em recaída com duração de RC < 6 meses desde o tratamento mais recente c) Leucemia na primeira recaída ou mais recente

      • Diagnóstico confirmado de agrupamento de diferenciação 123 (CD123) + HR-MDS, com categoria de risco intermediária ou superior do Sistema Internacional de Pontuação de Prognóstico Revisado (IPSS-R) e limitado àqueles sem terapia disponível (ou inelegível) com sintomas clínicos conhecidos beneficiar.
  • Não elegível para terapia de indução e tendo completado ≥2 ciclos de qualquer um dos seguintes: agente hipometilante (por exemplo, 5 azacitidina ou decitabina) e/ou venetoclax, quimioterapia ou agentes direcionados.

  • Não elegível para transplante autólogo de células-tronco (ASCT) e tendo concluído ≥1 curso de terapia de indução.

    • Diagnóstico confirmado de CD123 + B-ALL sem lesões extramedulares que não têm terapia disponível (ou inelegível) com benefício clínico conhecido.

Apenas para participantes na parte de expansão:

  • Para participantes na Coorte A: Participantes que atendem aos critérios de inclusão para pacientes com LMA que foram refratários primários (PIF) ao tratamento de indução anterior ou que tiveram ER ocorrendo 6 meses ou menos após uma remissão inicial no tratamento de indução anterior.
  • Para os participantes da Coorte B: participantes que atendem aos critérios de inclusão para pacientes com LMA que tiveram recaída tardia (LR), ocorrendo mais de 6 meses após uma remissão inicial no tratamento de indução anterior.
  • Peso corporal >40 kg. -- Peso corporal >40 kg. - - -

Critério de exclusão:

  • Estado de desempenho do Eastern Cooperative Oncology Group (ECOG) >2 (≥18 anos). Escala de Karnovsky (16-17 anos)
  • História de uma condição autoimune ativa ou crônica que exigiu ou requer terapia.
  • Segunda malignidade primária que requer terapia ativa. A terapia hormonal adjuvante é permitida.
  • Evidência de leucemia ativa do sistema nervoso central no momento da inscrição, conforme evidenciado por citologia ou patologia.
  • Síndrome de imunodeficiência adquirida conhecida (doenças relacionadas à AIDS) ou doença do vírus da imunodeficiência humana (HIV) que requer tratamento antirretroviral, ou infecção ativa por hepatite B ou C, ou infecção por coronavírus 2 da síndrome respiratória aguda grave (SARS-CoV-2). Os participantes com histórico de infecção por SARS-CoV-2 devem ter concluído a recuperação clínica pelo menos 1 mês antes da inscrição. - Tratamento prévio com um agente direcionado ao anti-CD123.
  • O HSCT anterior com recidiva além de 3 meses pode ser incluído apenas se a imunossupressão estiver sem imunossupressão por um período mínimo de 4 semanas e sem evidência de doença do enxerto contra o hospedeiro (GVHD).
  • Receber no momento da primeira administração do medicamento experimental (PIM) corticosteróide como medicação concomitante com dose de corticosteróide > 10 mg/dia de prednisona oral ou equivalente,
  • Tratamento prévio com terapia celular, por exemplo, célula T receptora de antígeno quimérico (CAR-T) ou célula NK receptora de antígeno quimérico (CAR-NK).
  • Tratamento concomitante com outros medicamentos em investigação.
  • A radioterapia, mesmo que com intenção paliativa, não pode ser administrada durante o estudo.
  • Uso profilático de fatores de crescimento hematopoiéticos (por exemplo, fator estimulante de colônias de granulócitos (G-CSF), fator estimulante de colônias de macrófagos e granulócitos (GM-CSF), eritropoetina) durante o período de observação DLT apenas na parte de escalonamento de dose. - Indivíduos alojados em instituição por força de ordem regulamentar ou legal; presos ou participantes legalmente institucionalizados.
  • Mulheres grávidas e lactantes.
  • História de transplante de órgãos sólidos, incluindo transplante de córnea.
  • QTc médio (usando o cálculo de correção de Fridericia) >470 milissegundos (ms) na triagem.

As informações acima não pretendem conter todas as considerações relevantes para uma possível participação em um ensaio clínico.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: SAR443579

Escalonamento de dose: SAR443579 administrado por via intravenosa em níveis de dosagem crescentes.

Expansão da dose: SAR443579 administrado por via intravenosa na dose recomendada e esquema determinado a partir do escalonamento da dose.
Medicamento: SAR443579
Pó para solução para perfusão; por infusão IV

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Dose Expansion (Cohorts A1, A2, B and D): Recommended Dose for Expansion (RDE)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Sanofi

Investigadores

  • Diretor de estudo: Clinical Sciences & Operations, Sanofi

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

8 de dezembro de 2021

Conclusão Primária (Real)

13 de junho de 2025

Conclusão do estudo (Real)

13 de junho de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

19 de outubro de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de outubro de 2021

Primeira postagem (Real)

20 de outubro de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • TCD17197
  • U1111-1266-7399 (Identificador de registro: ICTRP)
  • 2021-004287-98 (Número EudraCT)
  • 2023-508357-58 (Identificador de registro: CTIS)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Pesquisadores qualificados podem solicitar acesso aos dados do paciente e documentos de estudo relacionados, incluindo o relatório do estudo clínico, protocolo do estudo com quaisquer alterações, formulário de relatório de caso em branco, plano de análise estatística e especificações do conjunto de dados. Os dados do paciente serão anonimizados e os documentos do estudo serão editados para proteger a privacidade dos participantes do estudo. Mais detalhes sobre os critérios de compartilhamento de dados da Sanofi, estudos elegíveis e processo de solicitação de acesso podem ser encontrados em: https://vivli.org

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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