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Primer estudio en humanos de la infusión de SAR443579 en participantes masculinos y femeninos de al menos 12 años de edad con leucemia mieloide aguda en recaída o refractaria (R/R AML), leucemia linfoblástica aguda de células B (B-ALL) o alto riesgo- mielodisplasia (HR-MDS)

8 de junio de 2026 actualizado por: Sanofi

Un estudio abierto, primero en humanos, de aumento de dosis de SAR443579 administrado como agente único por infusión intravenosa en pacientes con leucemia mieloide aguda en recaída o refractaria (R/R AML), leucemia linfoblástica aguda de células B (B-ALL) ) o mielodisplasia de alto riesgo (HR-MDS)

Este es un estudio abierto, multicéntrico, de Fase 1/Fase 2, de escalada de dosis y expansión de dosis para evaluar la seguridad, la farmacocinética, la farmacodinámica y la actividad antileucémica de SAR443579 en diversas neoplasias hematológicas.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

2,5 años

Tipo de estudio

Intervencionista

Inscripción (Actual)

101

Fase

  • Fase 2
  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Investigational Site Number :0360002
      • Melbourne, Victoria, Australia, 3004
        • Investigational Site Number :0360001
  • 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
  • Francia
      • Marseille, Francia, 13009
        • Investigational Site Number :2500002
      • Paris, Francia, 75010
        • Investigational Site Number :2500001
      • Paris, Francia, 75019
        • Investigational Site Number : 2500004
      • Villejuif, Francia, 94800
        • Investigational Site Number :2500003
  • Países Bajos
      • Amsterdam, Países Bajos, 1081 HV
        • Investigational Site Number :5280002
      • Groningen, Países Bajos, 9713 GZ
        • Investigational Site Number :5280003
      • Nijmegen, Países Bajos, 6525 GA
        • Investigational Site Number : 5280005
      • Rotterdam, Países Bajos, 3015 CE
        • Investigational Site Number :5280001
      • Utrecht, Países Bajos, 3584 CS
        • Investigational Site Number :5280004
  • Porcelana
      • Tianjin, Porcelana, 300020
        • Investigational Site Number : 1560001
      • Zhengzhou, Porcelana, 450008
        • Investigational Site Number : 1560003

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

12 años y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

- El participante debe tener ≥12 años en el momento en que el participante del ensayo o el tutor legal firmen el formulario de consentimiento informado.

Solo para participantes de la parte de escalamiento:

- Diagnóstico confirmado de AML primaria o secundaria [cualquier subtipo excepto leucemia promielocítica aguda (APL)] según la clasificación de la Organización Mundial de la Salud (OMS). Los pacientes con AML deben cumplir con uno de los siguientes criterios, a), b) o c) y se limitan a aquellos que no tienen terapia disponible (o no son elegibles) con beneficio clínico conocido.

a) AML con falla de inducción primaria (PIF, por sus siglas en inglés), definida como enfermedad refractaria a uno de los siguientes, i o ii.

i) Una tentativa de inducción intensiva, por institución. Los intentos de inducción incluyen dosis altas y/o dosis estándar de citarabina ± una antraciclina/antracenodiona ± un antimetabolito, con o sin factor de crecimiento o regímenes que contienen terapia dirigida.

Los ejemplos incluyen pero no se limitan a:

  • Un ciclo de régimen que contiene citarabina en dosis altas (HiDAC)
  • Un ciclo de citarabina liposomal y daunorrubicina

  • Dos ciclos de un régimen que contiene citarabina en dosis estándar ii) Para adultos de 75 años o más, o que tienen comorbilidades que impiden el uso de quimioterapia de inducción intensiva; La PIF se define como AML refractaria a uno de los siguientes regímenes menos intensivos, 1 o 2:

    1. 4 ciclos de agentes hipometilantes (HMA) o

    2. 2 ciclos de HMA + venetoclax b) LMA en recaída temprana (ER), definida como LMA en recaída con RC de duración < 6 meses desde el tratamiento más reciente c) Leucemia en la primera recaída o más alta

      • Diagnóstico confirmado de grupo de diferenciación 123 (CD123) + HR-MDS, con una categoría de riesgo de intermedio o superior del Sistema de puntuación de pronóstico internacional revisado (IPSS-R) y se limitan a aquellos sin terapia disponible (o no son elegibles) con clínica conocida. beneficio.
  • No elegible para la terapia de inducción y haber completado ≥2 ciclos de cualquiera de los siguientes: agente hipometilante (p. ej., 5 azacitidina o decitabina) y/o venetoclax, quimioterapia o agentes dirigidos.

  • No elegible para trasplante autólogo de células madre (ASCT) y haber completado ≥1 curso de terapia de inducción.

    • Diagnóstico confirmado de CD123 + B-ALL sin lesiones extramedulares que no tienen terapia disponible (o no son elegibles) con beneficio clínico conocido.

Solo para participantes en la parte de expansión:

  • Para participantes en la Cohorte A: Participantes que cumplen con los criterios de inclusión para pacientes con LMA que han sido refractarios primarios (PIF) al tratamiento de inducción anterior o que han tenido RE que se produce 6 meses o menos después de una remisión inicial en el tratamiento de inducción anterior.
  • Para participantes en la Cohorte B: Participantes que cumplen los criterios de inclusión para pacientes con AML que han tenido una recaída tardía (LR), que ocurre más de 6 meses después de una remisión inicial en el tratamiento de inducción anterior.
  • Peso corporal >40 kg. -- Peso corporal >40 kg. - - -

Criterio de exclusión:

  • Estado funcional del Eastern Cooperative Oncology Group (ECOG) >2 (≥18 años). Escala Karnovsky (16-17 años)
  • Historial de una condición autoinmune activa o crónica que ha requerido o requiere terapia.
  • Segunda neoplasia maligna primaria que requiere terapia activa. Se permite la terapia hormonal adyuvante.
  • Evidencia de leucemia activa del sistema nervioso central en el momento de la inscripción, como lo demuestra la citología o la patología.
  • Síndrome de inmunodeficiencia adquirida conocido (enfermedades relacionadas con el SIDA) o enfermedad del virus de la inmunodeficiencia humana (VIH) que requiere tratamiento antirretroviral, o que tiene una infección activa por hepatitis B o C, o una infección por coronavirus 2 (SARS-CoV-2) del síndrome respiratorio agudo severo. Los participantes con antecedentes de infección por SARS-CoV-2 deben haber completado la recuperación clínica al menos 1 mes antes de la inscripción. - Tratamiento previo con un agente dirigido anti-CD123.
  • Se puede incluir un HSCT previo con recaída de más de 3 meses solo si no se ha recibido inmunosupresión durante un mínimo de 4 semanas y no hay evidencia de enfermedad de injerto contra huésped (GVHD).
  • Recibir, en el momento de la primera administración del medicamento en investigación (IMP, por sus siglas en inglés), corticosteroides como medicación concomitante con una dosis de corticosteroides >10 mg/día de prednisona oral o el equivalente,
  • Tratamiento previo con terapia celular, por ejemplo, célula T con receptor de antígeno quimérico (CAR-T) o célula NK con receptor de antígeno quimérico (CAR-NK).
  • Tratamiento concurrente con otros fármacos en investigación.
  • La radioterapia, incluso si tiene un propósito paliativo, no se puede administrar durante el estudio.
  • Uso profiláctico de factores de crecimiento hematopoyéticos (p. ej., factor estimulante de colonias de granulocitos (G-CSF), factor estimulante de colonias de granulocitos y macrófagos (GM-CSF), eritropoyetina) durante el período de observación de DLT en la parte de escalada de dosis solamente. - Las personas alojadas en una institución por orden reglamentario o legal; presos o participantes legalmente institucionalizados.
  • Mujeres embarazadas y lactantes.
  • Antecedentes de trasplante de órgano sólido, incluido el trasplante de córnea.
  • QTc promedio (usando el cálculo de corrección de Fridericia) >470 milisegundos (mseg) en la selección.

La información anterior no pretende contener todas las consideraciones relevantes para una posible participación en un ensayo clínico.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: SAR443579

Aumento de dosis: SAR443579 administrado por vía intravenosa a niveles de dosis crecientes.

Expansión de dosis: SAR443579 administrado por vía intravenosa a la dosis recomendada y el programa determinado a partir del aumento de la dosis.
Droga: SAR443579
Polvo para solución para perfusión; por infusión IV

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Dose Expansion (Cohorts A1, A2, B and D): Recommended Dose for Expansion (RDE)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Sanofi

Investigadores

  • Director de estudio: Clinical Sciences & Operations, Sanofi

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

8 de diciembre de 2021

Finalización primaria (Actual)

13 de junio de 2025

Finalización del estudio (Actual)

13 de junio de 2025

Fechas de registro del estudio

Enviado por primera vez

19 de octubre de 2021

Primero enviado que cumplió con los criterios de control de calidad

19 de octubre de 2021

Publicado por primera vez (Actual)

20 de octubre de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

8 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Los investigadores calificados pueden solicitar acceso a datos a nivel de paciente y documentos de estudio relacionados, incluido el informe de estudio clínico, el protocolo de estudio con cualquier modificación, el formulario de informe de caso en blanco, el plan de análisis estadístico y las especificaciones del conjunto de datos. Los datos a nivel del paciente se anonimizarán y los documentos del estudio se redactarán para proteger la privacidad de los participantes del ensayo. Se pueden encontrar más detalles sobre los criterios de intercambio de datos de Sanofi, los estudios elegibles y el proceso para solicitar acceso en: https://vivli.org

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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