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재발성 또는 불응성 급성 골수성 백혈병(R/R AML), B-세포 급성 림프구성 백혈병(B-ALL) 또는 고위험- 골수이형성증(HR-MDS)

2026년 6월 8일 업데이트: Sanofi

재발성 또는 불응성 급성 골수성 백혈병(R/R AML), B세포 급성 림프구성 백혈병(B-ALL ) 또는 고위험-골수이형성증(HR-MDS)

이것은 다양한 혈액 악성 종양에서 SAR443579의 안전성, 약동학, 약력학 및 항백혈병 활성을 평가하기 위한 오픈 라벨, 다기관, 1상/2상, 용량 증량 및 용량 확장 연구입니다.

연구 개요

상태

종료됨

정황

개입 / 치료

상세 설명

2.5년.

연구 유형

중재적

등록 (실제)

101

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

12년 이상 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

설명

포함 기준:

- 참여자는 시험 참여자 또는 법적 보호자가 정보에 입각한 동의서에 서명할 당시 12세 이상이어야 합니다.

Escalation Part 참가자 전용:

- 세계보건기구(WHO) 분류에 따라 1차 또는 2차 AML[급성 전골수성 백혈병(APL)을 제외한 모든 하위 유형] 진단이 확인되었습니다. AML 환자는 a), b) 또는 c) 기준 중 하나를 충족해야 하며 알려진 임상적 이점이 있는 이용 가능한 치료법이 없는(또는 부적격한) 환자로 제한됩니다.

a) 다음 i 또는 ii 중 하나에 불응성인 질병으로 정의되는 원발성 유도 실패(PIF) AML.

i) 기관별 집중 유도 시도. 유도 시도에는 고용량 및/또는 표준 용량 시타라빈 ± 안트라사이클린/안트라센디온 ± 항대사물질, 성장 인자 또는 표적 요법 포함 요법이 포함되거나 포함되지 않습니다.

예를 들면 다음과 같습니다.

  • 고용량 시타라빈(HiDAC) 함유 요법의 1주기
  • 리포솜 시타라빈 및 다우노루비신의 1주기

  • 2주기의 표준 용량 시타라빈 함유 요법 ii) 75세 이상 성인 또는 집중 유도 화학 요법을 사용할 수 없는 동반 질환이 있는 성인의 경우; PIF는 다음의 덜 집중적인 요법, 1 또는 2 중 하나에 불응성인 AML로 정의됩니다.

    1. 저메틸화제(HMA) 4주기 또는

    2. 2 주기 HMA + 베네토클락스 b) 조기 재발(ER) AML, CR 기간이 가장 최근 치료로부터 6개월 미만인 재발의 AML로 정의됨 c) 첫 번째 이상의 재발에서 백혈병

      • 123(CD123) + HR-MDS의 분화 군집 진단 확인, IPSS-R(Revised International Prognostic Scoring System) 위험 범주가 중간 이상이며 알려진 임상 치료가 없는(또는 부적격한) 환자로 제한됨 혜택.
  • 유도 요법에 적합하지 않고 다음 중 하나의 주기를 2회 이상 완료한 경우: 저메틸화제(예: 5 아자시티딘 또는 데시타빈) 및/또는 베네토클락스, 화학요법 또는 표적 제제.

  • 자가 줄기 세포 이식(ASCT) 대상이 아니며 유도 요법을 1회 이상 완료한 경우.

    • 알려진 임상적 이점이 있는 이용 가능한(또는 부적격한) 치료법이 없는 골수외 병변이 없는 CD123 + B-ALL의 확인된 진단.

확장 파트 참가자 전용:

  • 코호트 A 참가자의 경우: 이전 유도 치료에 대한 일차 불응성(PIF)이거나 이전 유도 치료에 대한 초기 완화 후 6개월 이내에 ER이 발생한 AML 환자에 대한 포함 기준을 충족하는 참가자.
  • 코호트 B 참가자의 경우: 이전 유도 치료에 대한 초기 완화 후 6개월 이상 경과한 후기 재발(LR)이 있는 AML 환자에 대한 포함 기준을 충족하는 참가자.
  • 체중 >40kg. -- 체중 >40kg. - - -

제외 기준:

  • Eastern Cooperative Oncology Group(ECOG) 수행 상태 >2(≥18세). Karnovsky Scale (16-17세)
  • 치료를 필요로 하거나 필요로 하는 활동성 또는 만성 자가면역 상태의 병력.
  • 적극적인 치료가 필요한 이차 원발성 악성 종양. 보조 호르몬 요법이 허용됩니다.
  • 세포학 또는 병리학에 의해 입증되는 등록 당시 활동성 중추신경계 백혈병의 증거.
  • 알려진 후천성 면역결핍 증후군(AIDS 관련 질병) 또는 항레트로바이러스 치료가 필요한 인간 면역결핍 바이러스(HIV) 질병, 활성 B형 또는 C형 간염 감염 또는 중증 급성 호흡기 증후군 코로나바이러스 2(SARS-CoV-2) 감염. SARS-CoV-2 감염 이력이 있는 참가자는 등록하기 최소 1개월 전에 임상 회복을 완료해야 합니다. - 항-CD123-지시 약제로 사전 치료.
  • 3개월을 초과하는 재발이 있는 이전 조혈모세포이식은 최소 4주 동안 면역 억제가 해제되고 이식편대숙주병(GVHD)의 증거가 없는 경우에만 포함될 수 있습니다.
  • 1차 시험용 의약품(IMP) 투여 시 코르티코스테로이드 용량 >10 mg/일의 경구 프레드니손 또는 이와 동등한 약물과 함께 병용 약물로서 코르티코스테로이드를 받고,
  • 세포 요법, 예를 들어 키메라 항원 수용체 T 세포(CAR-T) 또는 키메라 항원 수용체 NK 세포(CAR-NK)로 사전 치료.
  • 다른 연구 약물과의 동시 치료.
  • 방사선 요법은 의도적으로 완화적일지라도 연구 중에 제공되지 않을 수 있습니다.
  • DLT 관찰 기간 동안 조혈 성장 인자(예: 과립구 집락 자극 인자(G-CSF), 과립구 대식세포 집락 자극 인자(GM-CSF), 에리스로포이에틴)의 예방적 사용은 용량 증량 부분에서만. - 규제 또는 법적 질서로 인해 기관에 수용된 개인 법적으로 수용된 수감자 또는 참여자.
  • 임산부 및 모유 수유 여성.
  • 각막 이식을 포함한 고형 장기 이식의 병력.
  • 스크리닝 시 평균 QTc(Fridericia 보정 계산 사용) >470밀리초(msec).

위의 정보는 잠재적인 임상 시험 참여와 관련된 모든 고려 사항을 포함하기 위한 것이 아닙니다.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: SAR443579

용량 증량: SAR443579를 증량하는 용량 수준에서 정맥 내 투여.

용량 확장: SAR443579는 권장 용량과 용량 증량에서 결정된 일정으로 정맥 내 투여됩니다.
의약품: SAR443579
주입 용액 용 분말; IV 주입으로

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
기간: 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
기간: 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
기간: 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)
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Dose Expansion (Cohorts A1, A2, B and D): Recommended Dose for Expansion (RDE)
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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.

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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Sanofi

수사관

  • 연구 책임자: Clinical Sciences & Operations, Sanofi

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 12월 8일

기본 완료 (실제)

2025년 6월 13일

연구 완료 (실제)

2025년 6월 13일

연구 등록 날짜

최초 제출

2021년 10월 19일

QC 기준을 충족하는 최초 제출

2021년 10월 19일

처음 게시됨 (실제)

2021년 10월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 8일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • TCD17197
  • U1111-1266-7399 (레지스트리 식별자: ICTRP)
  • 2021-004287-98 (EudraCT 번호)
  • 2023-508357-58 (레지스트리 식별자: CTIS)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

자격을 갖춘 연구원은 임상 연구 보고서, 수정된 연구 프로토콜, 백지 사례 보고서 양식, 통계 분석 계획 및 데이터 세트 사양을 포함하여 환자 수준 데이터 및 관련 연구 문서에 대한 액세스를 요청할 수 있습니다. 시험 참가자의 개인 정보를 보호하기 위해 환자 수준 데이터는 익명으로 처리되고 연구 문서는 편집됩니다. Sanofi의 데이터 공유 기준, 적격 연구 및 액세스 요청 프로세스에 대한 자세한 내용은 https://vivli.org에서 확인할 수 있습니다.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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