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再発または難治性の急性骨髄性白血病（R / R AML）、B細胞性急性リンパ芽球性白血病（B-ALL）または高リスクの12歳以上の男性および女性参加者におけるSAR443579注入の最初のヒト研究-骨髄異形成 (HR-MDS)

2026年6月8日 更新者：Sanofi

再発または難治性の急性骨髄性白血病（R / R AML）、B細胞急性リンパ芽球性白血病（B-ALL ）または高リスク骨髄異形成（HR-MDS）

これは、さまざまな血液悪性腫瘍における SAR443579 の安全性、薬物動態、薬力学、および抗白血病活性を評価するための、非盲検、多施設、フェーズ 1/フェーズ 2、用量漸増および用量拡大試験です。

調査の概要

状態

終了しました

条件

介入・治療

詳細な説明

2.5年。

研究の種類

介入

入学 (実際)

101

段階

  • フェーズ2
  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

12年歳以上 (子、大人、高齢者)

健康ボランティアの受け入れ

いいえ

説明

包含基準:

-参加者は、治験参加者または法定後見人がインフォームドコンセントフォームに署名した時点で12歳以上でなければなりません。

エスカレーション パートの参加者のみ:

-世界保健機関（WHO）の分類による、一次または二次AML [急性前骨髄球性白血病（APL）を除く任意のサブタイプ]の確定診断。 AML 患者は、次の基準 a)、b)、または c) のいずれかを満たす必要があり、既知の臨床的利益のある利用可能な (または不適格な) 治療法がない患者に限定されます。

a) 一次誘導不全 (PIF) AML、以下の i または ii のいずれかに難治性であると定義される。

i) 機関ごとの集中的な誘導の試み。 導入の試みには、高用量および/または標準用量のシタラビン±アントラサイクリン/アントラセンジオン±代謝拮抗薬が含まれ、成長因子または標的療法を含むレジメンの有無にかかわらず。

例には以下が含まれますが、これらに限定されません。

  • 高用量シタラビン (HiDAC) を含むレジメンの 1 サイクル
  • リポソーム シタラビンとダウノルビシンの 1 サイクル

  • シタラビンを含む標準用量のレジメンを 2 サイクル ii) 75 歳以上の成人、または強力な導入化学療法の使用を妨げる併存疾患がある成人。 PIF は、以下の強度の低いレジメン 1 または 2 のいずれかに不応の AML として定義されます。

    1. 低メチル化剤 (HMA) の 4 サイクルまたは

    2. 2 サイクルの HMA + ベネトクラクス b) 早期再発 (ER) AML、最近の治療からの CR 期間が 6 か月未満の再発の AML として定義 c) 最初の再発またはそれ以上の再発の白血病

      • -分化群123（CD123）+ HR-MDSの確定診断、改訂された国際予後スコアリングシステム（IPSS-R）のリスクカテゴリが中程度以上であり、利用可能な（または不適格な）治療法がないものに限定されている既知の臨床的利点。
  • -導入療法の対象ではなく、次のいずれかの2サイクル以上を完了した：低メチル化剤（例、5アザシチジンまたはデシタビン）および/またはベネトクラクス、化学療法、または標的薬剤。

  • -自家幹細胞移植（ASCT）の対象ではなく、1コース以上の導入療法を完了しました。

    • -CD123 + B-ALLの診断が確認されており、臨床的利益が知られている利用可能な（または不適格な）治療法がない髄外病変のない患者。

エキスパンションパート参加者限定：

  • コホートAの参加者の場合：以前の導入治療に対して一次難治性（PIF）であったAML患者の選択基準を満たす参加者、または以前の導入治療の最初の寛解後6か月以内にERが発生した。
  • コホートBの参加者の場合：遅発性再発（LR）があり、以前の導入治療での最初の寛解から6か月以上経過したAML患者の選択基準を満たす参加者。
  • 体重40kg以上。 -- 体重 >40 kg。 - - -

除外基準:

  • -東部共同腫瘍学グループ（ECOG）のパフォーマンスステータス> 2（18歳以上）。 カルノフスキー・スケール（16～17歳）
  • -治療を必要とする、または必要とする活動性または慢性の自己免疫状態の病歴。
  • 積極的な治療が必要な 2 番目の原発性悪性腫瘍。 補助ホルモン療法は許可されています。
  • -細胞学または病理学によって証明される、登録時の活動性中枢神経系白血病の証拠。
  • -既知の後天性免疫不全症候群（エイズ関連疾患）または抗レトロウイルス治療を必要とするヒト免疫不全ウイルス（HIV）疾患、または活動性B型またはC型肝炎感染症、または重症急性呼吸器症候群コロナウイルス2（SARS-CoV-2）感染症。 -SARS-CoV-2感染の病歴を持つ参加者は、登録の少なくとも1か月前に臨床的回復を完了している必要があります。 -抗CD123指向剤による以前の治療。
  • 3 か月を超える再発を伴う以前の HSCT は、最低 4 週間の免疫抑制がなく、移植片対宿主病 (GVHD) の証拠がない場合にのみ含めることができます。
  • 最初の治験薬（IMP）投与時にコルチコステロイドを併用薬として受け取り、経口プレドニゾンまたは同等のコルチコステロイド用量> 10 mg /日、
  • -細胞療法による前治療、例えば、キメラ抗原受容体T細胞（CAR-T）またはキメラ抗原受容体NK細胞（CAR-NK）。
  • -他の治験薬との同時治療。
  • 放射線療法は、緩和目的であっても、試験中に行わない場合があります。
  • -用量漸増パートのみのDLT観察期間中の造血成長因子（例、顆粒球コロニー刺激因子（G-CSF）、顆粒球マクロファージコロニー刺激因子（GM-CSF）、エリスロポエチン）の予防的使用。 - 規制または法的な秩序のために施設に収容されている個人;法的に制度化されている囚人または参加者。
  • 妊娠中および授乳中の女性。
  • -角膜移植を含む固形臓器移植の病歴。
  • -スクリーニング時の平均QTc（フリデリシア補正計算を使用）> 470ミリ秒（ミリ秒）。

上記の情報は、臨床試験への潜在的な参加に関連するすべての考慮事項を含むことを意図したものではありません。

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：SAR443579

用量漸増：漸増用量レベルで静脈内投与されたSAR443579。

用量拡大: SAR443579 は、用量漸増から決定された推奨用量およびスケジュールで静脈内投与されました。
薬：SAR443579
輸液用粉末; IV注入による

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Dose Expansion (Cohorts A1, A2, B and D): Recommended Dose for Expansion (RDE)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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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Sanofi

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  • スタディディレクター：Clinical Sciences & Operations、Sanofi

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年12月8日

一次修了 (実際)

2025年6月13日

研究の完了 (実際)

2025年6月13日

試験登録日

最初に提出

2021年10月19日

QC基準を満たした最初の提出物

2021年10月19日

最初の投稿 (実際)

2021年10月20日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月6日

QC基準を満たした最後の更新が送信されました

2026年6月8日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • TCD17197
  • U1111-1266-7399 (レジストリ識別子：ICTRP)
  • 2021-004287-98 (EudraCT番号)
  • 2023-508357-58 (レジストリ識別子：CTIS)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

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