このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

未治療の BPDCN および再発/難治性 BPDCN 患者における IMGN632 の研究

2026年8月14日 更新者：AbbVie

CD123陽性急性骨髄性白血病およびその他のCD123陽性血液悪性腫瘍患者に静脈内投与されたIMGN632単剤療法の第1/2相多施設非盲検試験

これは、CD123+ 疾患の患者に単剤療法として投与した場合の IMGN632 の MTD を決定し、安全性、忍容性、PK、免疫原性、および抗白血病活性を評価するための非盲検多施設第 1/2 相試験です。

この研究では、最前線の BPDCN 患者の重要なコホートと、再発/難治性の BPDCN 患者のコホートを登録しています。

調査の概要

状態

積極的、募集していない

条件

介入・治療

詳細な説明

この研究は用量漸増段階を完了し、現在、安全性プロファイルをさらに特徴付け、BPDCN 患者における IMGN632 の有効性を評価するために、用量拡大段階に登録しています。 IMGN632 は、各サイクルの 1 日目に IV により投与され、サイクルは 21 日ごとに繰り返されます。

研究の種類

介入

入学 (実際)

179

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
    • Alabama
      • Birmingham、Alabama、アメリカ、35294
        • University of Alabama at Birmingham
    • Arizona
      • Gilbert、Arizona、アメリカ、85234
        • Banner Health MD Anderson Cancer Center
    • California
      • Duarte、California、アメリカ、91010
        • City of Hope Medical Center
      • Los Angeles、California、アメリカ、90095
        • UCLA
      • Stanford、California、アメリカ、94305
        • Stanford
    • Florida
      • Tampa、Florida、アメリカ、33612
        • Moffitt Cancer Center
    • Maryland
      • Baltimore、Maryland、アメリカ、21201
        • University of Maryland Medical Center
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02215
        • Dana-Farber Cancer Institute
    • New York
      • Buffalo、New York、アメリカ、14263
        • Roswell Park Cancer Institute
      • New York、New York、アメリカ、10065
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Charlotte、North Carolina、アメリカ、28204
        • Novant Health Cancer Institute Hematology
      • Durham、North Carolina、アメリカ、27710
        • Duke Cancer Institute
      • Winston-Salem、North Carolina、アメリカ、27103
        • Novant Health Cancer Institute Hematology - Forsyth
    • Texas
      • Dallas、Texas、アメリカ、75246
        • Baylor Scott & White University Medical Center
      • Houston、Texas、アメリカ、77030-7095
        • MD Anderson Cancer Center
    • Washington
      • Seattle、Washington、アメリカ、98109
        • Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance
  • イギリス
      • Oxford、イギリス、OX3 7LE
        • Churchill Hospital - Oxford
  • イタリア
      • Bologna、イタリア、40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola Malpighi
      • Meldola、イタリア、47014
        • Instituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
      • Milan、イタリア、20141
        • Instituto Europeo di Oncologia
      • Perugia、イタリア、06132
        • Azienda ospedaliera Santa Maria della Misericordia
  • スペイン
      • Valencia、スペイン、46026
        • Hospital Universitari i Politecnic La Fe
  • ドイツ
      • Cologne、ドイツ、50937
        • University Hospital of Cologne
      • Leipzig、ドイツ、04103
        • University Hospital of Leipzig
  • フランス
      • Amiens、フランス
        • Recherche Clinique-Hématologie
      • Besançon、フランス、25030
        • CHU de Besancon, Hopital Jean Minjoz
      • Marseille、フランス、13009
        • Institut Paoli Calmettes (Marseille)
      • Paris、フランス
        • Hôpital St Antoine
      • Pessac、フランス、33600
        • CHU Bordeaux Hôpital Haut-Lévêque

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

18年歳以上 (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:

  1. 疾患の特徴:

    a.フローサイトメトリーまたは IHC による CD123 陽性の確認。 以前に CD123 標的化剤を投与された参加者は、芽球がまだ検出可能な CD123 発現を持っている限り、許可されます。

  2. 拡張包含:

    • コホート 1 - 再発性または難治性の芽球性形質細胞様樹状細胞腫瘍 (BPDCN) の参加者で、1 ～ 3 回の治療歴がある患者
    • コホート 6 - 前に全身療法を受けていないフロントライン de novo BPDCN のスクリーニング時の参加者、および PCHM があり、以前に全身療法を受けていないフロントライン BPDCN の参加者。

注: コホート 6 の参加者は、局所療法 (放射線療法、外科的切除、光線力学療法) を受けた可能性があります。 適格な参加者は、局所療法の分野で再発または進行している必要があります または局所療法の分野外の疾患。

除外基準:

  1. 担当医師の判断で、適切な標準治療を受けている参加者は、コホート 1 ～ 5 から除外されます。
  2. 中枢神経系（CNS）疾患の最前線のBPDCN参加者は除外されます。 薬剤投与前の 28 日間のスクリーニング期間中に腰椎穿刺を行う必要があります。 CNS疾患の病歴が知られている再発または難治性のBPDCN参加者は、局所的に治療を受けている必要があり、CNS疾患の証拠のない腰椎穿刺が少なくとも1回あり、初回投与前に臨床的に安定している必要があります。 CNS 予防のための同時治療または管理された CNS 疾患のための治療の継続は、スポンサーの承認を得て許可されます。
  3. -肝臓の静脈閉塞性疾患の病歴を持つ参加者。
  4. グレード4の毛細血管漏出症候群、または心臓以外のグレード4の浮腫の病歴のある参加者は不適格です。
  5. 以前のがん治療からの間隔: 1. 前の局所療法（放射線療法など）を受けた最前線のBPDCN参加者の場合、参加者は、この研究の薬物投与前の14日以内に治療を受けてはなりません。 2. 再発または難治性の BPDCN 参加者は、化学療法、免疫療法、放射線療法、ホルモン療法、生物学的療法、または治験薬を含む抗がん療法を本研究の薬物投与前 14 日以内に受けてはなりません。 -参加者は、この以前の治療によるすべての急性毒性からベースラインまで回復している必要があります。

注：チェックポイント阻害剤を投与された参加者は、この研究の薬物投与前28日以内にその治療を受けてはならないという例外。

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：エスカレーションと拡大

エスカレーション: IMGN632 は、再発性/難治性の AML、ALL、または BPDCN の参加者に対して 2 つの異なるスケジュールで IV 投与されました。

拡張: IMGN632 は IV によって投与されました。

  • コホート1：以前に1～3回の全身療法（全身療法を含む）を受けた再発または難治性のBPDCN参加者。 tagraxofusp-erzs および/または BPDCN の治療に適切と考えられるその他の全身療法)
  • コホート 2: 再発した AML
  • コホート 3: 再発または難治性の ALL
  • コホート 4: その他の再発性または難治性の血液悪性腫瘍
  • コホート 5: 別の用量またはスケジュールで再発または難治性の AML を患う
  • コホート6：これまでに全身療法を受けていない最前線のBPDCN参加者、および以前または合併している血液悪性腫瘍（PCHM）があり、以前に全身療法を受けていない最前線のBPDCN参加者のための重要なコホート。
薬：IMGN632
CD123 ターゲット ADC

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
Composite Complete Remission/Response (CCR) Rate As Assessed by Investigator in Frontline De Novo Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Participants
時間枠：Up to approximately 81 months
CCR rate was defined as percentage of participants with complete remission/response (CR) and clinical complete remission (CRc). CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/microliter [μL]) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on computed tomography (CT); and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
Up to approximately 81 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Dose Escalation Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
時間枠：Up to approximately 81 months
An adverse event (AE) was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. This included an exacerbation of a pre-existing condition. SAEs included death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as any new AEs that begin or any pre-existing conditions that worsen in severity from the first dose of study drug through 30 days after the last dose or prior to the subsequent therapy, whichever occurs first.
Up to approximately 81 months
Dose Escalation Phase: Number of Participants With Dose-limiting Toxicities (DLTs)
時間枠：Up to approximately 81 months
DLT was defined as all treatment-emergent adverse events (TEAEs) or abnormal laboratory values that met the protocol-defined DLT criteria, including those TEAEs and abnormal laboratory values that resulted in a failure to meet the criteria for re-treatment. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Up to approximately 81 months
Maximum Plasma Concentration (Cmax) of IMGN632 (Antibody Drug Conjugate [ADC]) and Total Antibody
時間枠：Cycle 1 and Cycle 3 (each cycle length = 21 days)
Cycle 1 and Cycle 3 (each cycle length = 21 days)
Cmax of FGN849
時間枠：Cycle 1 and Cycle 3 (each cycle length = 21 days)
Cycle 1 and Cycle 3 (each cycle length = 21 days)
Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of IMGN632 (ADC) and Total Antibody
時間枠：Cycle 1 and Cycle 3 (each cycle length = 21 days)
Cycle 1 and Cycle 3 (each cycle length = 21 days)
AUC0-last of FGN849
時間枠：Cycle 1 and Cycle 3 (each cycle length = 21 days)
Cycle 1 and Cycle 3 (each cycle length = 21 days)
Number of Participants With Anti-drug Antibodies (ADAs) at Any Post-baseline Visit
時間枠：Up to approximately 81 months
Up to approximately 81 months
Dose Escalation Phase: Overall Response Rate (ORR), As Assessed by Investigator in Participants With AML
時間枠：Up to approximately 81 months
ORR was defined as percentage of participants with CR without minimal residual disease (CRMRD-), CR, CR with partial hematologic recovery (CRh), CR with incomplete recovery (CRi), morphologic leukemia-free state (MLFS), or partial response (PR). CRMRD-: CR with negativity for a genetic marker. CR: Morphologic CR <5% blasts; Absolute neutrophil count (ANC) >1000/μL; Platelets ≥100,000/μL; Participant independent of transfusions; No residual evidence of active extramedullary disease; MRD+ or unknown. CRh: Met requirements for CR except ANC >500/μL and platelets >50,000/μL. CRi: Met requirements for CR except either ANC <1000/μL or platelets <100,000/μL. MLFS: Bone marrow <5% blasts in an aspirate with spicules; No blasts with Auer rods or persistence of extramedullary disease; Marrow not "aplastic"; ≥200 cells should be enumerated or cellularity should be ≥10%. PR: Decrease of ≥50% in percentage of blasts to 5% to 25% in bone marrow aspirate (BMA) and normalization of blood counts.
Up to approximately 81 months
Dose Escalation Phase: CR+CRh Rate, As Assessed by Investigator in Participants With AML
時間枠：Up to approximately 81 months
CR+CRh rate was defined as percentage of participants with CR, and CRh. CR: Morphologic CR <5% blasts; Absolute neutrophil count (ANC) >1000/μL; Platelets ≥100,000/μL; Participant independent of transfusions; No residual evidence of active extramedullary disease; MRD+ or unknown. CRh: Met requirements for CR except ANC >500/μL and platelets >50,000/μL.
Up to approximately 81 months
Dose Escalation Phase: CR+CRh+CRi Rate, As Assessed by Investigator in Participants With AML
時間枠：Up to approximately 81 months
CR+CRh+CRi rate was defined as percentage of participants with CR, CRh, or CRi. CR: Morphologic CR <5% blasts; Absolute neutrophil count (ANC) >1000/μL; Platelets ≥100,000/μL; Participant independent of transfusions; No residual evidence of active extramedullary disease; MRD+ or unknown. CRh: Met requirements for CR except ANC >500/μL and platelets >50,000/μL. CRi: Met requirements for CR except either ANC <1000/μL or platelets <100,000/μL.
Up to approximately 81 months
CCR Rate As Assessed by Investigator in Participants With Relapsed/Refractory (R/R) BPDCN
時間枠：Up to approximately 81 months
CCR rate was defined as percentage of participants with CR and CRc. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
Up to approximately 81 months
Duration of CCR (DOCR) As Assessed by Investigator in Frontline De Novo BPDCN Participants With CR or CRc
時間枠：Up to approximately 81 months
DOCR was defined from the first response (CR or CRc) to the time of relapse or death from any cause, whichever came first. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. Median and 95% CI were calculated by Kaplan-Meier estimation.
Up to approximately 81 months
DOCR As Assessed by Investigator in R/R BPDCN Participants With CR or CRc
時間枠：Up to approximately 81 months
DOCR was defined from the first response (CR or CRc) to the time of relapse or death from any cause, whichever comes first. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
Up to approximately 81 months
DOCR As Assessed by Investigator in Total Frontline BPDCN Participants With CR or CRc
時間枠：Up to approximately 81 months
DOCR was defined from the first response (CR or CRc) to the time of relapse or death from any cause, whichever comes first. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
Up to approximately 81 months
Number of Participants With TEAEs in Participants Who Received IMGN632 As a Single Agent at the RP2D Level (0.045 mg/kg)
時間枠：Up to approximately 81 months
An AE was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. This included an exacerbation of a pre-existing condition. TEAEs were defined as any new AEs that began or any pre-existing conditions that worsen in severity from the first dose of study drug through 30 days after the last dose or prior to the subsequent therapy, whichever occurs first.. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Up to approximately 81 months
Rate of CR+CRc+CRh As Assessed by Investigator in Total R/R BPDCN Participants
時間枠：Up to approximately 81 months
Rate of CR+CRc+CRh: percentage of participants with CR, CRc, and CRh. CR: normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥1000/μL) and platelet count (≥100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) and platelet count (≥100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRh: normalization of neutrophil count (≥ 500/μL) and platelet count (≥ 50,000/μL); other criteria same as defined for CRc.
Up to approximately 81 months
Duration of CR+CRc+CRh As Assessed by Investigator in Total R/R BPDCN Participants
時間枠：Up to approximately 81 months
Duration of CR+CRc+CRh was defined as time from first response to time of relapse or death from any cause, whichever came first. CR: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) and platelet count (≥100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) and platelet count (≥100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRh: normalization of neutrophil count (≥ 500/μL) and platelet count (≥ 50,000/μL); other criteria same as defined for CRc.
Up to approximately 81 months
ORR As Assessed by Investigator in Total R/R BPDCN Participants
時間枠：Up to approximately 81 months
ORR: percentage of participants with CR, CRc, CRh, CRi, and PR. CR, CRc, and CRh as defined in Outcome Measure 20 above. CRi: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) or platelet count (≥100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. PR: Decreased by > 50% in blast percentage to 5%-25%; 50% to <100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; ≥50% decrease in the sum of the product of the diameters (SPD) of up to 6 largest dominant masses, no increase in size of other nodes; ≥ 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter), no increase in size of liver of spleen.
Up to approximately 81 months
Duration of Overall Response As Assessed by Investigator in Total R/R BPDCN Participants
時間枠：Up to approximately 81 months
Duration of overall response (CR, CRc, CRh, CRi, and PR) was defined as time from first response to time of relapse or death from any cause, whichever came first. CR, CRc, and CRh, CRi, and PR as defined in Outcome Measure 21 above.
Up to approximately 81 months
Overall Survival in Total R/R BPDCN Participants
時間枠：Up to approximately 81 months
Overall survival was defined as date of first dose until death from any cause.
Up to approximately 81 months
CCR Rate As Assessed by Investigator in All Frontline BPDCN Participants With Post-Treatment Consolidative Stem Cell Transplant (SCT)
時間枠：Up to approximately 81 months
CCR rate was defined as percentage of participants with CR and CRc. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
Up to approximately 81 months
CCR Rate As Assessed by Investigator in All R/R BPDCN Participants With Post-Treatment Consolidative SCT
時間枠：Up to approximately 81 months
CCR rate was defined as percentage of participants with CR and CRc. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
Up to approximately 81 months
Percentage of Participants With Post-baseline Transfusion Independence in BPDCN Participants
時間枠：Up to approximately 81 months
Post-baseline transfusion independence (red blood cell [RBC] and platelet transfusion independence) was defined as any 56-day period after Cycle 1 Day 1 in which the participant did not receive either a RBC or platelet transfusion.
Up to approximately 81 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

AbbVie

捜査官

  • スタディディレクター：ABBVIE INC.、AbbVie

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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)

2018年1月2日

一次修了 (実際)

2024年10月2日

研究の完了 (推定)

2026年12月30日

試験登録日

最初に提出

2017年12月21日

QC基準を満たした最初の提出物

2017年12月28日

最初の投稿 (実際)

2017年12月29日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月4日

QC基準を満たした最後の更新が送信されました

2026年8月14日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • IMGN632-0801
  • 2024-514195-40-00 (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?

いいえ

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

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する