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치료되지 않은 BPDCN 및 재발성/불응성 BPDCN 환자에서 IMGN632에 대한 연구

2026년 8월 14일 업데이트: AbbVie

CD123 양성 급성 골수성 백혈병 및 기타 CD123 양성 혈액 악성종양 환자에게 정맥 주사로 투여된 IMGN632 단독요법의 1/2상, 다기관, 공개 라벨 연구

이것은 MTD를 결정하고 CD123+ 질환 환자에게 단일 요법으로 투여할 때 IMGN632의 안전성, 내약성, PK, 면역원성 및 항백혈병 활성을 평가하기 위한 공개 라벨, 다기관, 1/2상 연구입니다.

이 연구는 일선 BPDCN 환자의 중추 코호트와 재발성/불응성 BPDCN 환자 코호트를 등록하고 있습니다.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

이 연구는 용량 증량 단계를 완료했으며 현재 BPDCN 환자에서 안전성 프로파일을 추가로 특성화하고 IMGN632의 효능을 평가하기 위해 용량 확장 단계에 등록하고 있습니다. IMGN632는 각 주기의 제1일에 IV로 투여되며 주기는 21일마다 반복됩니다.

연구 유형

중재적

등록 (실제)

179

단계

  • 2 단계
  • 1단계

연락처 및 위치

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

연구 장소

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

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

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

설명

포함 기준:

  1. 질병 특성:

    ㅏ. 유동 세포 계측법 또는 IHC에 의한 CD123 양성 확인. 이전에 CD123 표적 제제를 받은 참가자는 폭발이 여전히 CD123 발현을 감지할 수 있는 한 허용됩니다.

  2. 확장 포함:

    • 코호트 1 - 이전에 1-3회 치료를 받은 재발성 또는 불응성 모세포형 형질세포 수지상 세포 신생물(BPDCN)이 있는 참가자
    • 코호트 6 - 선행 전신 요법을 받지 않은 스크리닝 시 최전선 신규 BPDCN을 갖는 참가자 및 PCHM을 갖고 이전 전신 요법을 받지 않은 최전선 BPDCN을 갖는 참가자.

참고: 코호트 6의 참가자는 국소 치료(방사선 요법, 외과적 절제, 광역동 요법)를 받았을 수 있습니다. 적격 참가자는 국소 요법 분야 또는 국소 요법 분야 이외의 질병에서 재발 또는 진행이 있어야 합니다.

제외 기준:

  1. 담당 의사의 판단에 따라 적절한 표준 치료 요법을 받는 참가자는 코호트 1~5에서 제외됩니다.
  2. 중추신경계(CNS) 질환이 있는 일선 BPDCN 참가자는 제외됩니다. 요추 천자는 약물 투여 전 28일의 스크리닝 기간 동안 수행되어야 합니다. CNS 질환의 병력이 있는 재발성 또는 불응성 BPDCN 참가자는 국소 치료를 받았고, CNS 질환의 증거가 없는 요추 천자가 최소 1회 있어야 하며 첫 번째 투여 전에 임상적으로 안정적이어야 합니다. CNS 예방을 위한 동시 요법 또는 제어된 CNS 질환에 대한 요법의 지속은 후원자의 승인으로 허용됩니다.
  3. 간 veno-occlusive 질병의 역사를 가진 참가자.
  4. 4등급 모세혈관 누출 증후군 또는 비심장 4등급 부종 병력이 있는 참여자는 예를 들어 타그락소푸스페르츠 또는 기타 병인과 관련하여 부적격합니다.
  5. 이전 암 치료와의 간격: 1. 이전에 국소 요법(예: 방사선 요법)을 받은 일선 BPDCN 참가자의 경우, 참가자는 이 연구에서 약물 투여 전 14일 이내에 치료를 받은 적이 없어야 합니다. 2. 재발 또는 불응성 BPDCN 참가자는 본 연구에서 약물 투여 전 14일 이내에 화학 요법, 면역 요법, 방사선 요법, 호르몬, 생물학적 제제 또는 임의의 조사 제제를 포함한 항암 요법을 받은 적이 없어야 합니다. 참가자는 이 이전 요법의 모든 급성 독성에서 기준선으로 회복해야 합니다.

참고: 체크포인트 억제제를 받은 참여자는 이 연구에서 약물 투여 전 28일 이내에 해당 요법을 받지 않아야 한다는 예외입니다.

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: 에스컬레이션 및 확장

확대: IMGN632는 재발성/불응성 AML, ALL 또는 BPDCN 참가자를 위해 2가지 다른 일정으로 IV에 의해 관리되었습니다.

확장: IMGN632는 IV에 의해 투여되었습니다:

  • 코호트 1: 이전 전신 요법을 1-3회 받은 재발성 또는 불응성 BPDCN 참가자(예: tagraxofusp-erzs 및/또는 BPDCN 치료에 적절하다고 판단되는 기타 전신 요법)
  • 코호트 2: 재발성 AML
  • 코호트 3: 재발성 또는 불응성 ALL
  • 코호트 4: 기타 재발성 또는 불응성 혈액 악성종양
  • 코호트 5: 대체 용량 또는 일정의 재발성 또는 불응성 AML
  • 코호트 6: 선행 전신 요법을 받지 않은 최전선 BPDCN 참가자 및 선행 또는 동시 혈액 악성 종양(PCHM)이 있고 이전 전신 요법을 받지 않은 최전선 BPDCN 참가자를 위한 중추 코호트.
의약품: IMGN632
CD123 표적 ADC

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Composite Complete Remission/Response (CCR) Rate As Assessed by Investigator in Frontline De Novo Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Participants
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Dose Escalation Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
기간: 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)
기간: 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
기간: Cycle 1 and Cycle 3 (each cycle length = 21 days)
Cycle 1 and Cycle 3 (each cycle length = 21 days)
Cmax of FGN849
기간: 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
기간: Cycle 1 and Cycle 3 (each cycle length = 21 days)
Cycle 1 and Cycle 3 (each cycle length = 21 days)
AUC0-last of FGN849
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AbbVie

수사관

  • 연구 책임자: ABBVIE INC., AbbVie

간행물 및 유용한 링크

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

일반 간행물

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)

2018년 1월 2일

기본 완료 (실제)

2024년 10월 2일

연구 완료 (추정된)

2026년 12월 30일

연구 등록 날짜

최초 제출

2017년 12월 21일

QC 기준을 충족하는 최초 제출

2017년 12월 28일

처음 게시됨 (실제)

2017년 12월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 14일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • IMGN632-0801
  • 2024-514195-40-00 (씨티스)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

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