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Estudo de IMGN632 em pacientes com BPDCN não tratado e BPDCN recidivante/refratário

14 de agosto de 2026 atualizado por: AbbVie

Um estudo fase 1/2, multicêntrico, aberto de monoterapia com IMGN632 administrada por via intravenosa em pacientes com leucemia mielóide aguda CD123 positiva e outras neoplasias hematológicas positivas para CD123

Este é um estudo aberto, multicêntrico, de Fase 1/2 para determinar a MTD e avaliar a segurança, tolerabilidade, farmacocinética, imunogenicidade e atividade antileucêmica do IMGN632 quando administrado como monoterapia a pacientes com doença CD123+.

O estudo está inscrevendo uma coorte principal de pacientes BPDCN da linha de frente e uma coorte de pacientes BPDCN recidivantes/refratários.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

O estudo concluiu uma fase de escalonamento de dose e agora está entrando em uma fase de expansão de dose para caracterizar ainda mais o perfil de segurança e avaliar a eficácia de IMGN632 em pacientes com BPDCN. IMGN632 é administrado por IV no Dia 1 de cada ciclo, com ciclos repetidos a cada 21 dias.

Tipo de estudo

Intervencional

Inscrição (Real)

179

Estágio

  • Fase 2
  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  1. Características da doença:

    a. Confirmação da positividade de CD123 por citometria de fluxo ou IHC. Os participantes que receberam agentes de direcionamento de CD123 anteriores serão permitidos, desde que os blastos ainda tenham expressão de CD123 detectável.

  2. Inclusão de expansão:

    • Coorte 1 - Participantes com neoplasia de células dendríticas plasmocitóide blástica recidivante ou refratária (BPDCN) com 1-3 linhas anteriores de terapia
    • Coorte 6 - Participantes com BPDCN de linha de frente na triagem que não receberam terapia sistêmica anterior e participantes com BPDCN de linha de frente que têm PCHM e não receberam terapia sistêmica anterior.

Nota: Os participantes da Coorte 6 podem ter recebido terapia local (radioterapia, excisão cirúrgica, terapia fotodinâmica). Os participantes elegíveis devem ter uma recorrência ou progressão no campo da terapia local OU doença fora do campo da terapia local.

Critério de exclusão:

  1. Os participantes que, no julgamento de seu médico assistente, tenham padrão apropriado de terapias de cuidado serão excluídos das Coortes 1 a 5.
  2. Os participantes da linha de frente do BPDCN com doença do sistema nervoso central (SNC) serão excluídos. Uma punção lombar deve ser realizada durante o período de triagem de 28 dias, antes da administração do medicamento. Os participantes do BPDCN recidivantes ou refratários com histórico conhecido de doença do SNC devem ter sido tratados localmente, ter pelo menos 1 punção lombar sem evidência de doença do SNC e devem estar clinicamente estáveis ​​antes da primeira dose. A terapia concomitante para profilaxia do SNC ou a continuação da terapia para doença controlada do SNC é permitida com a aprovação do Patrocinador.
  3. Participantes com história de doença veno-oclusiva do fígado.
  4. Participantes com histórico de síndrome de vazamento capilar de Grau 4 ou edema não cardíaco de Grau 4 não são elegíveis, por exemplo, relacionados a tagraxofusp-erzs ou outra etiologia.
  5. Intervalo da terapia oncológica anterior: 1. Para participantes BPDCN da linha de frente com terapia local anterior (por exemplo, radioterapia), os participantes não devem ter recebido tratamento nos 14 dias anteriores à administração do medicamento neste estudo. 2. Os participantes do BPDCN recidivantes ou refratários não devem ter recebido nenhuma terapia anticancerígena, incluindo quimioterapia, imunoterapia, radioterapia, agentes hormonais, biológicos ou quaisquer agentes em investigação dentro de 14 dias antes da administração do medicamento neste estudo. Os participantes devem ter recuperado a linha de base de toda a toxicidade aguda desta terapia anterior.

Nota: a exceção é que os participantes que receberam um inibidor de checkpoint não devem ter recebido essa terapia nos 28 dias anteriores à administração do medicamento neste estudo.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Escalação e Expansão

Escalonamento: IMGN632 foi administrado por IV em 2 horários diferentes para participantes com AML recidivante/refratária, ALL ou BPDCN.

Expansão: IMGN632 foi administrado por IV:

  • Coorte 1: Participantes do BPDCN recidivantes ou refratários que receberam 1-3 terapias sistêmicas anteriores (incl. tagraxofusp-erzs e/ou qualquer outra terapia sistêmica considerada apropriada para o tratamento de BPDCN)
  • Coorte 2: LMA recidivante
  • Coorte 3: ALL recidivante ou refratária
  • Coorte 4: Outras neoplasias hematológicas recidivantes ou refratárias
  • Coorte 5: LMA recidivante ou refratária em dose ou esquema alternativo
  • Coorte 6: Coorte principal para participantes BPDCN de linha de frente que não receberam terapia sistêmica anterior e participantes com BPDCN de linha de frente que têm malignidade hematológica prévia ou concomitante (PCHM) e não receberam terapia sistêmica anterior.
Medicamento: IMGN632
ADC direcionado a CD123

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Composite Complete Remission/Response (CCR) Rate As Assessed by Investigator in Frontline De Novo Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Participants
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Dose Escalation Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Prazo: 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)
Prazo: 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
Prazo: Cycle 1 and Cycle 3 (each cycle length = 21 days)
Cycle 1 and Cycle 3 (each cycle length = 21 days)
Cmax of FGN849
Prazo: 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
Prazo: Cycle 1 and Cycle 3 (each cycle length = 21 days)
Cycle 1 and Cycle 3 (each cycle length = 21 days)
AUC0-last of FGN849
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

AbbVie

Investigadores

  • Diretor de estudo: ABBVIE INC., AbbVie

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

2 de janeiro de 2018

Conclusão Primária (Real)

2 de outubro de 2024

Conclusão do estudo (Estimado)

30 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

21 de dezembro de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de dezembro de 2017

Primeira postagem (Real)

29 de dezembro de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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