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Studie av IMGN632 hos patienter med obehandlad BPDCN och återfall/refraktär BPDCN

14 augusti 2026 uppdaterad av: AbbVie

En fas 1/2, multicenter, öppen studie av IMGN632 monoterapi administrerad intravenöst hos patienter med CD123-positiv akut myeloid leukemi och andra CD123-positiva hematologiska maligniteter

Detta är en öppen, multicenter, fas 1/2-studie för att fastställa MTD och bedöma säkerhet, tolerabilitet, PK, immunogenicitet och anti-leukemiaktivitet av IMGN632 när det administreras som monoterapi till patienter med CD123+-sjukdom.

Studien registrerar en pivotal kohort av BPDCN-patienter i frontlinjen och en kohort av recidiverande/refraktära BPDCN-patienter.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Studien avslutade en dosupptrappningsfas och registrerar sig nu i en dosexpansionsfas för att ytterligare karakterisera säkerhetsprofilen och för att bedöma effekten av IMGN632 hos patienter med BPDCN. IMGN632 administreras av IV på dag 1 av varje cykel, med cykler som upprepas var 21:e dag.

Studietyp

Interventionell

Inskrivning (Faktisk)

179

Fas

  • Fas 2
  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Beskrivning

Inklusionskriterier:

  1. Sjukdomsegenskaper:

    a. Bekräftelse av CD123-positivitet genom flödescytometri eller IHC. Deltagare som mottagit tidigare CD123-inriktade medel kommer att tillåtas så länge som blaster fortfarande har detekterbart CD123-uttryck.

  2. Expansionsinkludering:

    • Kohort 1 - Deltagare med återfall eller refraktär blastisk plasmacytoid dendritisk cellneoplasma (BPCN) med 1-3 tidigare behandlingslinjer
    • Kohort 6 - Deltagare med frontline de novo BPDCN vid screening som inte har fått tidigare systemisk terapi och deltagare med frontline BPDCN som har PCHM och inte har fått tidigare systemisk terapi.

Obs: Deltagare i kohort 6 kan ha fått lokal terapi (strålbehandling, kirurgisk excision, fotodynamisk terapi). Berättigade deltagare måste ha ett återfall eller progression inom området lokal terapi ELLER sjukdom utanför området för lokal terapi.

Exklusions kriterier:

  1. Deltagare som, enligt sin behandlande läkares bedömning, har lämpliga standardbehandlingar kommer att uteslutas från kohorter 1 till 5.
  2. Frontline BPDCN-deltagare med sjukdom i centrala nervsystemet (CNS) kommer att exkluderas. En lumbalpunktion måste utföras under den 28-dagars screeningperioden, före läkemedelsadministrering. Återfallande eller refraktära BPDCN-deltagare med en känd historia av CNS-sjukdom måste ha behandlats lokalt, ha minst 1 lumbalpunktion utan tecken på CNS-sjukdom och måste vara kliniskt stabila före första dosen. Samtidig behandling för CNS-profylax eller fortsättning av terapi för kontrollerad CNS-sjukdom är tillåten med sponsorns godkännande.
  3. Deltagare med en historia av veno-ocklusiv leversjukdom.
  4. Deltagare med en historia av kapillärläckagesyndrom av grad 4 eller icke-kardiärt ödem av grad 4 är inte berättigade, t.ex. relaterade till tagraxofusp-erzs eller annan etiologi.
  5. Intervall från tidigare cancerbehandling: 1. För BPDCN-deltagare i frontlinjen med tidigare lokal terapi (t.ex. strålbehandling) får deltagarna inte ha fått behandling inom 14 dagar före läkemedelsadministrering i denna studie. 2. Återfallande eller refraktära BPDCN-deltagare får inte ha fått någon anti-cancerterapi inklusive kemoterapi, immunterapi, strålbehandling, hormonella, biologiska eller några undersökningsmedel inom 14 dagar före läkemedelsadministrering i denna studie. Deltagarna måste ha återhämtat sig till baslinjen från all akut toxicitet från denna tidigare behandling.

Observera: undantaget att deltagare som har fått en checkpoint-hämmare inte får ha fått den behandlingen inom 28 dagar före läkemedelsadministrering i denna studie.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Upptrappning och expansion

Upptrappning: IMGN632 administrerades av IV på 2 olika scheman för deltagare med återfall/refraktär AML, ALL eller BPDCN.

Expansion: IMGN632 administrerades av IV:

  • Kohort 1: Återfall eller refraktär BPDCN-deltagare som har fått 1-3 tidigare systemiska terapier (inkl. tagraxofusp-erzs och/eller annan systemisk behandling som anses lämplig för behandling av BPDCN)
  • Kohort 2: Återfall av AML
  • Kohort 3: Återfall eller refraktär ALLA
  • Kohort 4: Andra återfallande eller refraktära hematologiska maligniteter
  • Kohort 5: Återfallande eller refraktär AML vid alternativ dos eller schema
  • Kohort 6: Pivotal kohort för BPDCN-deltagare i frontlinjen som inte har fått tidigare systemisk terapi och deltagare med BPDCN i frontlinjen som har tidigare eller samtidig hematologisk malignitet (PCHM) och som inte har fått tidigare systemisk terapi.
Läkemedel: IMGN632
CD123-riktad ADC

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Composite Complete Remission/Response (CCR) Rate As Assessed by Investigator in Frontline De Novo Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Participants
Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AbbVie

Utredare

  • Studierektor: ABBVIE INC., AbbVie

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

2 januari 2018

Primärt slutförande (Faktisk)

2 oktober 2024

Avslutad studie (Beräknad)

30 december 2026

Studieregistreringsdatum

Först inskickad

21 december 2017

Först inskickad som uppfyllde QC-kriterierna

28 december 2017

Första postat (Faktisk)

29 december 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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