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Vaiheen 2 tutkimus CPI-0610:stä ruksolitinibin kanssa ja ilman sitä myelofibroosia sairastavilla potilailla

perjantai 8. toukokuuta 2026 päivittänyt: Constellation Pharmaceuticals

Vaiheen 1/2 tutkimus CPI-0610:stä, pienmolekyylisestä BET-proteiinien inhibiittorista: vaihe 1 (CPI-0610:n annoksen nostaminen potilailla, joilla on hematologisia pahanlaatuisia kasvaimia) ja 2. vaihe (CPI-0610:n annoksen laajentaminen ruxolitinibin kanssa ja ilman sitä) Myelofibroosin ja essentiaalisen trombosytopenian kanssa)

Vaihe 1 osa (täydellinen): Avoin, peräkkäinen pelabresibin annosten nostotutkimus potilailla, joilla on aiemmin hoidettu akuutti leukemia, myelodysplastinen oireyhtymä, myelodysplastinen/myeloproliferatiivinen kasvain ja myelofibroosi.

Vaihe 2 osa: Avoin tutkimus CPI-0610:stä ruksolitinibin kanssa ja ilman sitä myelofibroosia sairastavilla potilailla.

CPI-0610 on bromodomaiinin ja ekstraterminaalisten (BET) proteiinien pienimolekyylinen estäjä.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

336

Vaihe

  • Vaihe 2
  • Vaihe 1

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Alankomaat
    • Limburg
      • Maastricht, Limburg, Alankomaat, 6229 HX
        • Maastricht University Medical Center
    • North Holland
      • Amsterdam, North Holland, Alankomaat, 1081 HV
        • VUmcResearch B.V.
    • South Holland
      • Rotterdam, South Holland, Alankomaat, 3015 AA
        • Erasmus Universitair Medisch Centrum Rotterdam
  • Belgia
      • Antwerp, Belgia, 2060
        • ZNA Stuyvenberg Antwerpen
    • Viaams Braban
      • Leuven, Viaams Braban, Belgia, 3000
        • UZ Leuven - Campus Gasthuisberg
    • West-Vlaanderen
      • Bruges, West-Vlaanderen, Belgia, 8000
        • AZ Sint-Jan Burgge-Oostende AV- Campus Sint-Jan
  • Italia
      • Florence, Italia, 50134
        • Azienda Ospedaliero-Universitaria Careggi
      • Novara, Italia, 28100
        • AOU Maggiore della Carita
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italia, 40138
        • Institue of Hematology "L. and A. Seràgnoli"
      • Rimini, Emilia-Romagna, Italia, 47923
        • Servizio Sanitario Regionale Emilia-Romagna - Azienda Unita Sanitaria Locale (AUSL) di Rimini - Ospedale Infermi di Rimini
    • Liguria
      • Genoa, Liguria, Italia, 16132
        • AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can
    • Lombardy
      • Milan, Lombardy, Italia, 20122
        • Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda
      • Pavia, Lombardy, Italia, 27100
        • Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi
      • Varese, Lombardy, Italia, 21100
        • Ospedale di Circolo, PO Varese, AO Ospedale di Circolo e Fon
  • Kanada
    • Alberta
      • Edmonton, Alberta, Kanada, T6G 2G3
        • University of Alberta Hospital
    • British Columbia
      • Vancouver, British Columbia, Kanada, V6Z 2A5
        • St. Paul's Hospital
    • Ontario
      • Hamilton, Ontario, Kanada, L8V 5C2
        • Juravinski Cancer Centre
      • Toronto, Ontario, Kanada, M5G 2M9
        • Princess Margaret Cancer Centre
    • Quebec
      • Montreal, Quebec, Kanada, H3T 1E2
        • Jewish General Hospital
  • Puola
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Puola, 02-776
        • Instytut Hematologii I Transfuzjologii W Warszawie
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Puola, 80-952
        • Uniwersyteckie Centrum Kliniczne
  • Ranska
      • Paris, Ranska, 75010
        • CHU - Hopital Saint Louis - Centre D'Investigations Clinique
    • Gard
      • Nîmes, Gard, Ranska, 30029
        • Institut de cancérologie du Gard - Hematologie clinique
    • Haute-Garonne
      • Toulouse, Haute-Garonne, Ranska, 31059
        • CHRU de Lille - Hopital Claude Huriez
    • Hauts-de-France
      • Lille, Hauts-de-France, Ranska, 59037
        • CHRU de Lille - Hôpital Claude Huriez - Maladies du Sang
    • Île-de-France Region
      • Villejuif, Île-de-France Region, Ranska, 94805
        • Institut Gustave Roussy
  • Saksa
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Saksa, 53127
        • Universitatsklinikum Bonn
    • Saxony
      • Leipzig, Saxony, Saksa, 04103
        • Universitätsklinikum Leipzig AöR
  • Yhdistynyt kuningaskunta
      • Belfast, Yhdistynyt kuningaskunta, BT9 7AB
        • Belfast City Hospital
      • Cambridge, Yhdistynyt kuningaskunta, CB2 0QQ
        • University of Cambridge
      • Cardiff, Yhdistynyt kuningaskunta, CF14 4XW
        • University Hospital of Wales
      • Glasgow, Yhdistynyt kuningaskunta, G12 0YN
        • Beatson West of Scotland Cancer Centre
      • London, Yhdistynyt kuningaskunta, NW1 2PG
        • University College London Hospital's NHS foundation Trust
      • London, Yhdistynyt kuningaskunta, SE1 9RT
        • Guys and St Thomas' Hospital - Haematology
      • Manchester, Yhdistynyt kuningaskunta, M20 4BX
        • The Christie Hospital
    • Oxford
      • Headington, Oxford, Yhdistynyt kuningaskunta, OX3 7LE
        • Oxford University Hospitals
  • Yhdysvallat
    • Arizona
      • Phoenix, Arizona, Yhdysvallat, 85054
        • Mayo Clinic Arizona
    • California
      • Los Angeles, California, Yhdysvallat, 90095
        • UCLA Medical Center
    • Florida
      • Jacksonville, Florida, Yhdysvallat, 32224
        • Mayo Clinic Jacksonville
    • Illinois
      • Chicago, Illinois, Yhdysvallat, 60611
        • Northwestern University - Lurie Comprehensive Cancer Center
    • Massachusetts
      • Boston, Massachusetts, Yhdysvallat, 02114
        • Massachusetts General Hospital Cancer Center
    • Michigan
      • Ann Arbor, Michigan, Yhdysvallat, 48109
        • University of Michigan Medical Center
    • Missouri
      • St Louis, Missouri, Yhdysvallat, 63110
        • Washington University School of Medicne Neuromuscular Division Department of Neurology Research
    • New York
      • New York, New York, Yhdysvallat, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, Yhdysvallat, 10021
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, Yhdysvallat, 10065
        • Weill Medical College and New York Presbyterian Hospital
    • Texas
      • Houston, Texas, Yhdysvallat, 77030
        • The University of Texas MD Anderson Cancer Center
    • Wisconsin
      • Milwaukee, Wisconsin, Yhdysvallat, 53226
        • Froedtert & Medical College of Wisconsin

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

Sisällyttämiskriteerit:

Vaiheen 2 osa: Potilaat, joilla on vahvistettu MF-diagnoosi ja jotka täyttävät kaikki seuraavat kriteerit:

  • ANC ≥ 1 x 10^9/l ilman granulosyyttikasvutekijöiden apua
  • Perifeerisen veren blastiluku
  • ECOG-suorituskykytila ​​≤ 2.
  • Riittävät hematologiset, munuaisten, maksan ja hyytymisen laboratoriotutkimukset
  • Ei aikaisempaa hoitoa BET-estäjällä
  • Potilaiden on annettava kirjallinen tietoinen suostumus osallistua tähän tutkimukseen ennen minkään tutkimukseen liittyvän toimenpiteen suorittamista.

Käsivarsien 1 ja 2 osalta tulee ottaa huomioon seuraavat kriteerit:

  • Potilaat, joilla on vahvistettu MF-diagnoosi ja jotka täyttävät kaikki seuraavat kriteerit
  • Dynamic International Prognostic Scoring System (DIPSS) riskiluokka keskitaso-2 tai korkeampi
  • Pernan tilavuus ≥ 450 cm^3 MRI:llä tai CT:llä kohorttien 1B ja 2B TAI punasolujen siirrosta riippuen (määritelty keskimäärin ≥ 2 yksikköä punasolusiirtoja kuukaudessa (yhteensä yli 6 punasolusiirtoa) 12 viikon aikana ennen ilmoittautumista kohorteille 1A ja 2A)
  • Ainakin 2 oireita mitattavissa (pisteet ≥ 1) käyttämällä myelofibroosin oireiden arviointilomakkeen versiota 4.0 (MFSAF v4.0)
  • Verihiutaleiden määrä ≥ 75 x 10^9/l ilman trombopoieettisten tekijöiden apua tai verensiirtoja vähintään 14 päivän ajan
  • Käsivarsi (Arm 1): aiemmin hoidettu JAK-inhibiittorilla ja olet intolerantti, resistentti, tulenkestävä tai menettänyt vasteen JAK-estäjää kohtaan; eivät ole saaneet JAK-estäjää 2 viikon aikana ennen tutkimuslääkkeen aloittamista tai eivät ole kelvollisia hoidettaviksi JAK-estäjillä
  • Yhdistelmähaara (haara 2): Sinun on täytynyt saada ruksolitinibia yksinään ja oltava vakaalla annoksella vähintään 8 viikon ajan, mutta sinulla on sairaus, jota ruksolitinibi ei pysty hallitsemaan riittävästi

Käsivarren 3 (joille ei ole käytetty JAK-estäjiä) tulee ottaa huomioon seuraavat kriteerit:

  • Potilaat, joilla on vahvistettu MF-diagnoosi ja jotka täyttävät kaikki seuraavat kriteerit
  • Dynamic International Prognostic Scoring System (DIPSS) riskiluokka keskitaso-2 tai korkeampi
  • Verihiutaleiden määrä ≥ 100 x 10^9/l ilman trombopoieettisten tekijöiden tai verensiirtojen apua
  • Pernan tilavuus ≥ 450 cm^3 MRI/CT:llä
  • Vähintään 2 mitattavissa olevaa oireita (pistemäärä ≥ 3) tai kokonaispistemäärä ≥ 10 käyttämällä myelofibroosin oireiden arviointilomakkeen versiota 4.0 (MFSAF v4.0)
  • Aiempaa JAKi-hoitoa ei sallita

Käsivarren 4 (ET-laajennus) osalta tulee ottaa huomioon seuraavat kriteerit:

  • Potilaat, joilla on vahvistettu ET-diagnoosi
  • Korkean riskin sairaus, joka täyttää vähintään yhden seuraavista kriteereistä:
  • Ikä > 60 vuotta
  • Verihiutaleiden määrä > 1500 × 10^9/l (milloin tahansa potilaan taudin aikana)
  • Aiemmin dokumentoitu tromboosi, erytromelalgia tai migreeni
  • Edellinen ET:hen liittyvä verenvuoto
  • Diabetes tai verenpainetauti, joka vaatii lääkehoitoa > 6 kuukauden ajan

  • Sinulla on ≥ 2 oireita, joiden keskimääräinen pistemäärä on ≥ 3 7 päivän aikana ennen sykliä 1 päivää 1 tai keskimääräinen kokonaispistemäärä ≥ 15 7 päivän aikana ennen sykliä 1 päivää 1 käyttämällä MPN SAF:ää

    • Verihiutaleet > 600 × 10^9/l
    • Resistentti tai suvaitsematon HU:lle

Poissulkemiskriteerit:

  • Nykyinen tunnettu aktiivinen tai krooninen infektio ihmisen immuunikatoviruksen (HIV), hepatiitti B tai hepatiitti C kanssa.
  • Sydämen vajaatoiminta tai kliinisesti merkittävät sydänsairaudet
  • Potilaat, joilla on Child-Pugh-luokka B tai C
  • Maha-suolikanavan (GI) toiminnan heikkeneminen tai maha-suolikanavan sairaus, joka voi merkittävästi muuttaa pelabresibin ja/tai ruksolitinibin imeytymistä, mukaan lukien mikä tahansa korjaamaton pahoinvointi, oksentelu tai ripuli, joka on CTCAE-asteen > 1
  • Aiempi hoito BET-estäjällä.
  • Raskaana oleville tai imettäville naisille
  • Mikä tahansa muu samanaikainen vakava ja/tai hallitsematon samanaikainen sairaus, joka voi vaarantaa tutkimukseen osallistumisen
  • Potilaat, jotka eivät halua tai pysty noudattamaan tätä tutkimusprotokollaa.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Ei satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Phase 1
Patients were enrolled in sequential cohorts (acute leukemia, including acute myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), and acute undifferentiated or biphenotypic leukemia; chronic myelogenous leukemia (CML) in blast crisis; myelodysplastic syndrome (MDS); myelodysplastic/myeloproliferative neoplasms (MDS/MPN); or myelofibrosis (MF)) and received escalating doses of pelabresib (CPI-0610).
Lääke: Pelabresib
CPI-0610 was administered orally once daily for 14 consecutive days, followed by a 7-day break (1 cycle = 21 days)
Muut nimet:
  • CPI-0610
  • DAK539
Kokeellinen: Phase 2 (Arm 1): Prior JAKi Monotherapy Arm (MF patients treated with pelabresib alone)
  • Cohort 1A: Was open to patients with MF who were Transfusion Dependent (TD) and who had previously been treated with a JAKi and were intolerant, resistant, refractory, or had lost response to the JAKi, or were ineligible to be treated with a JAKi (pelabresib (CPI-0610) alone).
  • Cohort 1B: Was open to patients with MF who were not TD and who had previously been treated with a JAKi and were intolerant, resistant, refractory, or had lost response to the JAKi, or were ineligible to be treated with a JAKi (pelabresib (CPI-0610) alone).
Lääke: Pelabresib
CPI-0610 was administered orally once daily for 14 consecutive days, followed by a 7-day break (1 cycle = 21 days)
Muut nimet:
  • CPI-0610
  • DAK539
Kokeellinen: Phase 2 (Arm 2): Prior JAKi Combination Arm
  • Cohort 2A: Was open to patients with MF who were Transfusion Dependent (TD) and were taking ruxolitinib but had disease that was not adequately controlled by ruxolitinib (pelabresib (CPI-0610) + Ruxolitinib).
  • Cohort 2B: Was open to patients with MF who were not TD and were taking ruxolitinib but had disease that was not adequately controlled by ruxolitinib (pelabresib (CPI-0610) + Ruxolitinib).
Lääke: Pelabresib
CPI-0610 was administered orally once daily for 14 consecutive days, followed by a 7-day break (1 cycle = 21 days)
Muut nimet:
  • CPI-0610
  • DAK539
Lääke: Ruxolitinib
Ruxolitinib was given orally, twice daily (BID), on a continuous basis for 21 consecutive days of each 21-day cycle.
Kokeellinen: Phase 2 (Arm 3): JAKi Naïve Combination Arm
Was open to patients with MF who had not previously received a JAKi (pelabresib (CPI-0610) + Ruxolitinib).
Lääke: Pelabresib
CPI-0610 was administered orally once daily for 14 consecutive days, followed by a 7-day break (1 cycle = 21 days)
Muut nimet:
  • CPI-0610
  • DAK539
Lääke: Ruxolitinib
Ruxolitinib was given orally, twice daily (BID), on a continuous basis for 21 consecutive days of each 21-day cycle.
Kokeellinen: Phase 2 (Arm 4): Essential Thrombocythemia (ET) Monotherapy Arm
Was open to high-risk patients with ET who were resistant or intolerant to hydroxyurea (HU) (pelabresib (CPI-0610) alone).
Lääke: Pelabresib
CPI-0610 was administered orally once daily for 14 consecutive days, followed by a 7-day break (1 cycle = 21 days)
Muut nimet:
  • CPI-0610
  • DAK539

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Phase 1: Frequency of Dose-limiting Toxicities (DLTs)
Aikaikkuna: Up to 21 days
A dose-limiting toxicity (DLT) was defined as an adverse event or abnormal laboratory value assessed by the Investigator as unrelated to disease progression, intercurrent illness, or concomitant medications that occurred within the first cycle of treatment (21-day cycle) with pelabresib (CPI-0610), and that met any of the criteria specified in the protocol.
Up to 21 days
Phase 2 (Cohorts 1B, 2B, and Arm 3): Number of Participants With Splenic Response Rate (SVR35) at Week 24
Aikaikkuna: Week 24 (Cycle 9 Day 1)
Splenic Response Rate (SVR35) at Week 24 was defined as the proportion of participants who demonstrated a reduction of at least 35% in spleen size from baseline, as measured by imaging techniques (MRI or CT), following 24 weeks of treatment.
Week 24 (Cycle 9 Day 1)
Phase 2 (Cohorts 1A and 2A): Number of Participants Enrolled as Transfusion Dependent (TD) With Conversion Rate From Red Blood Cell (RBC) Transfusion Dependence (TD) to Transfusion Independence (TI)
Aikaikkuna: Any 12 consecutive weeks (rolling window) during active treatment with pelabresib (CPI-0610), from first dose through treatment discontinuation (up to approximately 8 years for Phase II)
Conversion rate was defined as the proportion of participants who converted from transfusion dependence (TD) to transfusion independence (TI). TD was characterized by receiving an average of at least 2 units of red blood cell (RBC) transfusions per month-amounting to a minimum of 6 units over the 12 weeks prior to enrollment-while TI was defined as the absence of RBC transfusions during any consecutive 12-week period.
Any 12 consecutive weeks (rolling window) during active treatment with pelabresib (CPI-0610), from first dose through treatment discontinuation (up to approximately 8 years for Phase II)
Phase 2 (Arm 4): Number of Participants With Complete Hematological Response (CHR) Rate
Aikaikkuna: Over 2 consecutive cycles (rolling window) (1 cycle = 21 days)
Complete Hematological Response (CHR) Rate was defined as the proportion of participants who fulfilled the criteria for CHR, based on the modified European LeukemiaNet (ELN) guidelines (Barosi et al 2009): platelet count ≤400 × 10⁹/L, white blood cell (WBC) count ≤10 × 10⁹/L, confirmation of laboratory values after one treatment cycle, and normal spleen size determined by palpation or imaging.
Over 2 consecutive cycles (rolling window) (1 cycle = 21 days)

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Phase 1: Number of Adverse Events and Serious Adverse Events as Assessed by CTCAE Criteria
Aikaikkuna: Up to approximately 6 months
The distribution of adverse events was performed through the analysis of frequencies for treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs), based on the monitoring of relevant clinical and laboratory safety parameters. Treatment-emergent adverse events (TEAEs) in this study were defined as events that began after the first dose of study treatment and continued until 30 days after the last dose, or events that were present prior to the first dose and increased in severity based on preferred term within 30 days following the last dose of pelabresib (CPI-0610).
Up to approximately 6 months
Phase 2 (All Arms): Number of Adverse Events and Serious Adverse Events as Assessed by CTCAE Criteria
Aikaikkuna: Up to approximately 387 weeks
The distribution of adverse events was performed through the analysis of frequencies for treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs), based on the monitoring of relevant clinical and laboratory safety parameters. Treatment-emergent adverse events (TEAEs) in this study were defined as events that began after the first dose of study treatment and continued until 30 days after the last dose, or events that were present prior to the first dose and increased in severity based on preferred term within 30 days following the last dose of pelabresib (CPI-0610).
Up to approximately 387 weeks
Phase 2 (All Arms): Symptom Improvement From the Patient Global Impression of Change (PGIC) at 12 and 24 Weeks
Aikaikkuna: Week 12 (Cycle 5 Day 1), Week 24 weeks (Cycle 9 Day 1)
The Patient Global Impression of Change (PGIC) was a single-question, patient-reported assessment that asked individuals to rate their overall change in myeloproliferative neoplasm (MPN) symptoms since starting study treatment. The participants selected one of seven options, ranging from 'Very much improved' to 'Very much worse'. 'No Change from Baseline' indicated stable symptoms (no improvement or worsening), negative change from Baseline indicated a reduction in symptom severity (improvement), and positive change from Baseline indicated an increase in symptom severity (worsening).
Week 12 (Cycle 5 Day 1), Week 24 weeks (Cycle 9 Day 1)
Phase 2 (Arms 1, 2 and 3): Percent Change From Baseline in Total Symptom Score (TSS) From the Myelofibrosis Symptom Assessment Form (MFSAF v4.0) at 12 and 24 Weeks
Aikaikkuna: Baseline, Week 12 (Cycle 5 Day 1), Week 24 (Cycle 9 Day 1)
The MFSAF (Myelofibrosis Symptom Assessment Form) was completed by participants every day for 7 days before Day 1 of each treatment cycle, including the 7 days before starting Cycle 1. It used a 24-hour recall format, asking participants to rate the worst severity of seven symptoms (fatigue, night sweats, pruritus, abdominal discomfort, pain under the ribs on the left side, early satiety, and bone pain) during the past 24 hours. Each symptom was rated on a scale from 0 (Absent) to 10 (Worst Imaginable). The Total Symptom Score (TSS) was the sum of 7 symptoms (range: 0-70). 'No Change from Baseline' indicated stable symptoms (no improvement or worsening), negative change from Baseline indicated a reduction in symptom severity (improvement), and positive change from Baseline indicated an increase in symptom severity (worsening).
Baseline, Week 12 (Cycle 5 Day 1), Week 24 (Cycle 9 Day 1)
Phase 2 (Arms 1, 2 and 3): Number of Participants Who Achieved a ≥ 50% Reduction in Total Symptom Score (TSS) at 12 and 24 Weeks
Aikaikkuna: Week 12 (Cycle 5 Day 1), Week 24 (Cycle 9 Day 1)
The proportion of study participants who experienced a reduction of at least 50% in their Total Symptom Score (TSS), as assessed using the Myelofibrosis Symptom Assessment Form (MFSAF v4.0), was evaluated at both 12 and 24 weeks relative to their baseline score.
Week 12 (Cycle 5 Day 1), Week 24 (Cycle 9 Day 1)
Phase 2 (Arms 1, 2 and 3): Number of Participants With Overall Splenic Response Rate (Overall SVR35)
Aikaikkuna: Through Phase II completion, an average of 6 years
Overall Splenic Response Rate (SVR35) was defined as the proportion of participants who achieved a reduction of at least 35% in spleen size from baseline, as measured by imaging (MRI or CT), at any point between Cycle 1 Day 1 and the End of Study Visit, whichever occurred first.
Through Phase II completion, an average of 6 years
Phase 2 (Arms 1, 2 and 3): Duration of Overall Splenic Response (Overall SVR35)
Aikaikkuna: From first onset of splenic response until loss of response, assessed up to approximately 6 years
Duration of Overall Splenic Response (overall SVR35) was defined as the time from the first occurrence of a at least 35% reduction in spleen volume from baseline until the earliest of the following: a reduction of less than 35% from baseline combined with an increase of more than 25% from the nadir in spleen volume (as measured by MRI or CT), or death. The nadir was defined as the lowest spleen volume recorded after baseline and up to the evaluation point at which the initial splenic response was achieved.
From first onset of splenic response until loss of response, assessed up to approximately 6 years
Phase 2 (Cohorts 1A and 2A): Number of Participants With Splenic Response Rate (SVR35) at 12 and 24 Weeks
Aikaikkuna: Week 12 (Cycle 5 Day 1), Week 24 weeks (Cycle 9 Day 1)
Splenic Response Rate (SVR35) at 12 and 24 weeks was defined as the proportion of participants who achieved a reduction of at least 35% in spleen size from baseline, as determined by imaging (MRI or CT), following 12 and 24 weeks of treatment, respectively.
Week 12 (Cycle 5 Day 1), Week 24 weeks (Cycle 9 Day 1)
Phase 2 (Cohorts 1A and 2A): Duration of Red Blood Cell (RBC) Transfusion Independence (TI) in Participants Who Enroll as Transfusion Dependent (TD)
Aikaikkuna: From first onset of TI to earliest onset of loss of TI, assessed up to approximately 6 years
Duration of Red Blood Cell (RBC) Transfusion Independence (TI) was defined as the longest continuous period during which participants, having achieved at least 12 weeks of transfusion independence, remained free from RBC transfusions.
From first onset of TI to earliest onset of loss of TI, assessed up to approximately 6 years
Phase 2 (Cohorts 1A and 2A): Early Anemic Response Rate in Participants Who Enroll as Transfusion Dependent (TD)
Aikaikkuna: Through Phase II completion, an average of 6 years
Early anemic response rate was defined as the proportion of participants who achieved an average increase of at least 1 g/dL in hemoglobin concentration over any rolling 8-week (56-day) period following baseline. This calculation was performed after applying the 14/3 day rule, which stipulates that hemoglobin measurements must be spaced at least 14 days apart, and that at least 3 such measurements are required within the 8-week window to ensure a reliable average. Importantly, this increase had to occur without any red blood cell (RBC) transfusions during the treatment period and up to the time of the latest hemoglobin assessment for each patient.
Through Phase II completion, an average of 6 years
Phase 2 (Cohorts 1B, 2B, and Arm 3): Number of Participants With Splenic Response Rate (SVR35) at 12 Weeks
Aikaikkuna: Week 12 (Cycle 5 Day 1)
Splenic Response Rate (SVR35) at Week 12 was defined as the proportion of participants who achieved a reduction of at least 35% in spleen size from baseline, as measured by imaging (MRI or CT), following 12 weeks of treatment.
Week 12 (Cycle 5 Day 1)
Phase 2 (Cohorts 1B, 2B, and Arm 3): Anemic Response Rate in Participants Who Enroll as Non-transfusion-dependent (Non-TD)
Aikaikkuna: Through Phase II completion, an average of 6 years
Anemic response was defined as a sustained average increase in hemoglobin concentration of at least 1.5 g/dL over any rolling 12-week (84-day) period following baseline. This calculation excluded periods involving red blood cell (RBC) transfusions and was performed after applying the 14/3-day rule for valid hemoglobin assessments. The response had to be maintained through to the most recent available hemoglobin measurement for each patient.
Through Phase II completion, an average of 6 years
Phase 2 (Arm 4): Percentage of Participants Who Achieve a ≥50% Reduction From Baseline in the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) Total Score
Aikaikkuna: Baseline, 12 weeks (Cycle 5, Day 1), 24 weeks (Cycle 9, Day 1)
The Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) is a patient-reported questionnaire designed to measure symptom burden in participants with myeloproliferative neoplasms (MPNs). Participants rate the severity of several symptoms (such as fatigue, night sweats, itching, abdominal discomfort, bone pain, early satiety, and others) over the past 24 hours. Each symptom is scored on a scale from 0 (absent/as good as it can be) to 10 (worst imaginable/as bad as it can be). The total score is the sum of all individual symptom scores, providing an overall measure of symptom burden. A 50% reduction in the MPN-SAF total score at 12 or 24 weeks means the patient's overall symptom burden has improved by half compared to their baseline (pre-treatment) score.
Baseline, 12 weeks (Cycle 5, Day 1), 24 weeks (Cycle 9, Day 1)
Phase 2 (Arm 4): Partial Hematological Response Rate (PHR)
Aikaikkuna: Over 2 consecutive cycles (rolling window) (1 cycle = 21 days)

Partial Hematological Response Rate (PHR) was defined as the proportion of participants who met the following criteria over two consecutive cycles up to the last administration of study treatment:

  • Platelet count > 400-600 x 10^9/L
  • WBC count within normal range (i.e., ≤ 10 x 10^9/L)
  • Laboratory results confirmed after 1 cycle (after 3weeks)
Over 2 consecutive cycles (rolling window) (1 cycle = 21 days)
Phase 2 (Arm 4): Overall Hematological Response Rate (OHR)
Aikaikkuna: Through Phase II completion, an average of 6 years
Confirmed Overall Hematological Response (OHR) Rate was defined as the proportion of participants with either a confirmed complete or a partial hematological response at any time.
Through Phase II completion, an average of 6 years
Phase 2 (Arm 4): Duration of Overall Hematological Response Rate (OHR)
Aikaikkuna: Through Phase II completion, an average of 6 years
Duration of Overall Hematological Response (OHR) Rate was defined as the time from when the overall hematological response was first met until the time at which the overall hematological response was lost, i.e., the criteria for an overall hematological response (CHR or PHR) were not observed or death occurred, whichever came first.
Through Phase II completion, an average of 6 years
Phase 2 (Arm 4): Rate of Hemorrhagic and Thromboembolic (TE) Events
Aikaikkuna: Through Phase II completion, an average of 6 years
Rate of hemorrhagic and thromboembolic (TE) events was defined as the proportion of participants with hemorrhagic or thromboembolic events throughout the study.
Through Phase II completion, an average of 6 years
Phase 2 (All Arms): Maximum Observed Plasma Concentration (Cmax) of Pelabresib
Aikaikkuna: Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.

Pharmacokinetic (PK) parameters were calculated based on Pelabresib plasma concentrations and actual sampling time points.

Cmax was listed and summarized using descriptive statistics.
Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.
Phase 2 (All Arms): Time to Reach Maximum Concentration (Tmax) of Pelabresib
Aikaikkuna: Cycle 1 Day 14 (predose, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.

Pharmacokinetic (PK) parameters were calculated based on Pelabresib plasma concentrations and actual sampling time points.

Tmax was listed and summarized using descriptive statistics.
Cycle 1 Day 14 (predose, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.
Phase 2 (All Arms): Predose (Trough) Concentration at the End of a Dosing Interval (Ctrough) of Pelabresib
Aikaikkuna: Cycle 1 Day 14 (predose, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.

Pharmacokinetic (PK) parameters were calculated based on Pelabresib plasma concentrations and actual sampling time points.

Ctrough was listed and summarized using descriptive statistics.
Cycle 1 Day 14 (predose, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.
Phase 2 (All Arms): Area Under the Concentration-Time Curve From Time Zero to the Last Observed Concentration (AUClast) of Pelabresib
Aikaikkuna: Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.

Pharmacokinetic (PK) parameters were calculated based on Pelabresib plasma concentrations and actual sampling time points.

AUClast was listed and summarized using descriptive statistics.
Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.
Phase 2 (All Arms): Area Under the Concentration-Time Curve From Time Zero to 8 Hours Post-dose at Steady State (AUC0-8,ss) of Pelabresib
Aikaikkuna: Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.

Pharmacokinetic (PK) parameters were calculated based on Pelabresib plasma concentrations and actual sampling time points.

AUC0-8,ss was listed and summarized using descriptive statistics.
Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.
Phase 2 (All Arms): Time of Last Measurable Concentration (Tlast) of Pelabresib
Aikaikkuna: Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.

Pharmacokinetic (PK) parameters were calculated based on Pelabresib plasma concentrations and actual sampling time points.

Tlast was listed and summarized using descriptive statistics.
Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.
Phase 2 (Arm 2 - Cohort 2A): Maximum Observed Plasma Concentration (Cmax) of Ruxolitinib
Aikaikkuna: Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.

Pharmacokinetic (PK) parameters were calculated based on ruxolitinib plasma concentrations and actual sampling time points.

Cmax was listed and summarized using descriptive statistics.
Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.
Phase 2 (Arm 2 - Cohort 2A): Time to Reach Maximum Concentration (Tmax) of Ruxolitinib
Aikaikkuna: Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.

Pharmacokinetic (PK) parameters were calculated based on ruxolitinib plasma concentrations and actual sampling time points.

Tmax was listed and summarized using descriptive statistics.
Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.
Phase 2 (Arm 2 - Cohort 2A): Predose (Trough) Concentration at the End of a Dosing Interval (Ctrough) of Ruxolitinib
Aikaikkuna: Cycle 1 Day 14 (predose, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.

Pharmacokinetic (PK) parameters were calculated based on ruxolitinib plasma concentrations and actual sampling time points.

Ctrough was listed and summarized using descriptive statistics.
Cycle 1 Day 14 (predose, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.
Phase 2 (Arm 2 - Cohort 2A): Area Under the Concentration-Time Curve From Time Zero to the Last Observed Concentration (AUClast) of Ruxolitinib
Aikaikkuna: Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.

Pharmacokinetic (PK) parameters were calculated based on ruxolitinib plasma concentrations and actual sampling time points.

AUClast was listed and summarized using descriptive statistics.
Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.
Phase 2 (Arm 2 - Cohort 2A): Area Under the Concentration-Time Curve From Time Zero to 8 Hours Post-dose at Steady State (AUC0-8,ss) of Ruxolitinib
Aikaikkuna: Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.

Pharmacokinetic (PK) parameters were calculated based on ruxolitinib plasma concentrations and actual sampling time points.

AUC0-8,ss was listed and summarized using descriptive statistics.
Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.
Phase 2 (Arm 2 - Cohort 2B): Maximum Observed Plasma Concentration (Cmax) of Ruxolitinib
Aikaikkuna: Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.

Pharmacokinetic (PK) parameters were calculated based on ruxolitinib plasma concentrations and actual sampling time points.

Cmax was listed and summarized using descriptive statistics.
Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.
Phase 2 (Arm 2 - Cohort 2B): Time to Reach Maximum Concentration (Tmax) of Ruxolitinib
Aikaikkuna: Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.

Pharmacokinetic (PK) parameters were calculated based on ruxolitinib plasma concentrations and actual sampling time points.

Tmax was listed and summarized using descriptive statistics.
Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.
Phase 2 (Arm 2 - Cohort 2B): Predose (Trough) Concentration at the End of a Dosing Interval (Ctrough) of Ruxolitinib
Aikaikkuna: Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.

Pharmacokinetic (PK) parameters were calculated based on ruxolitinib plasma concentrations and actual sampling time points.

Ctrough was listed and summarized using descriptive statistics.
Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.
Phase 2 (Arm 2 - Cohort 2B): Area Under the Concentration-Time Curve From Time Zero to the Last Observed Concentration (AUClast) of Ruxolitinib
Aikaikkuna: Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.

Pharmacokinetic (PK) parameters were calculated based on ruxolitinib plasma concentrations and actual sampling time points.

AUClast was listed and summarized using descriptive statistics.
Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.
Phase 2 (Arm 2 - Cohort 2B): Area Under the Concentration-Time Curve From Time Zero to 8 Hours Post-dose at Steady State (AUC0-8,ss) of Ruxolitinib
Aikaikkuna: Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.

Pharmacokinetic (PK) parameters were calculated based on ruxolitinib plasma concentrations and actual sampling time points.

AUC0-8,ss was listed and summarized using descriptive statistics.
Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.
Phase 2 (Arm 3): Maximum Observed Plasma Concentration (Cmax) of Ruxolitinib
Aikaikkuna: Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.

Pharmacokinetic (PK) parameters were calculated based on ruxolitinib plasma concentrations and actual sampling time points.

Cmax was listed and summarized using descriptive statistics.
Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.
Phase 2 (Arm 3): Time to Reach Maximum Concentration (Tmax) of Ruxolitinib
Aikaikkuna: Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.

Pharmacokinetic (PK) parameters were calculated based on ruxolitinib plasma concentrations and actual sampling time points.

Tmax was listed and summarized using descriptive statistics.
Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.
Phase 2 (Arm 3): Predose (Trough) Concentration at the End of a Dosing Interval (Ctrough) of Ruxolitinib
Aikaikkuna: Cycle 1 Day 14 (predose, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.

Pharmacokinetic (PK) parameters were calculated based on ruxolitinib plasma concentrations and actual sampling time points.

Ctrough was listed and summarized using descriptive statistics.
Cycle 1 Day 14 (predose, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.
Phase 2 (Arm 3): Area Under the Concentration-Time Curve From Time Zero to the Last Observed Concentration (AUClast) of Ruxolitinib
Aikaikkuna: Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.

Pharmacokinetic (PK) parameters were calculated based on ruxolitinib plasma concentrations and actual sampling time points.

AUClast was listed and summarized using descriptive statistics.
Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.
Phase 2 (Arm 3): Area Under the Concentration-Time Curve From Time Zero to 8 Hours Post-dose at Steady State (AUC0-8,ss) of Ruxolitinib
Aikaikkuna: Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.

Pharmacokinetic (PK) parameters were calculated based on ruxolitinib plasma concentrations and actual sampling time points.

AUC0-8,ss was listed and summarized using descriptive statistics.
Cycle 1 Day 14 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours post-dose). 1 cycle = 21 days.

Muut tulostoimenpiteet

Tulosmittaus
Aikaikkuna
Vaihe 2 (käsivarret 1, 2 ja 3): Arvioi vasteluokkasuhde
Aikaikkuna: Kansainvälisen työryhmän - Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) -kriteerien vastausaste 24 viikon jälkeen
Kansainvälisen työryhmän - Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) -kriteerien vastausaste 24 viikon jälkeen
Vaihe 2 (käsivarret 1, 2 ja 3): Arvioi punasolujen verensiirron nopeus ja punasolujen verensiirron riippuvuusaste
Aikaikkuna: Punasolujen keskimääräinen määrä tutkimuskuukaudessa, 24 viikkoon asti ja sen jälkeen
Punasolujen keskimääräinen määrä tutkimuskuukaudessa, 24 viikkoon asti ja sen jälkeen

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Constellation Pharmaceuticals

Yhteistyökumppanit

The Leukemia and Lymphoma Society

Tutkijat

  • Opintojohtaja: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Julkaisuja ja hyödyllisiä linkkejä

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Opiskelun aloitus (Todellinen)

Keskiviikko 16. heinäkuuta 2014

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Torstai 9. tammikuuta 2025

Opintojen valmistuminen (Todellinen)

Torstai 9. tammikuuta 2025

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Torstai 5. kesäkuuta 2014

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Torstai 5. kesäkuuta 2014

Ensimmäinen Lähetetty (Arvioitu)

Maanantai 9. kesäkuuta 2014

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Torstai 4. kesäkuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Perjantai 8. toukokuuta 2026

Viimeksi vahvistettu

Keskiviikko 1. huhtikuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 0610-02
  • 2018-000579-34 (EudraCT-numero)
  • CDAK539A12201 (Muu tunniste: Novartis)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

Novartis on sitoutunut jakamaan pätevien ulkoisten tutkijoiden kanssa, pääsy potilastason tietoihin ja tukemaan kliinisiä asiakirjoja tukikelpoisten tutkimusten perusteella. Riippumaton tarkastuspaneeli tarkistaa ja hyväksyy nämä pyynnöt tieteellisten ansioiden perusteella. Kaikki toimitetut tiedot on nimettömästi kunnioitettava tutkimukseen osallistuneiden potilaiden yksityisyyttä sovellettavien lakien ja asetusten mukaisesti.

Tämä kokeilutietojen saatavuus on www.clinicalStudyDatarequest.com -sivustossa kuvattujen kriteerien ja prosessin mukainen kriteeri ja prosessi

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

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Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

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Yhdysvalloissa valmistettu ja sieltä viety tuote

Ei

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