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NCT06423911ClinicalTrials.gov

Study of Olverembatinib (HQP1351) in Patients With CML-CP

A Global, Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML-CP)

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

Study comparing efficacy and safety of olverembatinib (investigational arm) vs. bosutinib (control arm) in patients with CML-CP (Part A). Study will also evaluate efficacy and safety of olverembatinib (single-arm) in CML-CP patients with T315I mutation (Part B). Patients who meet…

Fase 3333 partecipanti ricercati163 centri16 paesi

Categorie

Oncologia63%Ematologia38%

Registrato in 1 registro

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Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered after enrolment began (about 106 days after the recorded start)First posted 2024-05-21; recorded start 2024-02-05
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Open label (no blinding)Masking is recorded as none (open label)
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 41 other studies in this databaseCounted from the lead sponsor named in the record (Ascentage Pharma Group Inc.)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 3 conditions.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourMODERATE

A moderately rigorous design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding0/20

    Open-label

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre0/8

    Single site, or site count not stated

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration0/5

    Registered more than 30 days after the study start

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 333 participants (target), run at 163 sites, across 16 countries.

How this score is built
  • Enrolment24/40

    285 participants (target)

  • Site count0/25

    1 sites

  • Country count0/15

    Single country

  • Planned duration7/10

    Planned over about 24 months

  • Sponsor scale6/10

    Ascentage Pharma Group Inc. has led 42 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Sintesi

Study comparing efficacy and safety of olverembatinib (investigational arm) vs. bosutinib (control arm) in patients with CML-CP (Part A). Study will also evaluate efficacy and safety of olverembatinib (single-arm) in CML-CP patients with T315I mutation (Part B). Patients who meet ELN 2025 failure criteria while receiving bosutinib in Part A may be able to receive olverembatinib in crossover follow-on study.

Patologie

  • Chronic Myeloid Leukemia
  • CML
  • CML, Chronic Phase

Idoneità

SessoTutti
Età18 Years – Nessun massimo
Volontari saniNo

Idoneità come riportata nel registro

Inclusion Criteria Patients eligible for inclusion in this study must meet all of the following criteria: 1. Age ≥ 18 years old 2. Diagnosis of CML-CP 3. Part A: Previously treated with at least two approved TKIs; Part B: T315I mutation at screening and previously treated with at least one approved TKI, with no other effective and/or tolerable therapies available 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 5. Patient has adequate organ function Exclusion Criteria Patients eligible for this study must not meet any of the following criteria: 1. For Part A only: T315I or V299L mutation at any time prior to starting study treatment 2. Active infection that requires systemic drug therapy 3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs 4. Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients 5. Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients 6. Pregnant or nursing (lactating) women

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Tipo di studioInterventistico
FaseFase 3
AssegnazioneRandomizzata
Modello di interventoPARALLEL
Finalità principaleTREATMENT
MascheramentoNONE (0)
Arruolamento333 partecipanti ricercati

Sponsor e collaboratori

  • Ascentage Pharma Group Inc. Sponsor

Bracci e interventi

  • Part A, RCT, olverembatinib arm and bosutinib armOTHER

    Randomized controlled part that is designed to compare the efficacy and safety of olverembatinib (investigational arm) versus bosutinib (control arm) in patients with CML-CP, previously treated with at least two TKIs

  • Part B, SAT, olverembatinib armOTHER

    To evaluate the efficacy and safety of olverembatinib in the CML-CP patients with T315I mutation previously

Interventi

  • Farmaco Bosutinib

    Bosutnib QD

  • Farmaco olverembatinib

    olverembatinib QOD

Esiti misurati

  1. Esito primario

    24-Week MMR Rate (Part A)

    To compare the major molecular response (MMR) rate at 24 weeks for olverembatinib versus bosutinib

    Orizzonte temporale 24 weeks

  2. Esito primario

    24-Week MMR Rate (Part B)

    To evaluate the MMR rate by 24 weeks for olverembatinib in CML-CP patients with T315I mutation

    Orizzonte temporale 24 weeks

  3. Esito secondario

    Number of participants with treatment-emergent and treatment-related adverse events as assessed by CTCAE v5.0 (Parts A and B)

    According to CTCAE v5.0, the number and frequency of adverse events for test drug will be assessed.

    Orizzonte temporale 96 weeks after the last patient received the first study dose

  4. Esito secondario

    Characterization of population pharmacokinetics of olverembatinib (Parts A and B)

    Blood samples will be collected to measure the plasma concentration of olverembatinib

    Orizzonte temporale At the end of Cycle 1 and Cycle 2 (each cycle is 28 days)

  5. Esito secondario

    96-Week MMR Rate (Part A)

    To compare the major molecular response (MMR) rate at 96 weeks for olverembatinib versus bosutinib

    Orizzonte temporale 96 weeks

  6. Esito secondario

    96-Week MMR Rate (Part B)

    To evaluate the major molecular response (MMR) rate by 96 weeks for olverembatinib in CML-CP patients with T315I mutation

    Orizzonte temporale 96 weeks

  7. Esito secondario

    Cytogenic Response Rate (Part A)

    To compare the complete cytogenic response rate at all scheduled data collection time points for olverembatinib vs. bosutinib.

    Orizzonte temporale Through 96 weeks (i.e., at 24, 48, and 96 weeks)

  8. Esito secondario

    Cytogenic Response Rate (Part B)

    To evaluate the complete cytogenic response rate at all scheduled data collection time points for olverembatinib in CML-CP patients with T315I mutation

    Orizzonte temporale Through 96 weeks (i.e., at 24, 48, and 96 weeks)

  9. Esito secondario

    Progression Free Survival (PFS) (Part A)

    To compare duration of PFS (i.e., from the date of randomization to the earliest occurrence of documented disease progression to AP/BP or the date of death from any cause) for olverembatinib versus bosutinib

    Orizzonte temporale 5 years after the last patient received the first study dose

  10. Esito secondario

    Progression Free Survival (PFS) (Part B)

    To evaluate duration of PFS (i.e., from the date of enrollment to the earliest occurrence of documented disease progression to AP/BP or the date of death from any cause) for olverembatinib in CML-CP patients with T315I mutation

    Orizzonte temporale 5 years after the last patient received the first study dose

  11. Esito secondario

    Overall Survival (OS) (Part A)

    To compare OS (duration from date of randomization to date of death) for olverembatinib versus bosutinib

    Orizzonte temporale 5 years after the last patient received the first study dose

  12. Esito secondario

    Overall Survival (OS) (Part B)

    To evaluate OS (duration from date of randomization to date of death) for olverembatinib in CML-CP patients with T315I mutation

    Orizzonte temporale 5 years after the last patient received the first study dose

Date

Data di inizio5 febbraio 2024 (effettiva)
Conclusione primaria30 giugno 2027 (stimata)
Conclusione10 luglio 2028 (stimata)
Prima pubblicazione21 maggio 2024 (effettiva)
Ultimo aggiornamento15 settembre 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltasettembre 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

135 centri stanno reclutando

Australia

StrutturaCittàStato o regioneStato
Ascentage Investigative Site #2115AdelaideSouth AustraliaIn reclutamento
Ascentage Investigative Site #2107CampbelltownNew South WalesIn reclutamento
Ascentage Investigative Site #2105LiverpoolNew South WalesIn reclutamento
Ascentage Investigative Site #2106PerthWestern AustraliaIn reclutamento

Belgium

StrutturaCittàStato o regioneStato
Ascentage Investigative Site #5211AnderlechtIn reclutamento
Ascentage Investigative Site #5212GillyIn reclutamento
Ascentage Investigative Site #5208KortrijkIn reclutamento
Ascentage Investigative Site #5209RoeselareIn reclutamento
Ascentage Investigative Site #5210YvoirIn reclutamento

Canada

StrutturaCittàStato o regioneStato
Ascentage Investigative Site #8004TorontoIn reclutamento

France

StrutturaCittàStato o regioneStato
Ascentage Investigative Site #5037AmiensIn reclutamento
Ascentage Investigative Site #5015BobignyIn reclutamento
Ascentage Investigative Site #5017NiceIn reclutamento
Ascentage Investigative Site #5016RouenIn reclutamento
Ascentage Investigative Site #5023ToulouseIn reclutamento

Germany

StrutturaCittàStato o regioneStato
Ascentage Investigative Site #5708BerlinIn reclutamento
Ascentage Investigative Site #5709DresdenIn reclutamento

India

StrutturaCittàStato o regioneStato
Ascentage Investigative Site #9118BangaloreAttivo, non in reclutamento
Ascentage Investigative Site #9102HaryānaAttivo, non in reclutamento
Ascentage Investigative Site #9120HaryānaAttivo, non in reclutamento
Ascentage Investigative Site #9110HyderabadAttivo, non in reclutamento
Ascentage Investigative Site #9115KolkataAttivo, non in reclutamento
Ascentage Investigative Site #9116KolkataAttivo, non in reclutamento
Ascentage Investigative Site #9101New DelhiAttivo, non in reclutamento
Ascentage Investigative Site #9103New DelhiAttivo, non in reclutamento
Ascentage Investigative Site #9119PuneAttivo, non in reclutamento
Ascentage Investigative Site #9113ThiruvananthapuramAttivo, non in reclutamento

Italy

StrutturaCittàStato o regioneStato
Ascentage Investigative Site #5535BolognaIn reclutamento
Ascentage Investigative Site #5534CandioloIn reclutamento
Ascentage Investigative Site #5527CataniaIn reclutamento
Ascentage Investigative Site #5523LecceIn reclutamento
Ascentage Investigative Site #5529MeldolaIn reclutamento
Ascentage Investigative Site #5537MessinaNon ancora in reclutamento
Ascentage Investigative Site #5553MilanIn reclutamento
Ascentage Investigative Site #5530NaplesIn reclutamento
Ascentage Investigative Site #5524NovaraIn reclutamento
Ascentage Investigative Site #5525PadovaIn reclutamento
Ascentage Investigative Site #5526PisaIn reclutamento
Ascentage Investigative Site #5522RomaIn reclutamento
Ascentage Investigative Site #5528RomaIn reclutamento
Ascentage Investigative Site #5510RomaNon ancora in reclutamento
Ascentage Investigative Site #5521TorinoIn reclutamento
Ascentage Investigative Site #5552TorinoNon ancora in reclutamento
Ascentage Investigative Site #5536VareseIn reclutamento

Japan

StrutturaCittàStato o regioneStato
Ascentage Investigative Site #8101EhimeIn reclutamento
Ascentage Investigative Site #8102KyotoIn reclutamento
Ascentage Investigative Site #8112OkayamaIn reclutamento
Ascentage Investigative Site #8105OsakaIn reclutamento
Ascentage Investigative Site #8106SapporoIn reclutamento
Ascentage Investigative Site #8107SapporoIn reclutamento

Nella scheda del registro sono indicati altri 113 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

  1. 15 settembre 2026

    Data di conclusione posticipata

    Primary completion delayed 576 days

    2025-12-012027-06-30

  2. 15 settembre 2026

    Obiettivo di arruolamento modificato

    Enrollment target revised up from 285 to 333

    285333

  3. 15 settembre 2026

    Centro aggiunto

    162 sites added (163 total)

    1163

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06423911