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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)

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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…

Phase 3333 Teilnehmende gesucht163 Studienzentren16 Länder

Kategorien

Onkologie63%Hämatologie38%

In 1 Register registriert

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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.

Zusammenfassung

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.

Erkrankungen

  • Chronic Myeloid Leukemia
  • CML
  • CML, Chronic Phase

Eignung

GeschlechtAlle
Alter18 Years – Kein Höchstalter
Gesunde FreiwilligeNein

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

StudientypInterventionell
PhasePhase 3
ZuteilungRandomisiert
InterventionsmodellPARALLEL
Primäres ZielTREATMENT
VerblindungNONE (0)
Teilnahme333 Teilnehmende gesucht

Sponsor und Mitwirkende

  • Ascentage Pharma Group Inc. Sponsor

Studienarme und Interventionen

  • 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

Interventionen

  • Arzneimittel Bosutinib

    Bosutnib QD

  • Arzneimittel olverembatinib

    olverembatinib QOD

Endpunkte

  1. Primärer Endpunkt

    24-Week MMR Rate (Part A)

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

    Zeitrahmen 24 weeks

  2. Primärer Endpunkt

    24-Week MMR Rate (Part B)

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

    Zeitrahmen 24 weeks

  3. Sekundärer Endpunkt

    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.

    Zeitrahmen 96 weeks after the last patient received the first study dose

  4. Sekundärer Endpunkt

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

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

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

  5. Sekundärer Endpunkt

    96-Week MMR Rate (Part A)

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

    Zeitrahmen 96 weeks

  6. Sekundärer Endpunkt

    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

    Zeitrahmen 96 weeks

  7. Sekundärer Endpunkt

    Cytogenic Response Rate (Part A)

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

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

  8. Sekundärer Endpunkt

    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

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

  9. Sekundärer Endpunkt

    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

    Zeitrahmen 5 years after the last patient received the first study dose

  10. Sekundärer Endpunkt

    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

    Zeitrahmen 5 years after the last patient received the first study dose

  11. Sekundärer Endpunkt

    Overall Survival (OS) (Part A)

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

    Zeitrahmen 5 years after the last patient received the first study dose

  12. Sekundärer Endpunkt

    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

    Zeitrahmen 5 years after the last patient received the first study dose

Daten

Startdatum5. Februar 2024 (tatsächlich)
Primärer Abschluss30. Juni 2027 (geschätzt)
Abschluss10. Juli 2028 (geschätzt)
Erstveröffentlichung21. Mai 2024 (tatsächlich)
Zuletzt aktualisiert15. September 2026
Ergebnisse veröffentlichtIm Registereintrag nicht angegeben
Status zuletzt bestätigtSeptember 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

135 Studienzentren rekrutieren

Australia

EinrichtungStadtBundesland oder RegionStatus
Ascentage Investigative Site #2115AdelaideSouth AustraliaRekrutiert
Ascentage Investigative Site #2107CampbelltownNew South WalesRekrutiert
Ascentage Investigative Site #2105LiverpoolNew South WalesRekrutiert
Ascentage Investigative Site #2106PerthWestern AustraliaRekrutiert

Belgium

EinrichtungStadtBundesland oder RegionStatus
Ascentage Investigative Site #5211AnderlechtRekrutiert
Ascentage Investigative Site #5212GillyRekrutiert
Ascentage Investigative Site #5208KortrijkRekrutiert
Ascentage Investigative Site #5209RoeselareRekrutiert
Ascentage Investigative Site #5210YvoirRekrutiert

Canada

EinrichtungStadtBundesland oder RegionStatus
Ascentage Investigative Site #8004TorontoRekrutiert

France

EinrichtungStadtBundesland oder RegionStatus
Ascentage Investigative Site #5037AmiensRekrutiert
Ascentage Investigative Site #5015BobignyRekrutiert
Ascentage Investigative Site #5017NiceRekrutiert
Ascentage Investigative Site #5016RouenRekrutiert
Ascentage Investigative Site #5023ToulouseRekrutiert

Germany

EinrichtungStadtBundesland oder RegionStatus
Ascentage Investigative Site #5708BerlinRekrutiert
Ascentage Investigative Site #5709DresdenRekrutiert

India

EinrichtungStadtBundesland oder RegionStatus
Ascentage Investigative Site #9118BangaloreAktiv, rekrutiert nicht
Ascentage Investigative Site #9102HaryānaAktiv, rekrutiert nicht
Ascentage Investigative Site #9120HaryānaAktiv, rekrutiert nicht
Ascentage Investigative Site #9110HyderabadAktiv, rekrutiert nicht
Ascentage Investigative Site #9115KolkataAktiv, rekrutiert nicht
Ascentage Investigative Site #9116KolkataAktiv, rekrutiert nicht
Ascentage Investigative Site #9101New DelhiAktiv, rekrutiert nicht
Ascentage Investigative Site #9103New DelhiAktiv, rekrutiert nicht
Ascentage Investigative Site #9119PuneAktiv, rekrutiert nicht
Ascentage Investigative Site #9113ThiruvananthapuramAktiv, rekrutiert nicht

Italy

EinrichtungStadtBundesland oder RegionStatus
Ascentage Investigative Site #5535BolognaRekrutiert
Ascentage Investigative Site #5534CandioloRekrutiert
Ascentage Investigative Site #5527CataniaRekrutiert
Ascentage Investigative Site #5523LecceRekrutiert
Ascentage Investigative Site #5529MeldolaRekrutiert
Ascentage Investigative Site #5537MessinaRekrutierung noch nicht begonnen
Ascentage Investigative Site #5553MilanRekrutiert
Ascentage Investigative Site #5530NaplesRekrutiert
Ascentage Investigative Site #5524NovaraRekrutiert
Ascentage Investigative Site #5525PadovaRekrutiert
Ascentage Investigative Site #5526PisaRekrutiert
Ascentage Investigative Site #5522RomaRekrutiert
Ascentage Investigative Site #5528RomaRekrutiert
Ascentage Investigative Site #5510RomaRekrutierung noch nicht begonnen
Ascentage Investigative Site #5521TorinoRekrutiert
Ascentage Investigative Site #5552TorinoRekrutierung noch nicht begonnen
Ascentage Investigative Site #5536VareseRekrutiert

Japan

EinrichtungStadtBundesland oder RegionStatus
Ascentage Investigative Site #8101EhimeRekrutiert
Ascentage Investigative Site #8102KyotoRekrutiert
Ascentage Investigative Site #8112OkayamaRekrutiert
Ascentage Investigative Site #8105OsakaRekrutiert
Ascentage Investigative Site #8106SapporoRekrutiert
Ascentage Investigative Site #8107SapporoRekrutiert

113 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

  1. 15. September 2026

    Abschlussdatum nach hinten verschoben

    Primary completion delayed 576 days

    2025-12-012027-06-30

  2. 15. September 2026

    Teilnahmeziel geändert

    Enrollment target revised up from 285 to 333

    285333

  3. 15. September 2026

    Studienzentrum hinzugefügt

    162 sites added (163 total)

    1163

Register: ClinicalTrials.gov · NCT########

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