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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)

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.
יצירת קשר עם המחקר

בקצרה

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…

שלב 3דרושים 333 משתתפים163 אתרים16 מדינות

קטגוריות

אונקולוגיה63%המטולוגיה38%

רשום במרשם אחד

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

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.

תקציר

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.

מצבים רפואיים

  • Chronic Myeloid Leukemia
  • CML
  • CML, Chronic Phase

זכאות

מיןהכול
גילאים18 Years – ללא מקסימום
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

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

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

סוג המחקרהתערבותי
שלבשלב 3
הקצאהאקראי
מודל ההתערבותPARALLEL
מטרה ראשיתTREATMENT
הסתרהNONE (0)
גיוסדרושים 333 משתתפים

נותן חסות ושותפים

  • Ascentage Pharma Group Inc. נותן חסות

זרועות והתערבויות

  • 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

התערבויות

  • תרופה Bosutinib

    Bosutnib QD

  • תרופה olverembatinib

    olverembatinib QOD

מדדי תוצאה

  1. מדד תוצאה ראשוני

    24-Week MMR Rate (Part A)

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

    מסגרת זמן 24 weeks

  2. מדד תוצאה ראשוני

    24-Week MMR Rate (Part B)

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

    מסגרת זמן 24 weeks

  3. מדד תוצאה משני

    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.

    מסגרת זמן 96 weeks after the last patient received the first study dose

  4. מדד תוצאה משני

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

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

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

  5. מדד תוצאה משני

    96-Week MMR Rate (Part A)

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

    מסגרת זמן 96 weeks

  6. מדד תוצאה משני

    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

    מסגרת זמן 96 weeks

  7. מדד תוצאה משני

    Cytogenic Response Rate (Part A)

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

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

  8. מדד תוצאה משני

    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

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

  9. מדד תוצאה משני

    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

    מסגרת זמן 5 years after the last patient received the first study dose

  10. מדד תוצאה משני

    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

    מסגרת זמן 5 years after the last patient received the first study dose

  11. מדד תוצאה משני

    Overall Survival (OS) (Part A)

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

    מסגרת זמן 5 years after the last patient received the first study dose

  12. מדד תוצאה משני

    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

    מסגרת זמן 5 years after the last patient received the first study dose

תאריכים

תאריך התחלה5 בפברואר 2024 (בפועל)
סיום ראשוני30 ביוני 2027 (משוער)
סיום10 ביולי 2028 (משוער)
פורסם לראשונה21 במאי 2024 (בפועל)
עודכן לאחרונה15 בספטמבר 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהספטמבר 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

135 אתרים מגייסים

Australia

מתקןעירמדינה או אזורמצב
Ascentage Investigative Site #2115AdelaideSouth Australiaמגייס
Ascentage Investigative Site #2107CampbelltownNew South Walesמגייס
Ascentage Investigative Site #2105LiverpoolNew South Walesמגייס
Ascentage Investigative Site #2106PerthWestern Australiaמגייס

Belgium

מתקןעירמדינה או אזורמצב
Ascentage Investigative Site #5211Anderlechtמגייס
Ascentage Investigative Site #5212Gillyמגייס
Ascentage Investigative Site #5208Kortrijkמגייס
Ascentage Investigative Site #5209Roeselareמגייס
Ascentage Investigative Site #5210Yvoirמגייס

Canada

מתקןעירמדינה או אזורמצב
Ascentage Investigative Site #8004Torontoמגייס

France

מתקןעירמדינה או אזורמצב
Ascentage Investigative Site #5037Amiensמגייס
Ascentage Investigative Site #5015Bobignyמגייס
Ascentage Investigative Site #5017Niceמגייס
Ascentage Investigative Site #5016Rouenמגייס
Ascentage Investigative Site #5023Toulouseמגייס

Germany

מתקןעירמדינה או אזורמצב
Ascentage Investigative Site #5708Berlinמגייס
Ascentage Investigative Site #5709Dresdenמגייס

India

מתקןעירמדינה או אזורמצב
Ascentage Investigative Site #9118Bangaloreפעיל, ללא גיוס
Ascentage Investigative Site #9102Haryānaפעיל, ללא גיוס
Ascentage Investigative Site #9120Haryānaפעיל, ללא גיוס
Ascentage Investigative Site #9110Hyderabadפעיל, ללא גיוס
Ascentage Investigative Site #9115Kolkataפעיל, ללא גיוס
Ascentage Investigative Site #9116Kolkataפעיל, ללא גיוס
Ascentage Investigative Site #9101New Delhiפעיל, ללא גיוס
Ascentage Investigative Site #9103New Delhiפעיל, ללא גיוס
Ascentage Investigative Site #9119Puneפעיל, ללא גיוס
Ascentage Investigative Site #9113Thiruvananthapuramפעיל, ללא גיוס

Italy

מתקןעירמדינה או אזורמצב
Ascentage Investigative Site #5535Bolognaמגייס
Ascentage Investigative Site #5534Candioloמגייס
Ascentage Investigative Site #5527Cataniaמגייס
Ascentage Investigative Site #5523Lecceמגייס
Ascentage Investigative Site #5529Meldolaמגייס
Ascentage Investigative Site #5537Messinaטרם מגייס
Ascentage Investigative Site #5553Milanמגייס
Ascentage Investigative Site #5530Naplesמגייס
Ascentage Investigative Site #5524Novaraמגייס
Ascentage Investigative Site #5525Padovaמגייס
Ascentage Investigative Site #5526Pisaמגייס
Ascentage Investigative Site #5522Romaמגייס
Ascentage Investigative Site #5528Romaמגייס
Ascentage Investigative Site #5510Romaטרם מגייס
Ascentage Investigative Site #5521Torinoמגייס
Ascentage Investigative Site #5552Torinoטרם מגייס
Ascentage Investigative Site #5536Vareseמגייס

Japan

מתקןעירמדינה או אזורמצב
Ascentage Investigative Site #8101Ehimeמגייס
Ascentage Investigative Site #8102Kyotoמגייס
Ascentage Investigative Site #8112Okayamaמגייס
Ascentage Investigative Site #8105Osakaמגייס
Ascentage Investigative Site #8106Sapporoמגייס
Ascentage Investigative Site #8107Sapporoמגייס

113 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

  1. 15 בספטמבר 2026

    תאריך הסיום נדחה

    Primary completion delayed 576 days

    2025-12-012027-06-30

  2. 15 בספטמבר 2026

    יעד הגיוס השתנה

    Enrollment target revised up from 285 to 333

    285333

  3. 15 בספטמבר 2026

    אתר נוסף

    162 sites added (163 total)

    1163

מרשם: ClinicalTrials.gov · NCT########

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