xMedica

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)

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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…

المرحلة 3مطلوب 333 مشاركاً163 موقعاً16 دولة

الفئات

علم الأورام63%أمراض الدم38%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

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.

ملخص

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.

الحالات

  • Chronic Myeloid Leukemia
  • CML
  • CML, Chronic Phase

الأهلية

الجنسالجميع
الأعمار18 Years – لا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةNONE (0)
التجنيدمطلوب 333 مشاركاً

الجهة الراعية والمتعاونون

  • Ascentage Pharma Group Inc. الجهة الراعية

الأذرع والتدخلات

  • 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

التدخلات

  • دواء Bosutinib

    Bosutnib QD

  • دواء olverembatinib

    olverembatinib QOD

مقاييس النتائج

  1. مقياس النتيجة الأولي

    24-Week MMR Rate (Part A)

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

    الإطار الزمني 24 weeks

  2. مقياس النتيجة الأولي

    24-Week MMR Rate (Part B)

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

    الإطار الزمني 24 weeks

  3. مقياس النتيجة الثانوي

    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.

    الإطار الزمني 96 weeks after the last patient received the first study dose

  4. مقياس النتيجة الثانوي

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

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

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

  5. مقياس النتيجة الثانوي

    96-Week MMR Rate (Part A)

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

    الإطار الزمني 96 weeks

  6. مقياس النتيجة الثانوي

    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

    الإطار الزمني 96 weeks

  7. مقياس النتيجة الثانوي

    Cytogenic Response Rate (Part A)

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

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

  8. مقياس النتيجة الثانوي

    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

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

  9. مقياس النتيجة الثانوي

    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

    الإطار الزمني 5 years after the last patient received the first study dose

  10. مقياس النتيجة الثانوي

    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

    الإطار الزمني 5 years after the last patient received the first study dose

  11. مقياس النتيجة الثانوي

    Overall Survival (OS) (Part A)

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

    الإطار الزمني 5 years after the last patient received the first study dose

  12. مقياس النتيجة الثانوي

    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

    الإطار الزمني 5 years after the last patient received the first study dose

التواريخ

تاريخ البدء5 فبراير 2024 (فعلي)
الإتمام الأولي30 يونيو 2027 (تقديري)
الإتمام10 يوليو 2028 (تقديري)
أول نشر21 مايو 2024 (فعلي)
آخر تحديث15 سبتمبر 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةسبتمبر 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

135 موقعاً قيد التجنيد

Australia

المنشأةالمدينةالولاية أو المنطقةالحالة
Ascentage Investigative Site #2115AdelaideSouth Australiaقيد التجنيد
Ascentage Investigative Site #2107CampbelltownNew South Walesقيد التجنيد
Ascentage Investigative Site #2105LiverpoolNew South Walesقيد التجنيد
Ascentage Investigative Site #2106PerthWestern Australiaقيد التجنيد

Belgium

المنشأةالمدينةالولاية أو المنطقةالحالة
Ascentage Investigative Site #5211Anderlechtقيد التجنيد
Ascentage Investigative Site #5212Gillyقيد التجنيد
Ascentage Investigative Site #5208Kortrijkقيد التجنيد
Ascentage Investigative Site #5209Roeselareقيد التجنيد
Ascentage Investigative Site #5210Yvoirقيد التجنيد

Canada

المنشأةالمدينةالولاية أو المنطقةالحالة
Ascentage Investigative Site #8004Torontoقيد التجنيد

France

المنشأةالمدينةالولاية أو المنطقةالحالة
Ascentage Investigative Site #5037Amiensقيد التجنيد
Ascentage Investigative Site #5015Bobignyقيد التجنيد
Ascentage Investigative Site #5017Niceقيد التجنيد
Ascentage Investigative Site #5016Rouenقيد التجنيد
Ascentage Investigative Site #5023Toulouseقيد التجنيد

Germany

المنشأةالمدينةالولاية أو المنطقةالحالة
Ascentage Investigative Site #5708Berlinقيد التجنيد
Ascentage Investigative Site #5709Dresdenقيد التجنيد

India

المنشأةالمدينةالولاية أو المنطقةالحالة
Ascentage Investigative Site #9118Bangaloreنشط، دون تجنيد
Ascentage Investigative Site #9102Haryānaنشط، دون تجنيد
Ascentage Investigative Site #9120Haryānaنشط، دون تجنيد
Ascentage Investigative Site #9110Hyderabadنشط، دون تجنيد
Ascentage Investigative Site #9115Kolkataنشط، دون تجنيد
Ascentage Investigative Site #9116Kolkataنشط، دون تجنيد
Ascentage Investigative Site #9101New Delhiنشط، دون تجنيد
Ascentage Investigative Site #9103New Delhiنشط، دون تجنيد
Ascentage Investigative Site #9119Puneنشط، دون تجنيد
Ascentage Investigative Site #9113Thiruvananthapuramنشط، دون تجنيد

Italy

المنشأةالمدينةالولاية أو المنطقةالحالة
Ascentage Investigative Site #5535Bolognaقيد التجنيد
Ascentage Investigative Site #5534Candioloقيد التجنيد
Ascentage Investigative Site #5527Cataniaقيد التجنيد
Ascentage Investigative Site #5523Lecceقيد التجنيد
Ascentage Investigative Site #5529Meldolaقيد التجنيد
Ascentage Investigative Site #5537Messinaلم يبدأ التجنيد بعد
Ascentage Investigative Site #5553Milanقيد التجنيد
Ascentage Investigative Site #5530Naplesقيد التجنيد
Ascentage Investigative Site #5524Novaraقيد التجنيد
Ascentage Investigative Site #5525Padovaقيد التجنيد
Ascentage Investigative Site #5526Pisaقيد التجنيد
Ascentage Investigative Site #5522Romaقيد التجنيد
Ascentage Investigative Site #5528Romaقيد التجنيد
Ascentage Investigative Site #5510Romaلم يبدأ التجنيد بعد
Ascentage Investigative Site #5521Torinoقيد التجنيد
Ascentage Investigative Site #5552Torinoلم يبدأ التجنيد بعد
Ascentage Investigative Site #5536Vareseقيد التجنيد

Japan

المنشأةالمدينةالولاية أو المنطقةالحالة
Ascentage Investigative Site #8101Ehimeقيد التجنيد
Ascentage Investigative Site #8102Kyotoقيد التجنيد
Ascentage Investigative Site #8112Okayamaقيد التجنيد
Ascentage Investigative Site #8105Osakaقيد التجنيد
Ascentage Investigative Site #8106Sapporoقيد التجنيد
Ascentage Investigative Site #8107Sapporoقيد التجنيد

يُدرَج 113 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

  1. 15 سبتمبر 2026

    تأخّر تاريخ الإتمام

    Primary completion delayed 576 days

    2025-12-012027-06-30

  2. 15 سبتمبر 2026

    تغيّر هدف التجنيد

    Enrollment target revised up from 285 to 333

    285333

  3. 15 سبتمبر 2026

    أُضيف موقع

    162 sites added (163 total)

    1163

السجل: ClinicalTrials.gov · NCT########

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