- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05594758
Named Patient Program for Olverembatinib (HQP1351)
February 6, 2024 updated by: Ascentage Pharma Group Inc.
Named Patient Program for Providing Access to Olverembatinib (HQP1351) to Countries Where the Drug is Not Available
This program will allow eligible patients access to Ascentage Pharma's novel drug candidate Olverembatinib (approved in China) on a named patient basis in over 100 countries ( with the exception of the USA and China) and regions where the drug is not available.
Study Overview
Status
Available
Intervention / Treatment
Detailed Description
Olverembatinib is a novel third generation BCR-ABL inhibitor that can effectively target a spectrum of BCR-ABL mutants, including the T315I mutation.
Olverembatinib is approved in China for the treatment of adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase chronic myeloid leukemia (CP-CML) or accelerated-phase CML (AP-CML) harboring the T315I mutation as confirmed by a validated diagnostic test1.
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 97 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Description
Inclusion Criteria:
• Patients who are suitable to receive Olverembatinib and for whom there is reasonable expectation that Olverembatinib may provide clinical benefit based on the medical judgment of their prescribing physician.
Exclusion Criteria:
- Existing risks of serious Arterial occlusive events (AOE), including myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and recent revascularization procedures
- Existing risks of serious Venous thromboembolic events (VTEs), including deep venous thrombosis, pulmonary embolism, and retinal vein thrombosis
- Existing serious heart conditions, including acute/chronic heart failure, coronary artery disease
- Existing conditions of severe liver malfunction
- Existing conditions of severe myelosuppression
- Existing conditions of severe hemorrhage
- Pregnant or baby feeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
October 21, 2022
First Submitted That Met QC Criteria
October 21, 2022
First Posted (Actual)
October 26, 2022
Study Record Updates
Last Update Posted (Actual)
February 7, 2024
Last Update Submitted That Met QC Criteria
February 6, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NPP Olverembatinib
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Olverembatinib
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The First Affiliated Hospital of Soochow UniversityRecruiting
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xunaNanfang Hospital of Southern Medical University; Sun Yat-Sen Memorial Hospital... and other collaboratorsWithdrawnProphylactic HQP1351 Therapy | Third Generation TKIChina
-
Shenzhen Second People's HospitalRecruitingChronic Myeloid Leukemia, Chronic Phase | Olverembatinib | Tyrosine Kinase InhibitorsChina
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The First Affiliated Hospital of Soochow UniversityNot yet recruitingPhiladelphia-Positive ALLChina
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M.D. Anderson Cancer CenterAscentage Pharma Group Inc.Not yet recruitingAdvanced Chronic Myeloid Leukemia | Philadelphia Chromosome-Positive Acute Myeloid LeukemiaUnited States
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Nanfang Hospital of Southern Medical UniversityRecruitingChronic Myeloid Leukemia in Myeloid Blast Crisis | Chronic Myeloid Leukaemia Transformation | Chronic Myeloid Leukemia - Accelerated Phase | Chronic Myeloid Leukemia in Lymphoid Blast CrisisChina
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Ascentage Pharma Group Inc.HealthQuest Pharma Inc.Recruiting
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Institute of Hematology & Blood Diseases HospitalNot yet recruitingMinimal Residual Disease | Bone Marrow Transplant | Ph+ ALLChina
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Nanfang Hospital, Southern Medical UniversityRecruitingAcute Lymphoblastic Leukemia | Philadelphia Chromosome | Adult ALL | Philadelphia-Positive ALL | IKZF1 Gene MutationChina
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Peking University People's HospitalHenan Cancer Hospital; Wuhan Union Hospital, China; Zhejiang University; Peking... and other collaboratorsNot yet recruitingChronic Myeloid LeukemiaChina