Study on Olverembatinib for Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
Sponsor: Ascentage Pharma Group Inc.
ClinicalTrials ID:NCT06051409
This clinical trial is testing the effectiveness and safety of a new drug, olverembatinib, combined with chemotherapy, compared to other standard treatments for patients newly diagnosed with Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL).
Patient Parameters
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Program Overview
The purpose of this study is to compare the effectiveness and safety of a new treatment using olverembatinib with chemotherapy against the usual treatment options chosen by doctors for patients with newly diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL). This is a global study involving multiple centers and is open to eligible participants.
Description
This study is designed to evaluate how well the new drug olverembatinib works when combined with chemotherapy, compared to the standard treatment options chosen by doctors, which also involve chemotherapy. The study aims to determine which treatment is more effective and safer for patients with newly diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL). Participants will be randomly assigned to receive either the new treatment or the standard treatment, and their health outcomes will be closely monitored.
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed with Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL).
- Expected to live for at least 3 more months.
- In relatively good health with an ECOG performance status of 2 or lower, meaning fully active or able to carry out light work.
- Have adequate organ function as determined by medical tests.
Exclusion Criteria
- Have a history of chronic myeloid leukemia (CML).
- Have signs of leukemia affecting the brain or other areas outside the bone marrow, except for enlarged lymph nodes or liver/spleen.
- Have current or past diseases affecting the brain or nervous system.
- Have autoimmune diseases that might affect the brain.
- Are taking high doses of blood thinners or medications that affect blood clotting; low doses are allowed.
- Are using medications that interact with the study drug within a week before starting the study.
- Have uncontrolled heart diseases.
- Have had blood clots in the veins or lungs in the past 6 months.
- Are using medications that are not allowed in the study.
- Have unstable medical conditions that might affect safety or participation in the study.
- Are taking medications that can cause heart rhythm problems.
- Have active infections needing treatment.
- Have conditions affecting the ability to take or absorb oral medications, or have active stomach ulcers.
- Cannot use glucocorticoids due to medical reasons.
- Have bleeding disorders not related to leukemia.
- Plan to have major surgery.
- Are allergic to ingredients in the study drugs.
- Are pregnant, breastfeeding, or planning to become pregnant during the study.
- Have had other cancers within the past 2 years.
- Have any symptoms or conditions that might interfere with the study or are not suitable for participation.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Ascentage Investigative Site #1044 | 35233 | Birmingham | Alabama |
| Ascentage Investigative Site #1062 | 91010 | Duarte | California |
| Ascentage Investigative Site #1134 | 90048 | Los Angeles | California |
| Ascentage Investigative Site #1059 | 90095 | Los Angeles | California |
| Ascentage Investigative Site #1142 | 33155 | Miami | Florida |
| Ascentage Investigative Site #1045 | 30912 | Augusta | Georgia |
| Ascentage Investigative Site #1158 | 46202 | Indianapolis | Indiana |
| Ascentage Investigative Site #1069 | 46237 | Indianapolis | Indiana |
| Ascentage Investigative Site #1084 | 40536 | Lexington | Kentucky |
| Ascentage Investigative Site #1064 | 07601 | Hackensack | New Jersey |
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