Evaluating Olverembatinib for Newly Diagnosed Ph+ ALL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 clinical trial is a global multicenter, open-label, randomized study designed to assess the efficacy and safety of Olverembatinib in combination with chemotherapy compared to Imatinib combined with chemotherapy in patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Participants will be randomly assigned to receive either the investigational drug Olverembatinib or the control drug Imatinib, both alongside standard chemotherapy. The study aims to determine which treatment provides better outcomes for patients with this specific type of leukemia.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL)
2. Expected survival of at least 3 months
3. ECOG ≤ 2
4. Adequate organ function

Exclusion Criteria:

1. A history of chronic myeloid leukemia (CML)
2. Clinical manifestations of central nervous system (CNS) leukemia or ALL extramedullary infiltration, except lymphadenopathy or hepatosplenomegaly
3. Previous or current clinical CNS diseases
4. Autoimmune diseases that may involve the CNS
5. Use of therapeutic doses of anticoagulants and/or antiplatelet agents; low doses of anticoagulants or antiplatelet agents are allowed
6. Use a therapeutic drug that has drug interaction with the investigational drug due to other diseases within 7 days or within 5 half-lives (whichever is shorter) prior to the first receipt of the investigational drug
7. Uncontrolled heart diseases
8. Any venous thromboembolism in the 6 months prior to randomization, including but not limited to deep vein thrombosis (DVT) or pulmonary embolism
9. Use of prohibited drugs
10. Disease or medical condition that is unstable or may affect its safety or compliance with the study
11. Use of medications known to cause prolonged QT interval
12. Active infections requiring systemic treatment
13. Disease that severely affects the oral administration and absorption of drugs, or an active gastrointestinal ulcer
14. Contraindications to the use of glucocorticoids
15. Bleeding disorders unrelated to ALL
16. Plan to undergo major surgery
17. Allergy to drug ingredients, excipients, or their analogues in the study
18. Female subjects who are pregnant or breastfeeding or expect to become pregnant during the study period
19. Other malignant tumors within 2 years
20. Any symptom or illness that may interfere with the evaluation of the efficacy and safety of the investigational drug, or any other condition or condition that is not appropriate for participation in the study

Where it's running

• Xinqiao Hospital of Army Medical University
  Chongqing, Chongqing Municipality, China Recruiting
• Guangdong Province People's Hospital
  Guangdong, Guangzhou, China Recruiting
• Nanfang Hospital of Southern Medical University
  Guangdong, Guangzhou, China Recruiting
• Henan Cancer Hospital
  Zhengzhou, Henan, China Recruiting
• Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting
• The First Affiliated Hospital of Suzhou University
  Suzhou, Jiangsu, China Recruiting

+40 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Elias Jabbour, M.D. — M.D. Anderson Cancer Center
• Study coordinator: Ascentage Clinical Operations
• Email: clinical-trials@ascentage.com
• Phone: 301-291-5658

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Olverembatinib plus APG-2575 for children with relapsed or refractory Philadelphia-positive ALL

  This study tests whether a combination of olverembatinib and APG-2575, with dexamethasone, is safe and potentially effective in children with relapsed or refractory Ph+ ALL who have already tried other TKIs.

  Recruiting Phase 1 Institute of Hematology & Blood Diseases Hospital, China · Hefei, Anhui and 3 other locations · NCT05495035

• Low-intensity chemotherapy with olverembatinib, venetoclax and blinatumomab for newly diagnosed Philadelphia chromosome–positive ALL

  This trial will test whether adding venetoclax to a low‑intensity chemotherapy plan together with continuous olverembatinib and planned blinatumomab helps people aged 14+ with newly diagnosed Ph+ ALL get deeper early molecular remission and live longer.

  Recruiting Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT07493161

• Asciminib in children and young adults with relapsed or refractory Ph+ or ABL-class Ph-like ALL

  This study tests asciminib in kids and young adults with relapsed or refractory Philadelphia-positive or ABL-class Ph-like ALL to see if it is safe and helps treat the leukemia.

  Recruiting at 4 sites Phase 1/2 Novartis · Sydney, New South Wales and 3 other locations · NCT07387926

• How olverembatinib is processed in people with liver impairment

  This test gives a single 20 mg dose of olverembatinib to people with different levels of chronic liver impairment and matched healthy volunteers to see how the drug is absorbed, distributed, metabolized, and cleared.

  Recruiting Phase 1 Ascentage Pharma Group Inc. · Suzhou, Jiangsu · NCT07282093

• ThisCART19A plus Olverembatinib for newly diagnosed Ph+ ALL

  A one-arm study tests whether ThisCART19A plus Olverembatinib can safely and effectively treat adults with newly diagnosed Philadelphia chromosome–positive ALL.

  Recruiting at 2 sites Early Phase 1 The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu and 1 other locations · NCT07074496

• Olverembatinib monotherapy for adults with newly diagnosed chronic-phase CML

  We are testing whether olverembatinib can control disease and produce deep molecular responses in adults newly diagnosed with chronic-phase CML.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT06817720

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.