No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
350 (estimated)
Sponsor
Ascentage Pharma Group Inc. · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
A global multicenter, open-label, randomized and registrational Phase 3 study to evaluate efficacy and safety of olverembatinib combined with chemotherapy versus investigator's choice of tyrosine kinase inhibitor (TKI) combined with chemotherapy in subjects with newly-diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL).
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
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 centra…
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.