Actively Recruiting
Chemotherapy With Targeted-Immunotherapy for Newly Diagnosed Ph+ ALL
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-05-13
110
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, open-label, randomized controlled trial to evaluate the efficacy of low-intensity chemotherapy combined with venetoclax and blinatumomab in newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Patients will be randomized to receive or not receive venetoclax during the first three cycles of induction and consolidation therapy. All patients receive olverembatinib (a third-generation TKI) continuously and may receive up to 4 cycles of blinatumomab starting from the fourth cycle. The primary endpoint is the rate of BCR::ABL1 ≤0.01% at 90 days and event-free survival (EFS). Secondary endpoints include overall survival (OS), relapse-free survival (RFS), molecular relapse rate, MRD negativity rate by NGS, and cardiovascular events.
CONDITIONS
Official Title
Chemotherapy With Targeted-Immunotherapy for Newly Diagnosed Ph+ ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed acute lymphoblastic leukemia with Philadelphia chromosome or BCR::ABL1 positivity confirmed by PCR or FISH
- Age 14 years or older
- ECOG performance status 0 to 2
- Adequate organ function: total bilirubin less than 1.5 times upper limit, AST/ALT less than 2.5 times upper limit, serum creatinine less than 2 times upper limit, cardiac enzymes less than 2 times upper limit, serum amylase less than 1.5 times upper limit, left ventricular ejection fraction above 45%
- Male and female patients of childbearing potential must agree to use effective contraception
- Signed informed consent
You will not qualify if you...
- Diagnosis of chronic myeloid leukemia in any phase
- Prior systemic anti-leukemic treatment for ALL except corticosteroids or hydroxyurea before enrollment
- Heart attack within 12 months before enrollment or uncontrolled serious heart conditions
- Uncontrolled active severe infection
- Active psychiatric illness that may interfere with treatment or consent
- Any other condition considered unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
H
Hui Wei, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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