Status:
RECRUITING
Newly-diagnosed Pediatric Ph-positive B-ALL Protocol
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)
Childhood Leukemia, Acute Lymphoblastic
Eligibility:
All Genders
1-18 years
Phase:
PHASE3
Brief Summary
This prospective clinical trial evaluates the effectiveness and safety of "chemotherapy-light" regimen incorporating the third-generation TKI olverembatinib, the bi-specific CD3/CD19 T cell engager bl...
Detailed Description
1. All Ph+-ALL patients will uniformly use the 3rd generation of TKI olverembatinib (OVB) instead of dasatinib throughout the regimen. 2. OVB is combined with Vincristine and Prednisone (VP) during th...
Eligibility Criteria
Inclusion
- Must meet all items below:
- Age older than 1 month to younger 18 years.
- Newly diagnosed Philadelphia chromosome-positive or BCR::ABL1-positive B-ALL.
- Written informed consent of the parents or other legally authorized guardian of the patient according to local law and regulations.
Exclusion
- Should be excluded if had any item below:
- ALL evolved from CML.
- Known underlying congenital immunodeficiency or metabolic disease.
- Congenital heart disease with cardiac insufficiency.
- Gastrointestinal dysfunction or gastrointestinal diseases that may significantly alter the absorption of study drug.
- Severe malnutrition, uncontrolled active infections, or serious cardiovascular diseases.
- Subjects with significant CNS disorder (e.g., uncontrolled seizure disorder, autoimmune disease involving CNS).
- Treated with glucocorticoids for ≥14 days, or targeted inhibitor for \> 7 days within one month before enrollment, or any chemotherapy or any systemic anticancer therapy (including but not limited to any TKI) or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression).
- Any significant comorbidities or psychiatric disorders that may impact patient safety, compliance, informed consent, study participation, follow-up, or the interpretation of study results. In such cases, all participating sites must report directly to the PI to determine whether the patient meets exclusion criteria.
Key Trial Info
Start Date :
March 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07152041
Start Date
March 28 2025
End Date
June 1 2030
Last Update
September 3 2025
Active Locations (24)
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1
Anhui Medical University Second Affiliated Hospita
Hefei, Anhui, China
2
Chongqing Medical University Affiliated Children's Hospital
Chongqing, Chongqing Municipality, China
3
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
4
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China