Newly-diagnosed Pediatric Ph-positive B-ALL Protocol
Recruiting
Phase 3
Interventional Study
Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)
Childhood Leukemia, Acute Lymphoblastic
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.
At a Glance
- Age
- 1 Month – 18
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 150 (estimated)
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China · Other
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About This Trial
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 blinatumomab, and the BCL-2 selective inhibitor venetoclax for newly diagnosed pediatric/adolescent patients with Ph+ ALL. The CCCG-Ph+ B-ALL-2025 protocol will be modified as following compared to the …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Must meet all items below:
1. Age older than 1 month to younger 18 years.
2. Newly diagnosed Philadelphia chromosome-positive or BCR::ABL1-positive B-ALL.
3. Written informed consent of the parents or other legally authorized guardian of the patient according to local law and r…
Contacts