Newly-diagnosed Pediatric Ph-positive B-ALL Protocol

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-18
SponsorInstitute of Hematology & Blood Diseases Hospital, China

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 CCCG-ALL-2020 protocol

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • olverembatinib

Treatment groups

150 Participants
are divided into 1 treatment group