RecruitingPhase 3

Newly-diagnosed Pediatric Ph-positive B-ALL Protocol

China150 participantsStarted 2025-03-28

Plain-language 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 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

Who can participate

Age range1 Month – 18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Day 48 end-of-induction measurable residual diseases (MRD48) after induction remission with olverembatinib and blinatumomab, compared to MRD46 of those treated with dasatinib plus chemotherapy induction (CCCG-ALL-2015 /2020) or from historical cohorts .

Timeframe: Up to approximately 4.5 years.

Trial details

NCT IDNCT07152041

SponsorInstitute of Hematology & Blood Diseases Hospital, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12

Contact for this trial

Jingliao Zhang, MD

+86 22 23909196 zhangjingliao@ihcams.ac.cn

View on ClinicalTrials.gov More Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+) trials