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Newly-diagnosed Pediatric Ph-positive B-ALL Protocol

RecruitingPhase 3Ages 1 Month - 18 YearsAllInstitute of Hematology & Blood Diseases Hospitalโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 regulations. Exclusion Criteria: Should be excluded if had any item below: 1. ALL evolved from CML. 2. Known underlying congenital immunodeficiency or metabolic disease. 3. Congenital heart disease with cardiac insufficiency. 4. Gastrointestinal dysfunction or gastrointestinal diseases that may significantly alter the absorption of study drug. 5. Severe malnutrition, uncontrolled active infections, or serious cardiovascular diseases. 6. Subjects with significant CNS disorder (e.g., uncontrolled seizure disorder, autoimmune disease involving CNS). 7. Treated with glucocorticoids for โ‰ฅ14 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). 8. 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.
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What it tests

  • olverembatinib
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Where

24 sites
Anhui Medical University Second Affiliated Hospita
Hefei, China
Chongqing Medical University Affiliated Children's Hospital
Chongqing, China
Fujian Medical University Union Hospital
Fuzhou, China
Guangzhou Women and Children's Medical Center
Guangzhou, China
Nanfang Hospital, Southern Medical University
Guangzhou, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, China
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China

โ€ฆand 16 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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