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Newly-diagnosed Pediatric T-cell ALL Protocol

RecruitingPhase 2, Phase 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 is a prospective, multicenter study conducted within the Chinese Children's Cancer Group (CCCG). The study aims to evaluate whether the addition of three novel agents, dasatinib, venetoclax and homoharringtonine, can improve the minimal residual disease (MRD)-negative remission rate, enhance event-free survival (EFS), and reduce the cumulative incidence of relapse (CIR) in pediatric patients with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL).

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

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age older than 1 month to younger than 18 years. 2. Diagnosis of acute lymphoblastic leukemia by bone marrow morphology. 3. Diagnosis of T-ALL by immunophenotyping. Exclusion Criteria: 1. B-ALL 2. AML 3. Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria. 4. ALL evolved from chronic myeloid leukemia (CML). 5. Down's syndrome, or major congenital or hereditary disease with organ dysfunction 6. Secondary leukemia 7. Known underlying congenital immunodeficiency or metabolic disease 8. Congenital heart disease with cardiac insufficiency. 9. Treated with glucocorticoids for โ‰ฅ14 days, or ABL kinase inhibitors for \> 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression) 10. 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. 11. Severe malnutrition, active infections, heart failure, or chemotherapy intolerance.
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What it tests

  • Venetoclax
  • Dasatinib
  • homoharringtonine
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Where

27 sites
Anhui Medical University Second Affiliated Hospital
Hefei, China
Anhui Provincial Children's Hospital
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 People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, China

โ€ฆand 19 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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