New treatment approach for children newly diagnosed with T‑cell acute lymphoblastic leukemia using dasatinib, venetoclax, and homoharringtonine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter Phase 2/3 protocol run within the Chinese Children's Cancer Group that tests adding three targeted or cytotoxic agents to a modified CCCG-T‑ALL backbone. Non‑ETP patients receive dasatinib after the initial window and, if MRD ≥0.01% on day 46, are randomized to different homoharringtonine doses during early intensification. ETP/near‑ETP patients receive venetoclax in place of daunorubicin during induction and specified interim phases, and CAT is substituted in early intensification for selected patients. The protocol also reduces certain maintenance alkylator cycles to five to preserve fertility and adds drug sensitivity testing to guide therapy.

Why it matters

Who can join: the full rules

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 ≥14 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.

Where it's running

• Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
  Tianjin, Tianjin Municipality, China Recruiting
• Anhui Medical University Second Affiliated Hospital
  Hefei, Anhui, China Not yet recruiting
• Anhui Provincial Children's Hospital
  Hefei, Anhui, China Not yet recruiting
• Chongqing Medical University Affiliated Children's Hospital
  Chongqing, Chongqing Municipality, China Not yet recruiting
• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Not yet recruiting
• Guangzhou Women and Children's Medical Center
  Guangzhou, Guangdong, China Not yet recruiting

Study contacts

• Principal investigator: Xiaofan Zhu, MD — Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
• Study coordinator: Jingliao Zhang, MD
• Email: zhangjingliao@ihcams.ac.cn
• Phone: +86 22 23909196

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.