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

Chinese Children's Cancer Group T-cell Acute Lymphoblastic Leukemia -2025 Project

This study will try adding dasatinib, venetoclax, and homoharringtonine to standard chemotherapy for children and adolescents newly diagnosed with T‑cell acute lymphoblastic leukemia to see if it increases deep (MRD‑negative) remissions and lowers relapse.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 610 (estimated)
• Ages: 1 Month to 18 Years
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (other)
• Drugs / interventions: chemotherapy, dasatinib
• Locations: 27 sites (Hefei, Anhui and 26 other locations)
• Trial ID: NCT06855810 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Children and adolescents older than 1 month and younger than 18 years with newly diagnosed T‑cell ALL confirmed by immunophenotyping and without recent prolonged corticosteroid or kinase‑inhibitor exposure are ideal candidates.

Not a fit: Patients with B‑ALL, AML, ambiguous‑lineage leukemias, those with significant congenital disorders (e.g., Down syndrome) or organ dysfunction, secondary leukemias, or recent extensive chemotherapy/radiation are not eligible and therefore unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could increase deep remission rates, extend event‑free survival, and reduce relapse in pediatric T‑ALL.

How similar studies have performed: Individual agents such as dasatinib and venetoclax have shown promise in early‑phase or niche T‑ALL/ETP settings, but combining these agents with homoharringtonine in a frontline pediatric protocol is relatively novel and not yet validated in large trials.

Eligibility criteria

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 this trial is running

Hefei, Anhui and 26 other locations

• 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)
• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (NOT_YET_RECRUITING)
• The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning, Guangxi, China (NOT_YET_RECRUITING)
• The Affiliated Hospital of Guizhou Medical University — Guiyang, Guizhou, China (NOT_YET_RECRUITING)
• Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (NOT_YET_RECRUITING)
• Union Hospital of Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (NOT_YET_RECRUITING)
• Wuhan Children's Hospital — Wuhan, Hubei, China (NOT_YET_RECRUITING)
• Hunan Children's Hospital — Changsha, Hunan, China (NOT_YET_RECRUITING)
• The Third Xiangya Hospital of the Central South University — Changsha, Hunan, China (NOT_YET_RECRUITING)
• Xiangya Hospital Central South University — Changsha, Hunan, China (NOT_YET_RECRUITING)
• Nanjing Children's Hospital Affiliated to Nanjing Medical University — Nanjin, Jiangsu, China (NOT_YET_RECRUITING)
• Children's Hospital of Soochow University — Suzhou, Jiangsu, China (NOT_YET_RECRUITING)
• Jiangxi Provincial Children's Hospital — Nanchang, Jiangxi, China (NOT_YET_RECRUITING)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (NOT_YET_RECRUITING)
• Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (NOT_YET_RECRUITING)
• Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China (NOT_YET_RECRUITING)
• Shanghai Children's Hospital — Shanghai, Shanghai Municipality, China (NOT_YET_RECRUITING)
• Shanghai Children's Medical Cener, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (NOT_YET_RECRUITING)
• Xi'an Northwest Women and Children Hospital — Xi’an, Shanxi, China (NOT_YET_RECRUITING)
• Shenzhen Children's Hospital — Shenzhen, Shenzhen, China (NOT_YET_RECRUITING)
• West China Second University Hospital — Chengdu, Sichuan, China (NOT_YET_RECRUITING)
• Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC — Tianjin, Tianjin Municipality, China (RECRUITING)
• Hong Kong Children's Hospital — Hong Kong, Hong Kong, Hong Kong (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Xiaofan Zhu, MD — Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
• Study coordinator: Jingliao Zhang, MD

Conditions: Acute Lymphoblastic Leukemia, Childhood Leukemia, Acute Lymphoblastic, T Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma, dasatinib, venetoclax, homoharringtonine