Newly-diagnosed Pediatric T-cell ALL Protocol

Recruiting now · Phase 2/Phase 3

Conditions studied: Acute Lymphoblastic Leukemia, Childhood Leukemia, Acute Lymphoblastic, T Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma

In brief

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).

Key facts

Study ID

NCT06855810

Run by

Institute of Hematology & Blood Diseases Hospital, China

People needed

610

Starts

2025-03-11

Expected to finish

2031-06-01

Last updated by the study team

2025-08-26

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age older than 1 month to younger than 18 years.
• Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
• Diagnosis of T-ALL by immunophenotyping.

You may not qualify if…

• B-ALL
• AML
• Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.
• ALL evolved from chronic myeloid leukemia (CML).
• Down's syndrome, or major congenital or hereditary disease with organ dysfunction
• Secondary leukemia
• Known underlying congenital immunodeficiency or metabolic disease
• Congenital heart disease with cardiac insufficiency.
• 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)
• 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.
• Severe malnutrition, active infections, heart failure, or chemotherapy intolerance.

Where it is running

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

Full record on ClinicalTrials.gov

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