Actively Recruiting

Phase 2
Phase 3
Age: 1Month - 18Years
All Genders
NCT06855810

Newly-diagnosed Pediatric T-cell ALL Protocol

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-26

610

Participants Needed

27

Research Sites

324 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Newly-diagnosed Pediatric T-cell ALL Protocol

Who Can Participate

Age: 1Month - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age older than 1 month to younger than 18 years
  • Diagnosis of acute lymphoblastic leukemia by bone marrow morphology
  • Diagnosis of T-cell acute lymphoblastic leukemia by immunophenotyping
Not Eligible

You will not qualify if you...

  • Diagnosis of B-cell acute lymphoblastic leukemia
  • Diagnosis of acute myeloid leukemia
  • Acute leukemias of ambiguous lineage by WHO or EGIL criteria
  • Acute lymphoblastic leukemia evolved from chronic myeloid leukemia
  • Down's syndrome or major congenital/hereditary disease with organ dysfunction
  • Secondary leukemia
  • Known congenital immunodeficiency or metabolic disease
  • Congenital heart disease with cardiac insufficiency
  • Treatment with glucocorticoids for 14 days or more, or ABL kinase inhibitors for over 7 days within 1 month before enrollment
  • Chemotherapy or radiotherapy within 3 months before enrollment (except emergency radiotherapy for airway compression)
  • Significant comorbidities or psychiatric disorders affecting safety or compliance
  • Severe malnutrition, active infections, heart failure, or chemotherapy intolerance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 27 locations

1

Anhui Medical University Second Affiliated Hospital

Hefei, Anhui, China

Not Yet Recruiting

2

Anhui Provincial Children's Hospital

Hefei, Anhui, China

Not Yet Recruiting

3

Chongqing Medical University Affiliated Children's Hospital

Chongqing, Chongqing Municipality, China

Not Yet Recruiting

4

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Not Yet Recruiting

5

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China

Not Yet Recruiting

6

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Not Yet Recruiting

7

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Not Yet Recruiting

8

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Not Yet Recruiting

9

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Not Yet Recruiting

10

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Not Yet Recruiting

11

Wuhan Children's Hospital

Wuhan, Hubei, China

Not Yet Recruiting

12

Hunan Children's Hospital

Changsha, Hunan, China

Not Yet Recruiting

13

The Third Xiangya Hospital of the Central South University

Changsha, Hunan, China

Not Yet Recruiting

14

Xiangya Hospital Central South University

Changsha, Hunan, China

Not Yet Recruiting

15

Nanjing Children's Hospital Affiliated to Nanjing Medical University

Nanjin, Jiangsu, China

Not Yet Recruiting

16

Children's Hospital of Soochow University

Suzhou, Jiangsu, China

Not Yet Recruiting

17

Jiangxi Provincial Children's Hospital

Nanchang, Jiangxi, China

Not Yet Recruiting

18

Qilu Hospital of Shandong University

Jinan, Shandong, China

Not Yet Recruiting

19

Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Not Yet Recruiting

20

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Not Yet Recruiting

21

Shanghai Children's Hospital

Shanghai, Shanghai Municipality, China

Not Yet Recruiting

22

Shanghai Children's Medical Cener, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Not Yet Recruiting

23

Xi'an Northwest Women and Children Hospital

Xi’an, Shanxi, China

Not Yet Recruiting

24

Shenzhen Children's Hospital

Shenzhen, Shenzhen, China

Not Yet Recruiting

25

West China Second University Hospital

Chengdu, Sichuan, China

Not Yet Recruiting

26

Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC

Tianjin, Tianjin Municipality, China

Actively Recruiting

27

Hong Kong Children's Hospital

Hong Kong, Hong Kong, Hong Kong

Not Yet Recruiting

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Research Team

J

Jingliao Zhang, MD

CONTACT

X

Xiaofan Zhu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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