Actively Recruiting

Phase 2
Phase 3
Age: 1Month - 18Years
All Genders
ID06855810

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

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

610

Participants Needed

27

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether adding three new drugs—dasatinib, venetoclax, and homoharringtonine—to current treatment can improve outcomes for children newly diagnosed with T-cell acute lymphoblastic leukemia (T-ALL). This study is conducted across multiple centers within the Chinese Children's Cancer Group and focuses on increasing remission rates, enhancing event-free survival, and lowering relapse rates. The treatment plan varies by patient subgroup. All children receive dexamethasone during induction therapy. For patients with early T-cell precursor (ETP) or near-ETP T-ALL, venetoclax replaces daunorubicin in induction and interim therapies, with changes to chemotherapy regimens to reduce fertility impact. Non-ETP patients receive dasatinib after an initial phase, with some randomized to different doses of homoharringtonine during intensification and reinduction therapies. Maintenance therapy includes adjusted chemotherapy cycles to lessen long-term effects. Participants undergo regular assessments including bone marrow tests to measure minimal residual disease (MRD) and monitor response to treatment. Researchers track remission rates, event-free survival, relapse incidence, and treatment side effects over approximately 5 to 6.5 years. Drug sensitivity testing is also added to help guide treatment choices. Safety is closely monitored during and after treatment to assess adverse events and overall outcomes.

CONDITIONS

Brief 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 confirmed by bone marrow morphology
  • Diagnosis of T-cell acute lymphoblastic leukemia confirmed by immunophenotyping
Not Eligible

You will not qualify if you...

  • Diagnosis of B-cell acute lymphoblastic leukemia (B-ALL)
  • Diagnosis of acute myeloid leukemia (AML)
  • Acute leukemias of ambiguous lineage as defined by WHO or EGIL criteria
  • Acute lymphoblastic leukemia evolved from chronic myeloid leukemia (CML)
  • Down's syndrome or major congenital or hereditary disease causing 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 more than 7 days within one month before enrollment
  • Any chemotherapy or radiotherapy within 3 months before enrollment except emergency radiotherapy for airway compression
  • Significant comorbidities or psychiatric disorders impacting safety or study participation
  • Severe malnutrition, active infections, heart failure, or chemotherapy intolerance

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to approximately 5 years

Participants receive induction therapy with dexamethasone. Depending on their T-ALL subtype, participants receive additional drugs such as venetoclax, dasatinib, or homoharringtonine during induction and subsequent therapy phases including early intensification, interim therapies, reinduction, and maintenance therapy.

Multiple visits during induction, early intensification, interim, reinduction, and maintenance therapy phases

Follow-up

Duration - Up to approximately 1.5 years after treatment completion

Participants are monitored for treatment outcomes including event-free survival, overall survival, relapse incidence, and adverse events after completing treatment.

Periodic visits during follow-up period

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

X

Xiaofan Zhu, MD

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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Published Research Related To This Trial

Children's Oncology Group Trial AALL1231: A Phase III Clinical Trial Testing Bortezomib in Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia and Lymphoma.

David T Teachey, Meenakshi Devidas, Brent L Wood...

https://pubmed.ncbi.nlm.nih.gov/35271306

Dasatinib-therapy induced sustained remission in a child with refractory TCF7-SPI1 T-cell acute lymphoblastic leukemia.

Yingyi He, Jingliao Zhang, Yingchi Zhang...

https://pubmed.ncbi.nlm.nih.gov/35441457

NGS-based stratification refines the risk stratification in T-ALL and identifies a very-high-risk subgroup of patients.

Mathieu Simonin, Loïc Vasseur, Etienne Lengliné...

https://pubmed.ncbi.nlm.nih.gov/38848537

Augmented post-remission therapy for a minimal residual disease-defined high-risk subgroup of children and young people with clinical standard-risk and intermediate-risk acute lymphoblastic leukaemia (UKALL 2003): a randomised controlled trial.

Ajay Vora, Nick Goulden, Chris Mitchell...

https://pubmed.ncbi.nlm.nih.gov/24924991

Late MRD response determines relapse risk overall and in subsets of childhood T-cell ALL: results of the AIEOP-BFM-ALL 2000 study.

Martin Schrappe, Maria Grazia Valsecchi, Claus R Bartram...

https://pubmed.ncbi.nlm.nih.gov/21719599