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/35271306Actively Recruiting
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-26
610
Participants Needed
27
Research Sites
52 weeks
Total Duration
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
Newly-diagnosed Pediatric T-cell ALL Protocol
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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
J
Jingliao Zhang, MD
X
Xiaofan Zhu, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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