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

Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Hunan Children's Hospital
NOT_YET_RECRUITING
Changsha
The Third Xiangya Hospital of the Central South University
NOT_YET_RECRUITING
Changsha
Xiangya Hospital Central South University
NOT_YET_RECRUITING
Changsha
West China Second University Hospital
NOT_YET_RECRUITING
Chengdu
Chongqing Medical University Affiliated Children's Hospital
NOT_YET_RECRUITING
Chongqing
Fujian Medical University Union Hospital
NOT_YET_RECRUITING
Fuzhou
Guangzhou Women and Children's Medical Center
NOT_YET_RECRUITING
Guangzhou
Nanfang Hospital, Southern Medical University
NOT_YET_RECRUITING
Guangzhou
The Affiliated Hospital of Guizhou Medical University
NOT_YET_RECRUITING
Guiyang
Anhui Medical University Second Affiliated Hospital
NOT_YET_RECRUITING
Hefei
Anhui Provincial Children's Hospital
NOT_YET_RECRUITING
Hefei
Qilu Hospital of Shandong University
NOT_YET_RECRUITING
Jinan
Jiangxi Provincial Children's Hospital
NOT_YET_RECRUITING
Nanchang
Nanjing Children's Hospital Affiliated to Nanjing Medical University
NOT_YET_RECRUITING
Nanjin
The People's Hospital of Guangxi Zhuang Autonomous Region
NOT_YET_RECRUITING
Nanning
Affiliated Hospital of Qingdao University
NOT_YET_RECRUITING
Qingdao
Children's Hospital of Fudan University
NOT_YET_RECRUITING
Shanghai
Shanghai Children's Hospital
NOT_YET_RECRUITING
Shanghai
Shanghai Children's Medical Cener, Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITING
Shanghai
Shenzhen Children's Hospital
NOT_YET_RECRUITING
Shenzhen
Children's Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
RECRUITING
Tianjin
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Wuhan Children's Hospital
NOT_YET_RECRUITING
Wuhan
Xi'an Northwest Women and Children Hospital
NOT_YET_RECRUITING
Xi’an
Hong Kong Special Administrative Region
Hong Kong Children's Hospital
NOT_YET_RECRUITING
Hong Kong
Contact Information
Primary
Jingliao Zhang, MD
zhangjingliao@ihcams.ac.cn
+86 22 23909196
Backup
Xiaofan Zhu, MD
xfzhu@ihcams.ac.cn
+ 86 22 23909001
Time Frame
Start Date: 2025-03-11
Estimated Completion Date: 2031-06
Participants
Target number of participants: 610
Treatments
Experimental: (near)ETP-ALL
All T-ALL patients will receive 8 mg/m2/day dexamethasone in induction therapy. For all ETP/near-ETP T-ALL patients, venetoclax will replace daunorubicin in induction therapy. CAT will replace CAT+ during early intensification. Venetoclax will replace daunorubicin in interim therapy 2 and 4. In maintenance therapy 2, the CTX+Ara-C treatment cycles are reduced to 5, in order to minimize the impact of alkylating agents on fertility.
Experimental: nonETP-TALL-Das Group
All T-ALL patients will receive 8 mg/m2/day dexamethasone in induction therapy. All non-ETP T-ALL patients will receive dasatinib after initial window phase in induction therapy. For non-ETP T-ALL patients with MRD \<0.01% on day 46, CAT will replace CAT+ during early intensification, and patients will be continuously subjected to dasatinib combined with chemotherapy during early intensification, interim tharapy, reinduction therapy and maintenance therapy. In maintenance therapy 2, the CTX+Ara-C treatment cycles are reduced to 5, in order to minimize the impact of alkylating agents on fertility.
Experimental: nonETP-TALL-HHT Group
All T-ALL patients will receive 8 mg/m2/day dexamethasone in induction therapy. All non-ETP T-ALL patients will receive dasatinib after initial window phase in induction therapy. For non-ETP T-ALL patients with MRD ≥0.01% on day 46,CAT+ will be replaced with randomized doses of homoharringtonine (HHT) during early intensification, and HHT will be administrated during reinduction therapy. In maintenance therapy 2, the CTX+Ara-C treatment cycles are reduced to 5, in order to minimize the impact of alkylating agents on fertility.
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China

This content was sourced from clinicaltrials.gov