Newly-diagnosed Pediatric T-cell ALL Protocol

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

610

Participants

Timeline

Start Date

March 11, 2025

Primary Completion Date

June 30, 2030

Study Completion Date

June 30, 2031

Conditions
Acute Lymphoblastic LeukemiaChildhood Leukemia, Acute LymphoblasticT Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma
Interventions
DRUG

Venetoclax

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.

DRUG

Dasatinib

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.

DRUG

homoharringtonine

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.

Trial Locations (27)

Unknown

NOT_YET_RECRUITING

Anhui Medical University Second Affiliated Hospital, Hefei

NOT_YET_RECRUITING

Anhui Provincial Children's Hospital, Hefei

NOT_YET_RECRUITING

Chongqing Medical University Affiliated Children's Hospital, Chongqing

NOT_YET_RECRUITING

Fujian Medical University Union Hospital, Fuzhou

NOT_YET_RECRUITING

Guangzhou Women and Children's Medical Center, Guangzhou

NOT_YET_RECRUITING

Nanfang Hospital, Southern Medical University, Guangzhou

NOT_YET_RECRUITING

The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning

NOT_YET_RECRUITING

The Affiliated Hospital of Guizhou Medical University, Guiyang

NOT_YET_RECRUITING

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

NOT_YET_RECRUITING

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

NOT_YET_RECRUITING

Wuhan Children's Hospital, Wuhan

NOT_YET_RECRUITING

Hunan Children's Hospital, Changsha

NOT_YET_RECRUITING

The Third Xiangya Hospital of the Central South University, Changsha

NOT_YET_RECRUITING

Xiangya Hospital Central South University, Changsha

NOT_YET_RECRUITING

Nanjing Children's Hospital Affiliated to Nanjing Medical University, Nanjin

NOT_YET_RECRUITING

Children's Hospital of Soochow University, Suzhou

NOT_YET_RECRUITING

Jiangxi Provincial Children's Hospital, Nanchang

NOT_YET_RECRUITING

Qilu Hospital of Shandong University, Jinan

NOT_YET_RECRUITING

Affiliated Hospital of Qingdao University, Qingdao

NOT_YET_RECRUITING

Children's Hospital of Fudan University, Shanghai

NOT_YET_RECRUITING

Shanghai Children's Hospital, Shanghai

NOT_YET_RECRUITING

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

NOT_YET_RECRUITING

Xi'an Northwest Women and Children Hospital, Xi’an

NOT_YET_RECRUITING

Shenzhen Children's Hospital, Shenzhen

NOT_YET_RECRUITING

West China Second University Hospital, Chengdu

RECRUITING

Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC, Tianjin

NOT_YET_RECRUITING

Hong Kong Children's Hospital, Hong Kong

All Listed Sponsors
lead

Institute of Hematology & Blood Diseases Hospital, China

OTHER