Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol

Recruiting now · Phase 2/Phase 3

Conditions studied: Acute Lymphoblastic Leukemia ALL, Childhood Leukemia, Acute Lymphoblastic, B Cell Acute Lymphoblastic Leukemia (B-ALL)

In brief

CCCG-ALL2025 LR-B-ALL plan is designed based on the CCCG-ALL2020 plan. This is a clinical trial using 14 days of blinatumomab (Blina-14) as early intensification after induction therapy and 2nd Blina-14 in consolidation therapy in all newly diagnosed provisional low-risk (LR) pediatric acute lymphoblastic leukemia (ALL) patients, regardless of measurable residual diseases (MRD) status. We will compare the efficacy of chemotherapy combined with Blina-14, comparing to CAT+ intensification or historical regimens. Patients with early remission in depth will receive chemo-light late intensification and maintenance therapy afterwards. Early complete remission in depth and maintenance reduction will be determined by next-generation sequencing (Ig-NGS MRD).

Key facts

Study ID

NCT06882057

Run by

Institute of Hematology & Blood Diseases Hospital, China

People needed

3000

Starts

2025-03-03

Expected to finish

2033-06-01

Last updated by the study team

2025-08-26

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must meet all items below:
• Age older than 1 year and younger than 18 years.
• Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
• Diagnosis of B-ALL by immunophenotyping.
• Low risk group

You may not qualify if…

• Should be excluded in the presence of any item below:
• T-ALL
• I/HR B-ALL group
• sIgM+
• Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.
• Philadelphia chromosome positive ALL (Ph-ALL)
• ALL evolved from chronic myeloid leukemia (CML).
• Down's syndrome, or major congenital or hereditary disease with organ dysfunction
• Secondary leukemia
• Known underlying congenital immunodeficiency or metabolic disease
• Congenital heart disease with cardiac insufficiency.
• Glucocorticoid treatment for ≥14 days, or ABL kinase inhibitors for > 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression)

Where it is running

• Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC — Tianjin, Tianjin Municipality, China (enrolling)
• Anhui Provincial Children's Hospital — Hefei, Anhui, China
• Chongqing Medical University Affiliated Children's Hospital — Chongqing, Chongqing Municipality, China
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China
• Guangzhou Women and Children's Medical Center — Guangzhou, Guangdong, China
• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China
• The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning, Guangxi, China
• The Affiliated Hospital of Guizhou Medical University — Guiyang, Guizhou, China
• Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China
• Union Hospital of Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China
• Wuhan Children's Hospital — Wuhan, Hubei, China
• Hunan Children's Hospital — Changsha, Hunan, China
• The Third Xiangya Hospital of the Central South University — Changsha, Hunan, China
• Xiangya Hospital Central South University — Changsha, Hunan, China
• Nanjing Children's Hospital Affiliated to Nanjing Medical University — Nanjing, Jiangsu, China
• Children's Hospital of Soochow University — Suzhou, Jiangsu, China
• Jiangxi Provincial Children's Hospital — Nanchang, Jiangxi, China
• Qilu Hospital of Shandong University — Jinan, Shandong, China
• Affiliated Hospital of Qingdao University — Qingdao, Shandong, China
• Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China
• Shanghai Children's Hospital — Shanghai, Shanghai Municipality, China
• Shanghai Children's Medical Cener, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China
• Xi'an Northwest Women and Children Hospital — Xi’an, Shanxi, China
• Shenzhen Children's Hospita — Shenzhen, Shenzhen, China
• West China Second University Hospital — Chengdu, Sichuan, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.