Pharmacotypes across the genomic landscape of pediatric acute lymphoblastic leukemia and impact on treatment response.
Shawn H R Lee, Wenjian Yang, Yoshihiro Gocho...
https://pubmed.ncbi.nlm.nih.gov/36604538Actively Recruiting
Phase 2
Phase 3
Age: 1Year - 18Years
All Genders
ID06882057
Chinese Children's Cancer Group-2025 Protocol for Newly Diagnosed Low Risk Childhood B-cell Acute Lymphoblastic Leukemia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-26
3000
Participants Needed
27
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment plan called CCCG-ALL2025 for children with newly diagnosed low-risk B-cell acute lymphoblastic leukemia (ALL). This plan builds on previous protocols and uses blinatumomab (Blina-14) as an early intensification treatment after initial therapy, regardless of the patient's measurable residual disease (MRD) status. The study aims to compare the effectiveness of chemotherapy combined with Blina-14 to previous treatments, with adjustments to maintenance therapy based on deep remission measured by next-generation sequencing (Ig-NGS MRD).
CONDITIONS
Brief Title
Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol
Who Can Participate
Age: 1Year - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age older than 1 year and younger than 18 years
- Diagnosis of acute lymphoblastic leukemia by bone marrow morphology
- Diagnosis of B-cell acute lymphoblastic leukemia by immunophenotyping
- Classified as low risk group
You will not qualify if you...
- Diagnosis of T-cell acute lymphoblastic leukemia
- Intermediate or high risk B-cell acute lymphoblastic leukemia group
- Presence of sIgM+
- Acute leukemias of ambiguous lineage by WHO or EGIL criteria
- Philadelphia chromosome positive ALL (Ph-ALL)
- ALL evolved from chronic myeloid leukemia
- Down's syndrome or major congenital/hereditary disease with organ dysfunction
- Secondary leukemia
- Known congenital immunodeficiency or metabolic disease
- Congenital heart disease with cardiac insufficiency
- Glucocorticoid treatment for 14 days or more, or ABL kinase inhibitors for over 7 days within one month before enrollment
- Any chemotherapy or radiotherapy within 3 months before enrollment (except emergency radiotherapy to relieve airway compression)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Early Intensification with Blinatumomab
Duration - 14 days
Participants receive 14 days of blinatumomab as early intensification treatment to replace previous therapy.
1 visit at start and bone marrow aspiration at Day 60
Consolidation Phase with HD-MTX
Duration - Approximately 4 weeks
Participants receive two courses of high-dose methotrexate (HD-MTX) as consolidation therapy, including two triple intrathecal therapy treatments.
Multiple visits during consolidation including 2 intrathecal treatments
Second Blinatumomab Course
Duration - 14 days
Participants receive a second 14-day course of blinatumomab after completion of HD-MTX consolidation.
1 visit for infusion
Reinduction and Maintenance Phases
Duration - Varies by participant MRD status, ranging from 32 to 72 weeks
Participants undergo reinduction and maintenance therapy phases, which differ by participant MRD status, including possible omission of Reinduction-2 and adjusted maintenance duration and intensity.
Repeated visits for chemotherapy cycles and intrathecal treatments depending on assigned maintenance regimen
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
Nanjing, 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 Hospita
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
X
Xiaofan Zhu, MD
J
Jingliao Zhang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Minimal residual disease detection by next-generation sequencing of different immunoglobulin gene rearrangements in pediatric B-ALL.
Haipin Chen, Miner Gu, Juan Liang...
https://pubmed.ncbi.nlm.nih.gov/37978187Detecting measurable residual disease beyond 10-4 by an IGHV leader-based NGS approach improves prognostic stratification in CLL.
Paul J Hengeveld, Michèle Y van der Klift, P Martijn Kolijn...
https://pubmed.ncbi.nlm.nih.gov/36084320NGS better discriminates true MRD positivity for the risk stratification of childhood ALL treated on an MRD-based protocol.
Michael Svaton, Aneta Skotnicova, Leona Reznickova...
https://pubmed.ncbi.nlm.nih.gov/36240445Identifying IGH disease clones for MRD monitoring in childhood B-cell acute lymphoblastic leukemia using RNA-Seq.
Zhenhua Li, Nan Jiang, Evelyn Huizi Lim...
https://pubmed.ncbi.nlm.nih.gov/32099036Long-Term Results of the Dasatinib-Blinatumomab Protocol for Adult Philadelphia-Positive ALL.
Robin Foà, Renato Bassan, Loredana Elia...
https://pubmed.ncbi.nlm.nih.gov/38127722Children's Oncology Group AALL1331: Phase III Trial of Blinatumomab in Children, Adolescents, and Young Adults With Low-Risk B-Cell ALL in First Relapse.
Laura E Hogan, Patrick A Brown, Lingyun Ji...
https://pubmed.ncbi.nlm.nih.gov/37257143Blinatumomab for MRD-Negative Acute Lymphoblastic Leukemia in Adults.
Mark R Litzow, Zhuoxin Sun, Ryan J Mattison...
https://pubmed.ncbi.nlm.nih.gov/39047240Blinatumomab Added to Chemotherapy in Infant Lymphoblastic Leukemia.
Inge M van der Sluis, Paola de Lorenzo, Rishi S Kotecha...
https://pubmed.ncbi.nlm.nih.gov/37099340Dasatinib-Blinatumomab for Ph-Positive Acute Lymphoblastic Leukemia in Adults.
Robin Foà, Renato Bassan, Antonella Vitale...
https://pubmed.ncbi.nlm.nih.gov/33085860