Actively Recruiting

Phase 2
Phase 3
Age: 1Month - 18Years
All Genders
NCT06764238

Newly-diagnosed Intermediate/High Risk Pediatric B-cell ALL Protocol

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-02-07

1800

Participants Needed

26

Research Sites

334 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Building upon the results from the CCCG-ALL-2015, CCCG-ALL-2020 multicenter study cohort, concurrent research findings, and the latest clinical trials, the CCCG-ALL-2025 I/HR-B-ALL is thus developed to further improve the event-free survival (EFS), and overall survival (OS), and quality of life (QoL) of children with intermediate- and high- risk B-cell childhood acute lymphoblastic leukaemia (I/HR-B-ALL), while decreasing adverse reactions and transplantation rates. This trial primarily aims to explore: 1. The efficacy of two randomized Blinatumomab application scheme on I/HR-ALL as determined by MRD negatvitiy rate. 2. The efficacy of modified mini-hyperCVD + Venetoclax in I/HR-ALL cannot afford blinatumomab, in contrast to historical control as determined by MRD negatvitiy rate.

CONDITIONS

Official Title

Newly-diagnosed Intermediate/High Risk Pediatric B-cell ALL Protocol

Who Can Participate

Age: 1Month - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age older than 1 month to younger than 18 years
  • Diagnosis of acute lymphoblastic leukemia confirmed by bone marrow morphology
  • Diagnosis of B-cell acute lymphoblastic leukemia by immunophenotyping
Not Eligible

You will not qualify if you...

  • Low-risk acute lymphoblastic leukemia
  • sIgM positive status
  • Acute leukemias of ambiguous lineage as per WHO or EGIL criteria
  • Acute lymphoblastic leukemia 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
  • Treatment with glucocorticoids for 14 days or more, ABL kinase inhibitors for over 7 days within one month before enrollment, or any chemotherapy/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

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Trial Site Locations

Total: 26 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

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Not Yet Recruiting

4

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China

Not Yet Recruiting

5

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Not Yet Recruiting

6

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Not Yet Recruiting

7

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Not Yet Recruiting

8

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

Wuhan, Hubei, China

Not Yet Recruiting

9

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

Wuhan, Hubei, China

Not Yet Recruiting

10

Wuhan Children's Hospital

Wuhan, Hubei, China

Not Yet Recruiting

11

Hunan Children's Hospital

Changsha, Hunan, China

Not Yet Recruiting

12

Xiangya Hospital Central South University

Changsha, Hunan, China

Not Yet Recruiting

13

Nanjing Children's Hospital Affiliated to Nanjing Medical University

Nanjing, Jiangsu, China

Not Yet Recruiting

14

Children's Hospital of Soochow University

Suzhou, Jiangsu, China

Not Yet Recruiting

15

Jiangxi Provincial Children's Hospital

Nanchang, Jiangxi, China

Not Yet Recruiting

16

Qilu Hospital of Shandong University

Jinan, Shandong, China

Not Yet Recruiting

17

Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Not Yet Recruiting

18

Xi'an Northwest Women and Children Hospital

Xi’an, Shanxi, China

Not Yet Recruiting

19

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, China

Not Yet Recruiting

20

Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC

Tianjin, Tianjin Municipality, China, 300020

Actively Recruiting

21

Chongqing Medical University Affiliated Children's Hospital

Chongqing, China

Not Yet Recruiting

22

Children's Hospital of Fudan University

Shanghai, China

Not Yet Recruiting

23

Shanghai Children's Hospital

Shanghai, China

Not Yet Recruiting

24

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

Shanghai, China

Not Yet Recruiting

25

Shenzhen Children's Hospital

Shenzhen, China

Not Yet Recruiting

26

Hong Kong Children's Hospital

Hong Kong, Hong Kong

Not Yet Recruiting

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Research Team

J

Jingliao Zhang, MD

CONTACT

X

Xiaofan Zhu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Newly-diagnosed Intermediate/High Risk Pediatric B-cell ALL Protocol | DecenTrialz