Actively Recruiting

Phase 3
Age: 1Month - 18Years
All Genders
NCT07152041

Newly-diagnosed Pediatric Ph-positive B-ALL Protocol

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-09-03

150

Participants Needed

24

Research Sites

270 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This prospective clinical trial evaluates the effectiveness and safety of "chemotherapy-light" regimen incorporating the third-generation TKI olverembatinib, the bi-specific CD3/CD19 T cell engager blinatumomab, and the BCL-2 selective inhibitor venetoclax for newly diagnosed pediatric/adolescent patients with Ph+ ALL. The CCCG-Ph+ B-ALL-2025 protocol will be modified as following compared to the CCCG-ALL-2020 protocol

CONDITIONS

Official Title

Newly-diagnosed Pediatric Ph-positive B-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 18 years.
  • Newly diagnosed Philadelphia chromosome-positive or BCR::ABL1-positive B-ALL.
  • Written informed consent of the parents or legally authorized guardian according to local laws and regulations.
Not Eligible

You will not qualify if you...

  • ALL evolved from chronic myeloid leukemia.
  • Known underlying congenital immunodeficiency or metabolic disease.
  • Congenital heart disease with cardiac insufficiency.
  • Gastrointestinal dysfunction or diseases that may affect drug absorption.
  • Severe malnutrition, uncontrolled infections, or serious cardiovascular diseases.
  • Significant CNS disorders such as uncontrolled seizures or autoimmune CNS diseases.
  • Treatment with glucocorticoids for 14 days or more, targeted inhibitors for more than 7 days within one month before enrollment, or chemotherapy, systemic anticancer therapy, or radiotherapy within 3 months before enrollment (except emergency radiotherapy).
  • Significant comorbidities or psychiatric disorders impacting safety, compliance, consent, participation, follow-up, or study results interpretation.

AI-Screening

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Trial Site Locations

Total: 24 locations

1

Anhui Medical University Second Affiliated Hospita

Hefei, Anhui, China

Not Yet Recruiting

2

Chongqing Medical University Affiliated Children's Hospital

Chongqing, Chongqing Municipality, 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 First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 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

The Third Xiangya Hospital of the Central South University

Changsha, Hunan, China

Not Yet Recruiting

13

Nanjing Children's Hospital Affiliated to Nanjing Medical University

Nanjin, 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

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Not Yet Recruiting

19

Shanghai Children's Hospital

Shanghai, Shanghai Municipality, China

Not Yet Recruiting

20

Shenzhen Children's Hospital

Shenzhen, Shenzhen, China

Not Yet Recruiting

21

West China Second University Hospita

Chengdu, Sichuan, China

Not Yet Recruiting

22

Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC

Tianjin, Tianjin Municipality, China

Actively Recruiting

23

Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC

Tianjin, Tianjin Municipality, China

Not Yet Recruiting

24

Hong Kong Children's Hospital, The Chinese University of Hong Kong

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

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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