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

Last updated: February 4, 2025
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Overall Status: Active - Recruiting

Phase

2/3

Condition

Leukemia

Treatment

Venetoclax (nonRand Group)

Blinatumomab (Group B)

Blinatumomab (Group A)

Clinical Study ID

NCT06764238
IIT2024068
  • Ages 1-18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age older than 1 month to younger than 18 years.

  2. Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.

  3. Diagnosis of B-ALL by immunophenotyping.

Exclusion

Exclusion Criteria:

  1. Low-risk ALL

  2. sIgM+

  3. Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.

  4. ALL evolved from chronic myeloid leukemia (CML).

  5. Down's syndrome, or major congenital or hereditary disease with organ dysfunction

  6. Secondary leukemia

  7. Known underlying congenital immunodeficiency or metabolic disease

  8. Congenital heart disease with cardiac insufficiency.

  9. Treated with glucocorticoids for ≥14 days, or ABL kinase inhibitors for > 7 dayswithin one month before enrollment, or any chemotherapy or radiotherapy within 3months before enrollment (except for emergency radiotherapy to relieve airwaycompression)

Study Design

Total Participants: 1800
Treatment Group(s): 3
Primary Treatment: Venetoclax (nonRand Group)
Phase: 2/3
Study Start date:
January 03, 2025
Estimated Completion Date:
June 30, 2031

Study Description

The study shown above will lead to the following revisions to the CCCG-ALL2025 I/HR-B-ALL plan, which will be based on the CCCG-ALL2020 plan.

  1. After the induction remission phase, all I/HR-B-ALL patients can afford blinatumomab will participate in a blinatumomab+HDMTX randomized controlled trial as consolidation.

  2. For patients cannot afford blinatumomab will be treated with venetoclax + modified mini-hyperCVD during the induction phase, then subsequently with CAT as consolidation phase. CAT will removed from induction phase.

  3. For patients who received blinatumomab randomization, the CAT+ course was canceled.

  4. All patients will continued with 6 cycles of alternated 5-day venetoclax or Dauno-based CCCG-2020 continuous therapy regimen.

  5. Adding IgH rearrangement NGS MRD as an evaluation indicator.

  6. Adding pharmacotyping study for I/HR B-ALL.

  7. Three more bone marrow punctures and IT will be added with the aims to evaluate the CR rate with deepen remission during or after consolidation.

Connect with a study center

  • Anhui Medical University Second Affiliated Hospital

    Hefei, Anhui
    China

    Site Not Available

  • Anhui Provincial Children's Hospital

    Hefei, Anhui
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian
    China

    Site Not Available

  • Guangzhou Women and Children's Medical Center

    Guangzhou, Guangdong
    China

    Site Not Available

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong
    China

    Site Not Available

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi
    China

    Site Not Available

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou
    China

    Site Not Available

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

    Wuhan, Hubei
    China

    Site Not Available

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

    Wuhan, Hubei
    China

    Site Not Available

  • Wuhan Children's Hospital

    Wuhan, Hubei
    China

    Site Not Available

  • Hunan Children's Hospital

    Changsha, Hunan
    China

    Site Not Available

  • Xiangya Hospital Central South University

    Changsha, Hunan
    China

    Site Not Available

  • Nanjing Children's Hospital Affiliated to Nanjing Medical University

    Nanjing, Jiangsu
    China

    Site Not Available

  • Children's Hospital of Soochow University

    Suzhou, Jiangsu
    China

    Site Not Available

  • Jiangxi Provincial Children's Hospital

    Nanchang, Jiangxi
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, Shandong
    China

    Site Not Available

  • Affiliated Hospital of Qingdao University

    Qingdao, Shandong
    China

    Site Not Available

  • Xi'an Northwest Women and Children Hospital

    Xi'an, Shanxi
    China

    Site Not Available

  • West China Second University Hospital, Sichuan University

    Chengdu, Sichuan
    China

    Site Not Available

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

    Tianjin, Tianjin 300020
    China

    Active - Recruiting

  • Chongqing Medical University Affiliated Children's Hospital

    Chongqing,
    China

    Site Not Available

  • Children's Hospital of Fudan University

    Shanghai,
    China

    Site Not Available

  • Shanghai Children's Hospital

    Shanghai,
    China

    Site Not Available

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

    Shanghai,
    China

    Site Not Available

  • Shenzhen Children's Hospital

    Shenzhen,
    China

    Site Not Available

  • Hong Kong Children's Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

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