Clinical trial NCT06882057: Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol
Official title: Chinese Children's Cancer Group-2025 Protocol for Newly Diagnosed Low Risk Childhood B-cell Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Acute Lymphoblastic Leukemia ALL
Childhood Leukemia, Acute Lymphoblastic
B Cell Acute Lymphoblastic Leukemia (B-ALL)
Keywords: blinatumomab
chemo-light
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 3000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 1. All LR-B-ALL patients will be treated with 14 days of blinatumomab (Blina-14) as early intensification to replace CAT+ (historically given in LR-B-AL with MRD19\>0.1% in the 2020 protocol).
2. Two courses of HD-MTX will be administered as consolidation phase, maintaining the same dose of 3 g/m².
3. Second 14 days of blinatumomab will be given after completion of HDMTX consolidation treatment .
4. Adding IgH rearrangement NGS MRD as an evaluation indicator. Reinduction-2 will be omitted for patients with NGS-MRD46\<10-6 who have receive the second course of Blina-14. (Reinduction-2 should be given regardless of NGS-MRD 46 status in patients who did not receive the second course of binatumomab).
5. A total of four repeating courses will be applied in Maintenance 1 (in contrast to 5 courses in 2020 protocol). Additionally, one-week rest period will be implemented after each course to ensure safety and optimal efficacy.
6. Patients with FCM-MRD19\<0.01% and IgH rearrangement NGS MRD 46\<10-6 will receive chemo-light maintenance-2 with 4 cyles of 8-week course of MTX + 6MP (totally 32 weeks). The other patients with higher levels of MRD by FCM MRD or NGS MRD will receive maintenance-2 with 9 cycles of 8-week course of MTX + 6MP for a total of 72 weeks (same as CCCG-ALL2020)
7. Bone Marrow Aspiration Assessment (BMA): One additional bone marrow puncture at the end of 1st Blina-14 course (Day60 MRD) will be performed at early intensification phase. This results in a total of 4 BMAs in the CCCG2025-LR protocol, in contrast to 3 BMAs in 2020 protocol.
8. Triple Intrathecal Therapy (TIT)：In the HDMTX consolidation phase, there will be two TITs in contrast to four treatments in the CCCG2020 protocol. To compensate for this reduction, two additional TIT treatments will be administrated before the 1st and 2nd Blina-14 courses. Additionally, two intrathecal treatments will be added during Reinduction 1 and Reinduction 2 to further enhance CNS control. Meanwhile, one TIT will be reduced in the Maintenance-1 phase compared to 2020 protocol. This results in a total of 16 or 17 TITs, depending on whether the second Blina-14 course is applied This is similar to the CCCG2020, where 16 or 17 TITs are administrated depending on whether CAT+ was given).
9. Adding pharmacotyping study for LR B-ALL.
10. Treatment duration: The treatment duration for the CCCG-LR-ALL-2020 protocol is 121/124 weeks (depending on if CAT+ was given). In the CCCG-LR-ALL-2025 protocol:

    * For patients with NGS MRD46 ≥10-6, the total treatment duration is 123 weeks. Key changes include: 2 weeks of Blina-14 replacing 3 weeks of CAT+, 2 courses of HDMTX reduction (4 weeks), and an additional 2 weeks for the 2nd blina-14 course added following HDMTX;
    * For patients with MRD19≥ 0.01% and NGS MRD46 \< 10-6 who subsequently receive 2nd Blina-14, Reinduction-2 is omitted, shortening the total duration by 3 weeks. (120 weeks in total). If the 2nd Blina-14 is not administrated, Reinduction -2 will still be included, resulting in a total duration of 121 weeks.
    * For patients with MRD19 \< 0.01% and NGS MRD46 \< 10-6, who subsequently receive 2nd Blina-14, both the Reinduction-2 (3 weeks) and the subsequent 5 cycles of Maintenance-2 (40 weeks) are omitted. This results in a total treatment duration of 80 weeks (81 weeks if 2nd Blina-14 is not applied).

Eligibility criteria: Inclusion Criteria:

Must meet all items below:

1. Age older than 1 year and younger than 18 years.
2. Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
3. Diagnosis of B-ALL by immunophenotyping.
4. Low risk group

Exclusion Criteria:

Should be excluded in the presence of any item below:

1. T-ALL
2. I/HR B-ALL group
3. sIgM+
4. Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.
5. Philadelphia chromosome positive ALL (Ph-ALL)
6. ALL evolved from chronic myeloid leukemia (CML).
7. Down's syndrome, or major congenital or hereditary disease with organ dysfunction
8. Secondary leukemia
9. Known underlying congenital immunodeficiency or metabolic disease
10. Congenital heart disease with cardiac insufficiency.
11. 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)

Primary outcomes:
measure: Compare 3-year event-free survival (EFS) between patients who receive Blina-14 intensification with this historical controls from CCCG-ALL2015 and CCCG-ALL2000
timeFrame: The expected study duration is approximately 5 years.
Secondary outcomes:
measure: Estimate event-free survival (EFS) in patients with deep remission (FCM MRD19<0.01% and Ig-NGS MRD46<10-6) who received Maintenance-2' with reduced intensity chemotherapy
timeFrame: Approximately 6.5 years.
measure: Estimate overall survival (OS) in patients with deep remission (FCM MRD19<0.01% and Ig-NGS MRD46<10-6) who received Maintenance-2' with reduced intensity chemotherapy
timeFrame: Approximately 6.5 years.
measure: Estimate cumulative incidence of relapse (CIR) in patients with deep remission (FCM MRD19<0.01% and Ig-NGS MRD46<10-6) who received Maintenance-2' with reduced intensity chemotherapy
timeFrame: Approximately 6.5 years.
measure: Compare event-free survival (EFS) to those of historical cohorts (CCCG-ALL-2015 and CCCG-ALL2020)
timeFrame: Approximately 6.5 years.
measure: Compare overall survival (OS) to those of historical cohorts (CCCG-ALL-2015 and CCCG-ALL2020)
timeFrame: Approximately 6.5 years.
measure: Compare cumulative incidence of relapse (CIR) to those of historical cohorts (CCCG-ALL-2015 and CCCG-ALL2020)
timeFrame: Approximately 6.5 years.
measure: Compare event-free survival (EFS) between patients with deepen remission (FCM MRD19<0.01% and Ig-NGS MRD46<10-6) who receive one course of Blina-14 and those who recevive two courses of Blina-14.
timeFrame: Approximately 6.5 years
measure: Compare overall survival (OS) between patients with deepen remission (FCM MRD19<0.01% and Ig-NGS MRD46<10-6) who receive one course of Blina-14 and those who recevive two courses of Blina-14.
timeFrame: Approximately 6.5 years
measure: Compare cumulative incidence of relapse (CIR) between patients with deepen remission (FCM MRD19<0.01% and Ig-NGS MRD46<10-6) who receive one course of Blina-14 and those who recevive two courses of Blina-14.
timeFrame: Approximately 6.5 years
Other outcomes:
measure: Compare the 3-year EFS between patients who received Blina-14 intensification with those who received CAT+ intensification
timeFrame: Approximately 3.5 years
measure: Evaluate the significance of the early deep remission rate after Blina-14 intensification by its association with treatment outcomes, especially cumulative incidence of relapse (CIR)
timeFrame: Approximately 6.5 years.
measure: Evaluate toxicities during the immuno-chemo combined therapy in provisional LR-ALL.
timeFrame: Up to 30 days after last dose of study treatment
Locations:
city: Hefei,
country: China
facility: Anhui Provincial Children's Hospital
state: Anhui
city: Hefei
country: China
facility: Anhui Medical University Second Affiliated Hospital
state: Anhui
city: Chongqing
country: China
facility: Chongqing Medical University Affiliated Children's Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Wuhan Children's Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Children's Hospital
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Nanjing
country: China
facility: Nanjing Children's Hospital Affiliated to Nanjing Medical University
state: Jiangsu
city: Soochow
country: China
facility: Children's Hospital of Soochow University
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial Children's Hospital
state: Jiangxi
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Qingdao
country: China
facility: Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Children's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Children's Medical Cener, Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Xi'an
country: China
facility: Xi'an Northwest Women and Children Hospital
state: Shanxi
city: Shenzhen
country: China
facility: Shenzhen Children's Hospita
state: Shenzhen
city: Chengdu
country: China
facility: West China Second University Hospital
state: Sichuan
city: Tianjin
country: China
facility: Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
state: Tianjin
city: Hong Kong
country: Hong Kong
facility: Hong Kong Children's Hospital
Study officials:
affiliation: Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
name: Xiaofan Zhu, MD
role: PRINCIPAL_INVESTIGATOR
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