Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol (CCCG-LR-B-ALL)

August 23, 2025 updated by: Institute of Hematology & Blood Diseases Hospital, China

Chinese Children's Cancer Group-2025 Protocol for Newly Diagnosed Low Risk Childhood B-cell Acute Lymphoblastic Leukemia

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

3000

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Not yet recruiting
        • Anhui Provincial Children's Hospital
        • Contact:
      • Hefei, Anhui, China
        • Not yet recruiting
        • Anhui Medical University Second Affiliated Hospital
        • Contact:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Not yet recruiting
        • Chongqing Medical University Affiliated Children's Hospital
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China
        • Not yet recruiting
        • Fujian Medical University Union Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Guangzhou Women and Children's Medical Center
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China
        • Not yet recruiting
        • The People's Hospital of Guangxi Zhuang Autonomous Region
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China
        • Not yet recruiting
        • The Affiliated Hospital of Guizhou Medical University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China
        • Not yet recruiting
        • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
      • Wuhan, Hubei, China
        • Not yet recruiting
        • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
      • Wuhan, Hubei, China
        • Not yet recruiting
        • Wuhan Children's Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China
        • Not yet recruiting
        • Xiangya Hospital Central South University
        • Contact:
      • Changsha, Hunan, China
        • Not yet recruiting
        • Hunan Children's Hospital
        • Contact:
      • Changsha, Hunan, China
        • Not yet recruiting
        • The Third Xiangya Hospital of the Central South University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Not yet recruiting
        • Nanjing Children's Hospital Affiliated to Nanjing Medical University
        • Contact:
          • Yongjun Fang, MD
          • Phone Number: 025-83117500
          • Email: fyj322@189.cn
      • Suzhou, Jiangsu, China
        • Not yet recruiting
        • Children's Hospital of Soochow University
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Not yet recruiting
        • Jiangxi Provincial Children's Hospital
        • Contact:
    • Shandong
      • Jinan, Shandong, China
        • Not yet recruiting
        • Qilu Hospital of Shandong University
        • Contact:
      • Qingdao, Shandong, China
        • Not yet recruiting
        • Affiliated Hospital of Qingdao University
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Not yet recruiting
        • Children's Hospital of Fudan University
        • Contact:
      • Shanghai, Shanghai Municipality, China
        • Not yet recruiting
        • Shanghai Children's Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China
        • Not yet recruiting
        • Shanghai Children's Medical Cener, Shanghai Jiao Tong University School of Medicine
        • Contact:
    • Shanxi
      • Xi’an, Shanxi, China
        • Not yet recruiting
        • Xi'an Northwest Women and Children Hospital
        • Contact:
    • Shenzhen
      • Shenzhen, Shenzhen, China
        • Not yet recruiting
        • Shenzhen Children's Hospita
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • West China Second University Hospital
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Recruiting
        • Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
        • Contact:
  • Hong Kong
    • Hong Kong
      • Hong Kong, Hong Kong, Hong Kong
        • Not yet recruiting
        • Hong Kong Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NGS MRD46 ≥ 10^-6
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). Additionally, second 14 days of blinatumomab will be given after completion of HDMTX consolidation treatment. Reinduction-2 and Maintenance-2 will be given in full doses
Drug: Blinatumomab
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). Additionally, second 14 days of blinatumomab will be given after completion of HDMTX consolidation treatment.
Other Names:
  • Dexamethasone
  • Cytarabine
  • 6-MP
  • Methotrexate
  • Prednisone
  • Vincristine
  • Daunorubicin
  • Asparaginase
  • Cyclophosphomide
Experimental: MRD19≥ 0.01% and NGS MRD46 < 10^-6
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). Additionally, second 14 days of blinatumomab will be given after completion of HDMTX consolidation treatment. Reinduction-2 will be omitted, but Maintenance-2 will be given in full doses
Drug: Blinatumomab
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). Additionally, second 14 days of blinatumomab will be given after completion of HDMTX consolidation treatment.
Other Names:
  • Dexamethasone
  • Cytarabine
  • 6-MP
  • Methotrexate
  • Prednisone
  • Vincristine
  • Daunorubicin
  • Asparaginase
  • Cyclophosphomide
Drug: Reinduction-2 omission
Reinduction-2 will be omitted for patients with NGS-MRD46<10^-6 who have receive the two courses of Blina-14.
Other Names:
  • Dexamethasone
  • Cytarabine
  • 6-MP
  • Methotrexate
  • Prednisone
  • Vincristine
  • Daunorubicin
  • Asparaginase
  • Cyclophosphomide
Experimental: MRD19 < 0.01% and NGS MRD46 < 10^-6
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). Additionally, second 14 days of blinatumomab will be given after completion of HDMTX consolidation treatment. Reinduction-2 will be omitted, and 5 cycles of Maintenance-2 will be omitted
Drug: Blinatumomab
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). Additionally, second 14 days of blinatumomab will be given after completion of HDMTX consolidation treatment.
Other Names:
  • Dexamethasone
  • Cytarabine
  • 6-MP
  • Methotrexate
  • Prednisone
  • Vincristine
  • Daunorubicin
  • Asparaginase
  • Cyclophosphomide
Drug: Reinduction-2 omission
Reinduction-2 will be omitted for patients with NGS-MRD46<10^-6 who have receive the two courses of Blina-14.
Other Names:
  • Dexamethasone
  • Cytarabine
  • 6-MP
  • Methotrexate
  • Prednisone
  • Vincristine
  • Daunorubicin
  • Asparaginase
  • Cyclophosphomide
Drug: Chemo-light Maintenance 2
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).
Other Names:
  • Dexamethasone
  • Cytarabine
  • 6-MP
  • Methotrexate
  • Prednisone
  • Vincristine
  • Daunorubicin
  • Asparaginase
  • Cyclophosphomide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare 3-year event-free survival (EFS) between patients who receive Blina-14 intensification with this historical controls from CCCG-ALL2015 and CCCG-ALL2000
Time Frame: The expected study duration is approximately 5 years.

The primary historical control cohort consists of the patients on the CCCG-ALL2020 trial determined as LR after remission indiction, received 2xHDMTX during consolidation and did not receive Bliniatumomab. As of end of 2024, this cohort contains 1111 patients, with 3-year EFS 0.963 and standard error 0.0087, 95% confidence interval [0.953,0.980] . The sample size and power assessment below is based on these data.

The primary comparison is between the patients on this trial who are determined as LR after remission induction to the historical cohort described above, on 3-year EFS probability.

.Power of the above test procedure is assessed by a simulation study. Historical control is set from the preliminary data as S0=0.963,v0^2=0.0087^2. For the current trial total sample size is set to n=2325 with 5 year accrual.LN distribution is chosen for its good assemblance of the EFS functions of the LR cohorts in the historical data.
The expected study duration is approximately 5 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Approximately 6.5 years.
The EFS functions will be estimated by the Kaplan-Meier method along with 95% confidence intervals at specified timepoints (e.g., 1, 3, 5 years since diagnosis).
Approximately 6.5 years.
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
Time Frame: Approximately 6.5 years.
The OS functions will be estimated by the Kaplan-Meier method along with 95% confidence intervals at specified timepoints (e.g., 1, 3, 5 years since diagnosis).
Approximately 6.5 years.
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
Time Frame: Approximately 6.5 years.
The CIR curve will be estimated by Kalbafleisch-Prentice method, along with 95% confidence intervals.
Approximately 6.5 years.
Compare event-free survival (EFS) to those of historical cohorts (CCCG-ALL-2015 and CCCG-ALL2020)
Time Frame: Approximately 6.5 years.
The EFS functions will be estimated by the Kaplan-Meier method along with 95% confidence intervals at specified timepoints (e.g., 1, 3, 5 years since diagnosis). Standard error will be estimated using the default procedure in R. Follow up of the historical comparison cohort (CCCG-ALL-2020 and 2015) will continue during the course of the current trial. Comparisons of EFS will be performed using two-sided log-rank test. Multivariable regression modeling including trial (CCCGALL-2025 vs. 2020 or 2015) and other known prognostic factors as main effects may also be performed, using the Cox models.
Approximately 6.5 years.
Compare overall survival (OS) to those of historical cohorts (CCCG-ALL-2015 and CCCG-ALL2020)
Time Frame: Approximately 6.5 years.
The OS functions will be estimated by the Kaplan-Meier method along with 95% confidence intervals at specified timepoints (e.g., 1, 3, 5 years since diagnosis). Comparison of OS functions will be conducted using the two-sided log-rank test. Standard error will be estimated using the default procedure in R. Follow up of the historical comparison cohort (CCCG-ALL-2020 and 2015) will continue during the course of the current trial. Comparisons of OS will be performed using two-sided log-rank test. Multivariable regression modeling including trial (CCCGALL-2025 vs. 2020 or 2015) and other known prognostic factors as main effects may also be performed, using the Cox models.
Approximately 6.5 years.
Compare cumulative incidence of relapse (CIR) to those of historical cohorts (CCCG-ALL-2015 and CCCG-ALL2020)
Time Frame: Approximately 6.5 years.
CIR functions of relapse will be estimated by the Kalbafleisch-Prentice method. Follow up of the historical comparison cohort (CCCG-ALL-2020 and 2015) will continue during the course of the current trial. Comparisons of CIR will be performed by Gray's test. Multivariable regression modeling including trial (CCCGALL-2025 vs. 2020 or 2015) and other known prognostic factors as main effects may also be performed, using the Fine-Gray models.
Approximately 6.5 years.
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.
Time Frame: Approximately 6.5 years
The EFS functions will be estimated by the Kaplan-Meier method along with 95% confidence intervals at specified timepoints (e.g., 1, 3, 5 years since diagnosis). Standard error will be estimated using the default procedure in R. Comparisons of EFS will be performed using two-sided log-rank test. Multivariable regression modeling including known prognostic factors as main effects may also be performed, using the Cox models.
Approximately 6.5 years
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.
Time Frame: Approximately 6.5 years
The OS functions will be estimated by the Kaplan-Meier method along with 95% confidence intervals at specified timepoints (e.g., 1, 3, 5 years since diagnosis). Standard error will be estimated using the default procedure in R. Comparisons of OS will be performed using two-sided log-rank test. Multivariable regression modeling including known prognostic factors as main effects may also be performed, using the Cox models.
Approximately 6.5 years
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.
Time Frame: Approximately 6.5 years
CIR functions of relapse will be estimated by the Kalbafleisch-Prentice method. Comparisons of CIR will be performed by Gray's test. Multivariable regression modeling including known prognostic factors as main effects may also be performed, using the Fine-Gray models.
Approximately 6.5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the 3-year EFS between patients who received Blina-14 intensification with those who received CAT+ intensification
Time Frame: Approximately 3.5 years
The EFS functions will be estimated by the Kaplan-Meier method along with 95% confidence intervals at 3 years since diagnosis. Standard error will be estimated using the default procedure in R. Comparison will be made using the Z-test procedure described in primary endpoint.
Approximately 3.5 years
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)
Time Frame: Approximately 6.5 years.
CIR functions of relapse will be estimated by the Kalbafleisch-Prentice method. Associations between deep remission status after blinatumimab treatment and relapse will be analysed using Gray's test or Fine-Gray regression models, as appropriate.
Approximately 6.5 years.
Evaluate toxicities during the immuno-chemo combined therapy in provisional LR-ALL.
Time Frame: Up to 30 days after last dose of study treatment
Proportions of grade-3 or higher AEs in each treatment phase will be estimated by the sample proportions along with exact 95% confidence intervals. Cumulative incidences of various grade-3 or higher AEs throughout therapy will be estimated by the Kalbafleisch-Prentice method; death, relapse and other events rendering off therapy before completion are regarded as competing risks
Up to 30 days after last dose of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Investigators

  • Principal Investigator: Xiaofan Zhu, MD, Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2025

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

June 1, 2033

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 18, 2025

Study Record Updates

Last Update Posted (Estimated)

August 26, 2025

Last Update Submitted That Met QC Criteria

August 23, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2025021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

  1. Demographic Data: Age, sex, and other relevant baseline characteristics.
  2. Treatment Information: Data on interventions received by participants, including dosage, treatment cycles, and duration.
  3. Outcome Measures: Detailed information on primary and secondary outcome measures, such as response rates, survival rates, adverse events, and any the pre-specified endpoints.
  4. Adverse Events: Data on all reported adverse events, including severity, duration, and outcome.
  5. Laboratory Data: Results from laboratory tests, such as blood counts, biochemical markers, or molecular analysis.
  6. Medical History: Pre-existing conditions, comorbidities, and prior treatments or interventions.
  7. Vital Signs: relevant physiological data.
  8. Efficacy and Safety Data: Any data relating to the efficacy (e.g., event-free survival) and safety (e.g., adverse effects) of the treatment.

IPD Sharing Time Frame

IPD will be made available upon publication of the primary trial results or after trial completion, whichever occurs first, starting on 2032, and will remain accessible for 5 years.

IPD Sharing Access Criteria

Researchers, healthcare professionals who meet the criteria for access (e.g., academic researchers conducting secondary analyses or regulatory bodies reviewing safety data) will be able to request access to de-identified IPD and supporting information. Access will be facilitated through clinical trials.gov/emailing to PI, where users can submit a request and provide a research proposal. Data access will be granted after a formal review and approval process, subject to compliance with the data-sharing agreement and confidentiality terms.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: CCCG-ALL
    Information comments: CCCG-ALL-2025 DATASET

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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