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Clinical Trial NCT06607419 (BBClean) for B-Cell Lymphoblastic Leukemia is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia (BBClean) Phase 2, Phase 3 90 Pediatric

Recruiting
Clinical Trial NCT06607419 (BBClean) is designed to study Treatment for B-Cell Lymphoblastic Leukemia. It is a Phase 2 Phase 3 interventional study that is recruiting, having started on 21 May 2024, with plans to enroll 90 participants. Led by Shanghai Jiao Tong University School of Medicine, it is expected to complete by 31 May 2030. The latest data from ClinicalTrials.gov was last updated on 23 September 2024.
Brief Summary
The goal of this clinical trial is to evaluate the efficacy of Blinatumomab in pediatric patient with newly diagnosed acute B-Lymphoblastic leukemia with poor response to early chemotherapy, i.e. day 19 MRD ≥ 0.1% (low-risk) or day 19 MRD ≥ 0.01% (intermediate-risk). The main question is:

• If the flow cytometric MRD negative (<0.01%) rate and the NGS- MRD negative (<0.0001%) rate at the end of induction for patie...

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Official Title

Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia

Conditions
B-Cell Lymphoblastic Leukemia
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • BBClean
  • CBC-ALL2024-1
NCT ID Number
NCT06607419
Start Date (Actual)
2024-05-21
Last Update Posted
2024-09-23
Completion Date (Estimated)
2030-05-31
Enrollment (Estimated)
90
Study Type
Interventional
PHASE
Phase 2
Phase 3
Status
Recruiting
Keywords
Children
B-Cell Lymphoblastic Leukemia
Blinatumomab
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalBlinatumomab
Patients in this group should receive Blinatumomab
Blinatumomab
Recruited patients will receive Blinatumomab since day 29 of induction for 14 days.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
The flow cytometric MRD
The flow cytometric MRD negative (\<0.01%) rate at the end of induction for patients received Blinatumomab will superior to historical control (D46MRD in the CCCG-ALL2020 protocol)
From the date of Blinatumomab completion to one week after its treatment course
The NGS- MRD
The NGS- MRD negative (\<0.0001%) rate at the end of induction for patients received Blinatumomab will superior to historical control (D46MRD in the CCCG-ALL2020 protocol)
From the date of Blinatumomab completion to one week after its treatment course
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
5-year EFS
The 5-year EFS of study group was significantly higher than that of the control group.
5 years since the last recruited patient completed Blinatumomab.
Adverse events
Comparison of adverse events in study and control groups
From day 19 of induction therapy until the start of the second high-dose methotrexate regimen.
Healthcare costs
Comparison of healthcare costs in study and control groups
Six-month since window phase
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult
Minimum Age
1 Month
Eligible Sexes
All
  • Age older than 1 month to younger than 18 years.
  • Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
  • Immunophenotyping: acute B-lymphoblastic leukemia;
  • Meet one of the following situations:

A. Provisional low-risk: D19MRD ≥ 0.1%; B. Provisional intermediate-risk: D19MRD ≥ 0.01%;

  • Subjects in the sytudy group or their guardians must be able to understand and accept the informed consent approved by the Ethics Committee

  • sIgM+;
  • ALL evolved from chronic myeloid leukemia (CML);
  • Down's syndrome, or major congenital or hereditary disease with organ dysfunction;
  • Other secondary leukemias;
  • CNS involvement;
  • History of epilepsy; or convulsions within the last month;
  • Known underlying congenital immunodeficiency or metabolic disease;
  • Congenital heart disease with cardiac insufficiency;
  • Treated with glucocorticoids 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);
  • Initial diagnosis of high risk;
  • D46MRD ≥1%.
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Study Responsible Party
Shuhong Shen, Principal Investigator, Chair of hematology oncology department of SCMC, Shanghai Jiao Tong University School of Medicine
Study Central Contact
Contact: Shuhong Shen, PhD/MD, 86-18930830638, [email protected]
Contact: Wenting Hu, MD, 13524836748, [email protected]
4 Study Locations in 1 Countries

Anhui

Anhui Provincial Children's Hospital, Hefei, Anhui, 230051, China
Hongjun Liu, MD, Contact, 13515657759, [email protected]
Not yet recruiting

Fujian

Fujian Children's Hospital, Fuzhou, Fujian, 350011, China
Hui Zhang, PhD/MD, Contact, 15821333007, [email protected]
Not yet recruiting

Shanghai Municipality

Shanghai Children's Medical center, Shanghai, Shanghai Municipality, 200127, China
Shuhong Shen, PhD/MD, Contact, 86-21-38626161, [email protected]
Wenting Hu, MD, Contact, 13524836748, [email protected]
Shuhong Shen, PhD/MD, Principal Investigator
Wenting Hu, MD, Sub-Investigator
Changcheng Chen, MD, Sub-Investigator
Recruiting

Zhejiang

Ningbo Women and Children's Hospital, Ningbo, Zhejiang, 315012, China
Binfei Hu, MD, Contact, 13777028360, [email protected]
Recruiting