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

NCT06607419 | Recruiting Phase 2 FDA Drug

• 1 other identifier: CBC-ALL2024-1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 4

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 patients received Blinatumomab will be superior to historical control (D46MRD in the CCCG-ALL2020 protocol). Participants will:
• Take 14 days full dose Blinatumomab;
• With bone marrow evaluated before and after Blinatumomab treatment.

Conditions

B-Cell Lymphoblastic Leukemia

Keywords

Children; B-Cell Lymphoblastic Leukemia; Blinatumomab

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 5-year EFS

  5 years since the last recruited patient completed Blinatumomab.

• Adverse events

  From day 19 of induction therapy until the start of the second high-dose methotrexate regimen.

• Healthcare costs

  Six-month since window phase

Other Outcomes (1)

• Effects of Blinatumomab on immune function

  From the day of or before Blinatumomab to 3-7 days after termination of Blinatumomab.

Study Arms (1)

Blinatumomab

EXPERIMENTAL

Patients in this group should receive Blinatumomab

Drug: Blinatumomab

Interventions

Blinatumomab DRUG

Recruited patients will receive Blinatumomab since day 29 of induction for 14 days.

Blinatumomab

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Fujian Children's Hospital: collaborator
• Zhangzhou Affiliated Hospital of Fujian Medical University: collaborator
• Guizhou Provincial People's Hospital: collaborator
• The First Affiliated Hospital of Xiamen University: collaborator
• Dalian Women and Children's Medical Center: collaborator
• The Third Xiangya Hospital of Central South University: collaborator
• Hunan Provincial People's Hospital: collaborator
• Ningbo Women & Children's Hospital: collaborator
• Anhui Provincial Children's Hospital: collaborator
• Jiangxi Province Children's Hospital: collaborator
• Yuying Children's Hospital of Wenzhou Medical University: collaborator

Study Sites (4)

Anhui Provincial Children's Hospital

Hefei, Anhui, 230051, China

NOT YET RECRUITING

Fujian Children's Hospital

Fuzhou, Fujian, 350011, China

NOT YET RECRUITING

Shanghai Children's Medical center

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Ningbo Women and Children's Hospital

Ningbo, Zhejiang, 315012, China

RECRUITING

Related Publications (20)

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MeSH Terms

Conditions

Burkitt Lymphoma

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Shuhong Shen, PhD/MD

CONTACT

86-18930830638; shenshuhong@scmc.com.cn

Wenting Hu, MD

CONTACT

13524836748; huwenting@scmc.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of hematology oncology department of SCMC

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 23, 2024
• Study Start: May 21, 2024
• Primary Completion: May 31, 2025
• Study Completion (Estimated): May 31, 2030
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)