NGS MRD-Guided Blinatumomab Treatment for Pediatric B-ALL

NCT06763302 | Not Yet Recruiting DMC

• 1 other identifier: 2024-IRB-0307-P-01
• Study Type: interventional
• Target: 1,220
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to determine whether pediatric B-cell acute lymphoblastic leukemia (B-ALL) patients with negative deep minimal residue disease (MRD) can benefit from blinatumomab treatment. The main questions it aims to answer are:

1. 1.Whether the application of blinatumomab can improve the long-term survival of next generation sequence (NGS) MRD-positive B-ALL children after consolidation therapy?
2. 2.Whether the application of blinatumomab can benefit the NGS MRD-negative B-ALL children after consolidation therapy?

Conditions

B Cell Precursor Acute Lymphoblastic Leukemia; Pediatric; Minimal Residual Disease; Next Generation Sequencing (NGS)

Outcome Measures

Primary Outcomes (2)

• event free survival

  Death during induction, abandonment before complete remission, death in continuous complete remission, relapse, and secondary Death during induction, abandonment before complete remission (CR), death in continuous complete remission (CCR), relapse, and secondary malignancies were considered as events in the calculation of EFS probability.

  From enrollment to the 3-year after the end of treatment

• Relapse free survival

  RFS was measured by the time from achievement of CR to last follow-up or first relapse and censored at the first event (death, secondary malignancies) except relapse.

  From enrollment to the 3-year after the end of treatment

Secondary Outcomes (1)

• Treatment-Related Adverse Events as Assessed by CTCAE v4.0

  From enrollment to the 3-year after the end of treatment

Study Arms (3)

EOC NGS MRD positive Group

EXPERIMENTAL

Based on the B-ALL treatment protocol, NGS MRD levels will be monitored at the end of consolidation treatment (EOC). If NGS MRD is positive (≥0.0001%), one course of blinatumomab (28 days) will be added after the consolidation treatment.

Drug: Blinatumomab

EOC NGS MRD negative Group A

ACTIVE COMPARATOR

Based on the B-ALL treatment protocol, NGS MRD levels will be monitored at the end of consolidation treatment (EOC). If NGS MRD is negative (\< 0.0001%), the IR/HR patients will be randomized into A and B two groups. EOC NGS MRD negative Group A will be added by one course of blinatumomab (28 days) treatment after the consolidation treatment.

Drug: Blinatumomab

EOC NGS MRD negative Group B

NO INTERVENTION

Based on the B-ALL treatment protocol, NGS MRD levels will be monitored at the end of consolidation treatment (EOC). If NGS MRD is negative (\< 0.0001%), the IR/HR patients will be randomized into A and B two groups. EOC NGS MRD negative Group B will continue the original chemotherapy treatment plan.

Interventions

Blinatumomab DRUG

The FDA has approved blinatumomab for post-consolidation treatment in all Ph-negative B-ALL cases, regardless of MRD status. Considering the high cost of blinatumomab and the financial burden on families, we aim to precisely identify the population who would benefit from blinatumomab and provide appropriate treatment.

EOC NGS MRD negative Group A; EOC NGS MRD positive Group

Eligibility Criteria

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

You may qualify if:

• Clincial dianogsis of acute lymphoblastic leukemia (B-cell type) by morphology, immunology, cytogenetics, and molecular biology (MICM).
• Age ≥1 year and \<18 years.
• Informed consent signed, with the parents or guardians agreeing to a unified treatment protocol.

You may not qualify if:

• Age \<1 year or ≥18 years.
• Immunophenotyping suggests mature B-cell leukemia, mixed-lineage leukemia, or T-cell acute lymphoblastic leukemia.
• Secondary leukemia or second tumor, CML blast phase ALL.
• Other tumors or immunodeficiency diseases present.

Sponsors & Collaborators

• The Children's Hospital of Zhejiang University School of Medicine: lead

Related Publications (1)

• Chen H, Gu M, Liang J, Song H, Zhang J, Xu W, Zhao F, Shen D, Shen H, Liao C, Tang Y, Xu X. Minimal residual disease detection by next-generation sequencing of different immunoglobulin gene rearrangements in pediatric B-ALL. Nat Commun. 2023 Nov 17;14(1):7468. doi: 10.1038/s41467-023-43171-9.

  PMID: 37978187 BACKGROUND

MeSH Terms

Conditions

Neoplasm, Residual

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiaojun Xu

CONTACT

+86-571-88873450; xuxiaojun@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 8, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share