Detecting measurable residual disease beyond 10-4 by an IGHV leader-based NGS approach improves prognostic stratification in CLL.
Paul J Hengeveld, Michèle Y van der Klift, P Martijn Kolijn...
https://pubmed.ncbi.nlm.nih.gov/36084320/Actively Recruiting
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-26
3000
Participants Needed
27
Research Sites
178 weeks
Total Duration
Researchers are evaluating a new treatment plan called CCCG-ALL2025 for children with newly diagnosed low-risk B-cell acute lymphoblastic leukemia ALL. This plan builds on previous protocols and uses blinatumomab Blina-14 as an early intensification treatment after initial therapy, regardless of the patients measurable residual disease MRD status. The study aims to compare the effectiveness of chemotherapy combined with Blina-14 to previous treatments, with adjustments to maintenance therapy based on deep remission measured by next-generation sequencing Ig-NGS MRD.
CONDITIONS
Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol
X
Xiaofan Zhu, MD
J
Jingliao Zhang, MD
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Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants receive 14 days of blinatumomab as early intensification treatment to replace previous therapy.
1 visit at start and bone marrow aspiration at Day 60
Duration - Approximately 4 weeks
Participants receive two courses of high-dose methotrexate (HD-MTX) as consolidation therapy, including two triple intrathecal therapy treatments.
Multiple visits during consolidation including 2 intrathecal treatments
Duration - 14 days
Participants receive a second 14-day course of blinatumomab after completion of HD-MTX consolidation.
1 visit for infusion
Duration - Varies by participant MRD status, ranging from 32 to 72 weeks
Participants undergo reinduction and maintenance therapy phases, which differ by participant MRD status, including possible omission of Reinduction-2 and adjusted maintenance duration and intensity.
Repeated visits for chemotherapy cycles and intrathecal treatments depending on assigned maintenance regimen
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
3
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Lead Sponsor