Clinical trial · Observational
Monitoring Minimal Residual Disease（MRD）in Pediatric B-acute Lymphoblastic Leukemia
A Study to Assess Minimal Residual Disease by Next-generation Sequencing of Immunoglobulin Gene Rearrangements in Pediatric B-acute Lymphoblastic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aimed to investigate the performance of next-generation sequencing (NGS) techniques measuring immunoglobulin heavy chain (IgH)-variable, diversity, and joining (V\[D\]J) clonal rearrangements （IgH-V\[D\]J NGS） compared with flow cytometry (FCM) in detecting of minimal residual disease (MRD) for children with acute lymphoblastic leukemia treated with South Chinese Children Leukemia Group (SCCLG)-ALL 2016, and to predict the relapse of the disease in the early stage and to assess the prognosis, so as to provide the basis for early intervention treatment and reduce the hematological relapse and improve the survival rate.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Minimal residual disease (MRD) monitoring | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- The sensitivity of MRD detection by IgH V(D)J NGS and FCM
- timeFrame
- During Induction Phase: up to 3 months
- description
- The percentage of participants with MRD positive status from baseline to induction treatment completion determined by by IgH V(D)J NGS and FCM
- measure
- Relapse-free survival (RFS)
- timeFrame
- up to 5 years
- description
- RFS was estimated from the date of diagnosis until the date of relapse at any site. For other participants, last follow-up available was taken as last control. If participant did not complete study, date of last visit available was considered.
Secondary outcomes (3)
- measure
- MRD dynamic
- timeFrame
- During Induction Phase: up to 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age≤18 years. 2. Newly diagnosed B-ALL. 3. No previous treatment. 4. Signed informed consent in keeping with the policies of the hospital. Exclusion Criteria: 1. History of other malignancies, except in situ carcinoma or malignancy treated with curative intent. 2. Patients with active or uncontrollable infections such as hepatitis B, hepatitis C or HIV infection. 3. Patients with uncontrolled autoimmune diseases or immune defects. Other protocol-defined Inclusion/Exclusion may apply.
References
Publications (0)
Data not yet available