Monitoring minimal residual disease in children with 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
Sun Yat-sen University · NCT04977895
This study tests if a new DNA testing method can better track leftover cancer cells in children with B-acute lymphoblastic leukemia to help predict relapses and improve treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 255 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04977895 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effectiveness of next-generation sequencing (NGS) techniques in measuring minimal residual disease (MRD) in pediatric patients with B-acute lymphoblastic leukemia (B-ALL). It compares the sensitivity and specificity of IgH-V(D)J NGS against traditional flow cytometry in detecting MRD during treatment. The study aims to predict disease relapse and assess prognosis by monitoring MRD at multiple time points during therapy. By identifying trackable clones in diagnostic samples, the study seeks to improve early intervention strategies and enhance survival rates.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 18 years old who have been newly diagnosed with B-acute lymphoblastic leukemia and have not received prior treatment.
Not a fit: Patients with a history of other malignancies, active infections, or uncontrolled autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate monitoring of MRD, improving treatment outcomes and survival rates for children with B-ALL.
How similar studies have performed: Other studies have shown success with similar NGS approaches for MRD detection, indicating a promising avenue for improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Principal investigator: Yi-Zhuo Zhang, MD — Sun Yat-sen University
- Study coordinator: Yi-Zhuo Zhang, MD
- Email: zhangyzh@sysucc.org.cn
- Phone: 18622221239
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: B Acute Lymphoblastic Leukemia