Monitoring Minimal Residual Disease（MRD）in Pediatric B-acute Lymphoblastic Leukemia

NCT04977895 | Unknown

• 1 other identifier: MRD
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

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

B Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (2)

• The sensitivity of MRD detection by IgH V(D)J NGS and FCM

  The percentage of participants with MRD positive status from baseline to induction treatment completion determined by by IgH V(D)J NGS and FCM

  During Induction Phase: up to 3 months

• Relapse-free survival (RFS)

  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.

  up to 5 years

Secondary Outcomes (3)

• MRD dynamic

  During Induction Phase: up to 3 months

• Overall survival (OS)

  up to 5 years

• Event-free survival (EFS)

  up to 5 years

Interventions

Minimal residual disease (MRD) monitoring DIAGNOSTIC_TEST

Minimal residual disease (MRD) assay using IgH-V(D)J NGS and FCM

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients under age of 18 years with newly diagnosed B-ALL

You may qualify if:

• Age≤18 years.
• Newly diagnosed B-ALL.
• No previous treatment.
• Signed informed consent in keeping with the policies of the hospital.

You may not qualify if:

• History of other malignancies, except in situ carcinoma or malignancy treated with curative intent.
• Patients with active or uncontrollable infections such as hepatitis B, hepatitis C or HIV infection.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bone marrow

MeSH Terms

Conditions

Burkitt Lymphoma

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

Study Officials

• Yi-Zhuo Zhang, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Zhuo Zhang, MD

CONTACT

18622221239; zhangyzh@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 11, 2021
• First Posted: July 27, 2021
• Study Start: January 30, 2021
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2026
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

CN (1)