Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2020-07-01
2026-06-30
Brief Summary
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Detailed Description
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The second part of the study aimed to develop novel antibody for treatment of childhood leukemia by animal model experiments.
Design:
Project 1: Whole-exome and RNA sequencing will be performed on children with leukemia (ALL, AML, MPAL, JMML, MDS) prospectively recruited in the Hong Kong Children's Hospital. Samples will be screened for their sensitivity to preselected, clinically accessible targeted agents in an ex vivo culture system. Results for the high-risk patients will be subjected to the tumor broad for evaluation.
Project 2: Fully human antibody candidates identified by phage display will be engineered into therapeutic forms, and assessed for efficacy and safety in patient-derived xenografts of relapsed/refractory B-ALL and in transgenic mice. The mechanisms of action will be identified by single-cell RNA sequencing.
Significance:
Implementation of functional genomics could identify leukemia patients who will benefit from targeted therapies and enable tailoring of precision medicine. The invented antibodies could be moved forward into clinical trials for salvaging high-risk pediatric B-ALL. Immediate and long-term impact on therapy of childhood leukemia is foreseen.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Childhood Leukemia
Peripheral blood and bone marrow samples are collected for genetic analysis, invitro drug sensitivity test and animal experiment.
RNA-seq
Gene expression and fusion transcripts analysis
whole exon sequencing
Genetic alternation analysis
Cytogenetics test
Remission and relapse are monitored by cytogenetic analyses.
Interventions
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RNA-seq
Gene expression and fusion transcripts analysis
whole exon sequencing
Genetic alternation analysis
Cytogenetics test
Remission and relapse are monitored by cytogenetic analyses.
Eligibility Criteria
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Inclusion Criteria
2. acute myeloid leukemia (AML) or
3 .mixed phenotype acute leukemia (MPAL) or
4\. juvenile myelomonocytic leukemia (JMML) or
5\. myelodysplastic syndromes (MDS) or
6\. normal bone marrow donor
Exclusion Criteria
2. Patient or parent refusal
18 Years
ALL
Yes
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Kathy Chan
Scientific Officer
Principal Investigators
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Kam Tong Leung, Ph. D.
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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Hong Kong Children Hospital
Hong Kong, Hksar, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HKCH-REC-2020-012
Identifier Type: -
Identifier Source: org_study_id
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