Advanced Translational Research on Childhood Leukemia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorChinese University of Hong Kong

About this trial

Prognosis of children with leukemia, the most common pediatric cancer, has improved markedly. Yet, relapse still occurs in 15-40% of patients with a probability of survival of \<50%, which is unlikely to be boosted by intensification of standard chemotherapy due to overwhelming toxicity. The advent of effective and safe targeted therapies for high-risk cases is therefore imperative. This study constitutes two research projects aiming at driving therapeutic advances.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

acute lymphoblastic leukemia (ALL) or

acute myeloid leukemia (AML) or

Disqualifiers

This study will not recruit subjects who are unable to understand English or Chinese.

Patient or parent refusal

Trial population

Children suspected or diagnosed with leukemia at presentation will be recruited for the study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • RNA-seq

    Genetic

    Gene expression and fusion transcripts analysis

  • whole exon sequencing

    Genetic

    Genetic alternation analysis

  • Cytogenetics test

    Other intervention

    Remission and relapse are monitored by cytogenetic analyses.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Childhood Leukemia3 interventions

Trial outcomes

Primary outcomes

1

Genetic alterations of childhood leukemia

Association of mutation data with drug sensitivity profiles and disease-free survival /overall survival are analysed using standard statistical methods.

Time frame
Baseline
2

Gene expression profiles of childhood leukemia

Global transcriptome and fusion transcripts of leukemic blasts are identified by RNA-sequencing.

Time frame
Baseline
3

Drug sensitivity profiles

Drug sensitivity results of individual patient blasts-derived ex vivo culture are presented as IC50 and AUC values.

Time frame
Baseline
4

Antibody efficacy for treatment of childhood leukemia

In vitro biochemical and biological assays and invivo leukemic patient-derived xenografts are used to characterize the efficacy and toxicity of the novel human anitbodies.

Time frame
Up to 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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