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Using Mobile Technology-assisted Outpatient Maintenance Therapy Pediatric ALL

A Randomized Controlled Trial of Mobile Technology-assisted Outpatient Maintenance Therapy in Children With Acute Lymphoblastic Leukaemia (ALL)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07278882
Enrollment
100
Registered
2025-12-12
Start date
2025-12-01
Completion date
2027-11-20
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Acute Leukemia

Brief summary

To assess the efficacy of using mobile technology to improve the percentage of time wherein drug dosing is within the target range

Interventions

BEHAVIORALHealth monitoring & reminders for a mobile-phone portal for scheduling a telemedicine clinic visit and receive periodic model-phone messages instructing follow-up blood testing and dose adjustment.

Subjects classified as 'Orange Alert' receive mobile-phone alert messages that instruct them to self-adjust dose of oral medication. Subjects classified as 'Red Alert' are directed to a mobile-phone portal for scheduling a telemedicine clinic visit and receive periodic model-phone messages instructing follow-up blood testing and dose adjustment.

Sponsors

Institute of Hematology & Blood Diseases Hospital, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No

Inclusion criteria

1. \< 16 years old at diagnosis; 2. having demonstrated ≥ 3 months of \> 90% compliance with using a mobile app to log in records of daily medication and weekly blood test results; 3. no further in-hospital chemotherapy; 4. patient or legal guardian provides informed consent.

Exclusion criteria

None

Design outcomes

Primary

MeasureTime frameDescription
Percentage of time wherein white blood cell concentration is within the target rangeAfter randomizationPercentage of time wherein white blood cell concentration is within the target range 1.5 - 3.5 × 10\^9/L after randomization.

Secondary

MeasureTime frameDescription
Percentage of time wherein white blood cell concentration is < 1.0 or > 5.0 × 10^9/LAfter randomizationPercentage of time wherein white blood cell concentration is \< 1.0 or \> 5.0 × 10\^9/L after randomization

Countries

China

Contacts

CONTACTYahui Feng
fengyahui@ihcams.ac.cn022-23909051

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026