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Recruiting

NCT Number: NCT07278882

Using Mobile Technology-assisted Outpatient Maintenance Therapy Pediatric ALL

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

Recruiting

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Key information

Conditions

Pediatric Acute Leukemia

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300020, China

Location status: Recruiting

Location contact

Yahui Feng

CONTACT

[email protected]

022-23608045

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

Health 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.

Behavioral

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.

Primary outcomes

  1. Percentage of time wherein white blood cell concentration is within the target range

    Time frame: After randomization

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

Secondary outcomes

  1. Percentage of time wherein white blood cell concentration is < 1.0 or > 5.0 × 10^9/L

    Time frame: After randomization

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yahui Feng

CONTACT

[email protected]

022-23909051

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 12, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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