Using Mobile Technology-assisted Outpatient Maintenance Therapy Pediatric ALL

NCT07278882 | Recruiting

• 1 other identifier: IIT2024105
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pediatric Acute Leukemia

Outcome Measures

Primary Outcomes (1)

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

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

  After randomization

Secondary Outcomes (1)

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

  After randomization

Study Arms (2)

Intervention group

EXPERIMENTAL

A mobile application classifies each subject's maintenance therapy dosing status as 'On Track', 'Orange Alert', or 'Red Alert' based on analysis of his/her electronic diary of medication and blood tests.

Behavioral: 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.

Control group

NO INTERVENTION

No intervention

Interventions

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.

Intervention group

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \< 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

Central Study Contacts

Yahui Feng

CONTACT

022-23909051; fengyahui@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 12, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 20, 2027
• Study Completion (Estimated): November 20, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)