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)

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

Study Overview

• Status: Recruiting
• Conditions: Pediatric Acute Leukemia
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yahui Feng; Phone Number: 022-23909051; Email: fengyahui@ihcams.ac.cn

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300020
      • Recruiting
      • Institute of Hematology & Blood Diseases Hospital
      • Contact: Yahui Feng; Phone Number: 022-23608045; Email: fengyahui@ihcams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; No intervention
Experimental: Intervention group; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of time wherein white blood cell concentration is < 1.0 or > 5.0 × 10^9/L	Percentage of time wherein white blood cell concentration is < 1.0 or > 5.0 × 10^9/L after randomization	After randomization

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): November 20, 2027
• Study Completion (Estimated): November 20, 2027

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IIT2024105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No