NCT06446661

Brief Summary

The purpose of this section is to learn how text message reminders might help with regularly taking chemotherapy medications for Adolescents and Adults with Acute Lymphoblastic leukemia (ALL).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
18mo left

Started Dec 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
2.5 years until next milestone

Study Start

First participant enrolled

December 15, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2028

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

May 31, 2024

Last Update Submit

March 2, 2026

Conditions

Keywords

Oral Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • To compare adherence to oral chemotherapy with mercaptopurine and methotrexate

    To compare adherence to oral mercaptopurine and methotrexate during the first 84-day cycle of maintenance therapy for patients with ALL on pediatric-based regimens between those who receive the high intensity text message intervention and those who receive standard of care.

    84 days

Secondary Outcomes (1)

  • To describe the relationship between oral chemotherapy adherence and patient factors

    1 year

Other Outcomes (2)

  • To compare percentage of time during maintenance at goal absolute neutrophil count (ANC) and platelet count for patients

    1 year

  • To compare clinical outcomes during and after maintenance therapy for AYA patients

    1 year

Study Arms (2)

High Intensity

ACTIVE COMPARATOR

Receives high-intensity text messaging for 2 cycles of treatment

Other: High Intensity

Low Intensity

ACTIVE COMPARATOR

Receives no texts for 1st cycle and low-intensity texts for 2nd cycle

Other: No Text MessagingsOther: Low Intensity Text Messaging

Interventions

Weekly Texts

Low Intensity

Daily texts

High Intensity

Standard Care

Low Intensity

Eligibility Criteria

Age15 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age of 15-39 years-old at the time of initial ALL diagnosis
  • Diagnosed with ALL
  • Currently receiving treatment with pediatric-based regimen that includes maintenance with mercaptopurine and methotrexate (e.g., CALGB 10403). Study participation begins with the start of maintenance, so enrollment occurs prior to the start of maintenance.

You may not qualify if:

  • Patient or caregiver who would receive text message reminders does not have a cell phone that receives text messages
  • Patient does not wish to participate
  • Text messages will be crafted in the patient's preferred language for medical communication, so English fluency is not an enrollment requirement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Wendy Stock

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2024

First Posted

June 6, 2024

Study Start (Estimated)

December 15, 2026

Primary Completion (Estimated)

June 15, 2027

Study Completion (Estimated)

June 15, 2028

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Study results including PHI such as dates, assigned study ID, and initials may be shared with researchers and their teams at other sites as part of required safety reporting notifications (e.g. serious events/unanticipated problems, or other reportable events). Final reports (no PHI) may also be shared. Names and medical record numbers will not be shared externally. Data will only be shared for analysis purposes.

Locations