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NCT03817398 · ClinicalTrials.gov registry record · Phase 2
Stopping Tyrosine Kinase Inhibitors in Affecting Treatment-Free Remission in Patients With Chronic Phase Chronic Myeloid Leukemia
A Phase 2 study of Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, sponsored by Children's Oncology Group.
- Active
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
- 20
- Study locations
NCT03817398: Active Phase 2 study of Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, sponsored by Children's Oncology Group.
NCT03817398 is a Phase 2 study of Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 110 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03817398, a Phase 2 study of Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how stopping tyrosine kinase inhibitors will affect treatment-free remission in patients with chronic myeloid leukemia in chronic phase. When the level of disease is very low, it's called molecular remission. TKIs are a type of medication that help keep this level low. However, after being in molecular remission for a specific amount of time, it may not be necessary to take tyrosine kinase inhibitors. It is not yet known whether stopping tyrosine kinase inhibitors will help patients with chronic myeloid leukemia in chronic phase continue or re-achieve molecular remission.
Primary Outcome
The Kaplan Meier method will be used to estimate 2-year TFR along with a 95% confidence interval.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- OTHER Drug Withdrawn
- DRUG Tyrosine Kinase Inhibitor
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Mattel Children's Hospital UCLA - Los Angeles
- Valley Children's Hospital - Madera
- UCSF Benioff Children's Hospital Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- University of California Davis Comprehensive Cancer Center - Sacramento
- Rady Children's Hospital - San Diego - San Diego
Alabama
- Children's Hospital of Alabama - Birmingham
- USA Health Strada Patient Care Center - Mobile
Arizona
- Banner Children's at Desert - Mesa
- Banner University Medical Center - Tucson - Tucson
Colorado
- Children's Hospital Colorado - Aurora
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center - Denver
Arkansas
- Arkansas Children's Hospital - Little Rock
Connecticut
- Connecticut Children's Medical Center - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2019-11-08 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 2 |
What the registry record for NCT03817398 still lists
NCT03817398 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower).
The record links to 1 condition, with Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT03817398 names 20 study sites across 6 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT03817398 about?
NCT03817398 is a clinical study titled "Stopping Tyrosine Kinase Inhibitors in Affecting Treatment-Free Remission in Patients With Chronic Phase Chronic Myeloid Leukemia". This phase II trial studies how stopping tyrosine kinase inhibitors will affect treatment-free remission in patients with chronic myeloid leukemia in chronic phase. When the level of disease is very low, it's called molecular remission. TKIs are a type of medication that help keep this level low. Ho...
What is the current status of trial NCT03817398?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2019-11-08. Estimated completion is 2026-06-30.
What conditions does trial NCT03817398 study?
This clinical trial studies the following conditions: Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive.
What interventions are being tested in trial NCT03817398?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Drug Withdrawn (OTHER), Tyrosine Kinase Inhibitor (DRUG).
Who is sponsoring clinical trial NCT03817398?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03817398 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03817398's enrollment target sits among peer trials
110 632nd of 2000 higher than 1,361 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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