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Stopping Tyrosine Kinase Inhibitors in Affecting Treatment-Free Remission in Patients With Chronic Phase Chronic Myeloid Leukemia
NCT03817398 · View on ClinicalTrials.gov ↗
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.
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- OTHER Drug Withdrawn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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03817398
The ClinicalTrials.gov registry entry for NCT03817398 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 318 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03817398 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03817398?
This trial is sponsored by Children's Oncology Group, which has 318 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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