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A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia
NCT03589326 · View on ClinicalTrials.gov ↗
Study Summary
In this study, adults with newly-diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) will receive first-line therapy of ponatinib or imatinib. The main aim of this study is to compare the number of participants on each treatment that show no signs of disease. Participants will take tablets of either ponatinib or imatinib at the same time each day combined with reduced-intensity chemotherapy for up to 20 months. Then, they will continue with single-agent therapy (ponatinib or imatinib) until they meet the discontinuation criteria from the study.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Vincristine
- DRUG Cytarabine
- DRUG Imatinib
- DRUG Ponatinib
Study Locations (20)
New York
- Roswell Park Cancer Institute — Buffalo
- Monter Cancer Center — New Hyde Park
- Stony Brook University Medical Center — Stony Brook
California
- City of Hope - Duarte — Duarte
- University of California Los Angeles — Los Angeles
Indiana
- Indiana University — Indianapolis
- Indiana Blood & Marrow Transplantation — Indianapolis
Texas
- The University of Texas MD Anderson Cancer Center — Houston
- Methodist Hospital — San Antonio
Other
- Sanatorio Allende — Córdoba
- Hospital Privado Centro Medico de Cordoba — Córdoba
Victoria
- Box Hill Hospital — Box Hill
- Monash Medical Centre — Clayton
Alabama
- University of Alabama at Birmingham — Birmingham
Georgia
- Augusta University Georgia Cancer Center — Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2018-10-04 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03589326
The ClinicalTrials.gov registry entry for NCT03589326 describes a study currently listed as active not recruiting. It is categorized as Phase 3, 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 245 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 387 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 Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL) appearing as the primary indexed condition, and to 5 interventions — of which Dexamethasone 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: NCT03589326 reports 20 study locations spanning 13 distinct geographic areas — top geographies include New York, California, Indiana. 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 NCT03589326 about?
NCT03589326 is a clinical study titled "A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia". In this study, adults with newly-diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) will receive first-line therapy of ponatinib or imatinib. The main aim of this study is to compare the number of participants on each treatment that show no signs of disease. Particip...
What is the current status of trial NCT03589326?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 245 participants. The study started on 2018-10-04. Estimated completion is 2027-07-31.
What conditions does trial NCT03589326 study?
This clinical trial studies the following conditions: Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03589326?
The interventions under investigation include: Dexamethasone (DRUG), Vincristine (DRUG), Cytarabine (DRUG), Imatinib (DRUG), Ponatinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03589326?
This trial is sponsored by Takeda, which has 387 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03589326 being conducted?
This trial has 20 study locations across Alabama, California, Georgia, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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