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NCT03589326 · ClinicalTrials.gov registry record · Phase 3
A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia
A Phase 3 study of Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL), sponsored by Takeda.
- Active
- Registry status
- Phase 3
- Development phase
- 245
- Enrollment target
- 20
- Study locations
NCT03589326 is a Phase 3 study of Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL) that is active but no longer recruiting, run by Takeda. The registered enrollment target is 245 participants. The trial reports 20 study locations across 13 states.
The verdict
NCT03589326, a Phase 3 study of Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL), is active but no longer recruiting, sponsored by Takeda.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 245 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. 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 408 total studies on file at ClinicalTrials.gov.
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.
NCT03589326 reports 20 study locations spanning 13 distinct geographic areas - top geographies include New York, California, Indiana.
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).
What interventions are being tested in trial NCT03589326?
The interventions under investigation include: Dexamethasone (DRUG), Vincristine (DRUG), Cytarabine (DRUG), Imatinib (DRUG), Ponatinib (DRUG).
Who is sponsoring clinical trial NCT03589326?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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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