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NCT01883362 · ClinicalTrials.gov registry record · Phase 2
Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML
A Phase 2 study of Acute Myeloid Leukemia, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 19
- Study locations
NCT01883362 is a Phase 2 study of Acute Myeloid Leukemia that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 60 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (48% lower). The trial reports 19 study locations across 16 states.
The verdict
NCT01883362, a Phase 2 study of Acute Myeloid Leukemia, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 19
- Study locations
Study Summary
To determine if the addition of midostaurin (PKC412) to Standard of Care (SOC) therapy reduces relapse in FLT3-ITD mutated AML patients receiving an allogenetic hematopoietic stem cell transplant,
Conditions Studied
Interventions
- OTHER Standard of Care
- DRUG Midostaurin
Study Locations (19)
California
- University of California San Diego Moores Cancer Center - La Jolla
- University of California at Los Angeles Oncology - Los Angeles
Tennessee
- Tennessee Oncology Sarah Cannon Research Inst. - Nashville
- Vanderbilt Univeristy Oncology - Nashville
Texas
- Baylor Health Care System/Sammons Cancer Center Oncology - Dallas
- Texas Transplant Physicians Group Oncology 2 - San Antonio
Colorado
- SCRI- Colorado Blood Cancer Institute - Denver
Florida
- H Lee Moffitt Cancer Center and Research Institute Oncology - Tampa
Georgia
- Northside Hospital - Atlanta
Illinois
- University of Chicago Medical Center - Chicago
Michigan
- Karmanos Cancer Institute Karmanos - Wayne State - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2014-02-06 |
| Est. Completion | 2018-04-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01883362
The ClinicalTrials.gov registry entry for NCT01883362 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (48% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.
NCT01883362 reports 19 study locations spanning 16 distinct geographic areas - top geographies include California, Tennessee, Texas.
Frequently Asked Questions
What is clinical trial NCT01883362 about?
NCT01883362 is a clinical study titled "Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML". To determine if the addition of midostaurin (PKC412) to Standard of Care (SOC) therapy reduces relapse in FLT3-ITD mutated AML patients receiving an allogenetic hematopoietic stem cell transplant,
What is the current status of trial NCT01883362?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2014-02-06. Estimated completion is 2018-04-30.
What conditions does trial NCT01883362 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT01883362?
The interventions under investigation include: Standard of Care (OTHER), Midostaurin (DRUG).
Who is sponsoring clinical trial NCT01883362?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01883362 being conducted?
This trial has 19 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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