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NCT01696084 · ClinicalTrials.gov registry record · Phase 3
Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia
A Phase 3 study of High Risk Acute Myeloid Leukemia, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 309
- Enrollment target
- 20
- Study locations
NCT01696084: Completed Phase 3 study of High Risk Acute Myeloid Leukemia, sponsored by Jazz Pharmaceuticals.
NCT01696084 is a Phase 3 study of High Risk Acute Myeloid Leukemia that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 309 participants, below the 701-participant average among 4 other High Risk Acute Myeloid Leukemia trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01696084, a Phase 3 study of High Risk Acute Myeloid Leukemia, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 309 participants
- Enrollment target
- 20
- Study locations
Study Summary
To confirm the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients (60-75 yrs) with high risk (secondary) Acute Myeloid Leukemia. The primary efficacy endpoint will be overall survival.
Primary Outcome
Overall survival was measured from the date of randomization to death from any cause, subjects not known to have died by the last follow-up were censored on the date they were last known to be alive.
Conditions Studied
Interventions
- DRUG CPX-351
- DRUG 7+3 (cytarabine and daunorubicin)
Study Locations (20)
California
- UCLA - Los Angeles
- University of CA San Diego - San Diego
- Stanford University - Stanford
Illinois
- Northwestern University - Chicago
- Rush University Medical Center - Chicago
- University of Chicago - Chicago
Florida
- University of Florida - Gainesville
- H. Lee Moffitt Cancer Center - Tampa
Missouri
- University of Missouri - Columbia
- Washington University - St Louis
Alabama
- University of Alabama at Birmingham - Birmingham
Connecticut
- Yale University - New Haven
Georgia
- Northside Hospital - Atlanta
Indiana
- Franciscan St. Francis Health - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 309 participants |
| Start Date | 2012-12-13 |
| Est. Completion | 2015-12-31 |
| Phase | Phase 3 |
What the finished NCT01696084 record still lists
NCT01696084 is an interventional study that assigns participants to a tested intervention. The registered 309 participants enrollment target is mid-sized for trials with a published cap, below the 701-participant average among 4 other High Risk Acute Myeloid Leukemia trials with a reported enrollment target (56% lower).
The record links to 1 condition, with High Risk Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which CPX-351 is the first listed.
NCT01696084 names 20 study sites across 14 states, led by California, Illinois, Florida.
Frequently Asked Questions
What is clinical trial NCT01696084 about?
NCT01696084 is a clinical study titled "Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia". To confirm the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients (60-75 yrs) with high risk (secondary) Acute Myeloid Leukemia. The primary efficacy endpoint will be overall survival.
What is the current status of trial NCT01696084?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 309 participants. The study started on 2012-12-13. Estimated completion is 2015-12-31.
What conditions does trial NCT01696084 study?
This clinical trial studies the following conditions: High Risk Acute Myeloid Leukemia.
What interventions are being tested in trial NCT01696084?
The interventions under investigation include: CPX-351 (DRUG), 7+3 (cytarabine and daunorubicin) (DRUG).
Who is sponsoring clinical trial NCT01696084?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01696084 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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