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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 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.

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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.

Conditions Studied

High Risk Acute Myeloid Leukemia

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

FieldValue
Enrollment Target 309 participants
Start Date 2012-12-13
Est. Completion 2015-12-31
Phase Phase 3

Sponsor

Jazz Pharmaceuticals

128 total trials

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What the Registry Record Tells You About NCT01696084

The ClinicalTrials.gov registry entry for NCT01696084 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 309 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 701-participant average among 4 other High Risk Acute Myeloid Leukemia trials with a reported enrollment target (56% lower). The listed sponsor is Jazz Pharmaceuticals, which has 128 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.