ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of CPX-351 in Newly Diagnosed Elderly AML Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00788892
Recruitment Status : Completed
First Posted : November 11, 2008
Results First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Acute Myeloid Leukemia
Interventions: Drug: CPX-351
Drug: Cytarabine
Drug: Daunorubicin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm A: CPX-351 First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3
Arm B: Cytarabine + Daunorubicin First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice

Participant Flow:   Overall Study
    Arm A: CPX-351   Arm B: Cytarabine + Daunorubicin
STARTED   85   41 
COMPLETED   36   18 
NOT COMPLETED   49   23 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population: All randomized participants who received at least one dose of study drug.

Reporting Groups
  Description
Arm A: CPX-351 First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3
Arm B: Cytarabine + Daunorubicin First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
Total Total of all reporting groups

Baseline Measures
   Arm A: CPX-351   Arm B: Cytarabine + Daunorubicin   Total 
Overall Participants Analyzed 
[Units: Participants]
 85   41   126 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.8  (4.63)   68.2  (4.88)   67.9  (4.69) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      32  37.6%      16  39.0%      48  38.1% 
Male      53  62.4%      25  61.0%      78  61.9% 


  Outcome Measures

1.  Primary:   Number of Participants With Complete Remission   [ Time Frame: Within 6 weeks of the last induction treatment ]

2.  Secondary:   Remission Duration/Time to Remission   [ Time Frame: Following achievement of CR over the study period ]

3.  Secondary:   Event Free Survival   [ Time Frame: Up to 1 year from randomization ]

4.  Secondary:   Overall Survival Rate at 1 Year   [ Time Frame: 1 year ]

5.  Secondary:   Rate of Stem Cell Transplant   [ Time Frame: Up to 1 year ]

6.  Secondary:   Aplasia Rate   [ Time Frame: Day 14 (1st Induction) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Associate Director, Clinical Trial Disclosure & Transparency
Organization: Jazz Pharmaceuticals
phone: 215-832-3750


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00788892     History of Changes
Other Study ID Numbers: CLTR0308-204
First Submitted: November 10, 2008
First Posted: November 11, 2008
Results First Submitted: September 3, 2017
Results First Posted: January 12, 2018
Last Update Posted: January 12, 2018