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Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia (301)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01696084
First Posted: September 28, 2012
Last Update Posted: October 2, 2017
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.
Collaborator:
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Jazz Pharmaceuticals
Results First Submitted: September 3, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: High Risk Acute Myeloid Leukemia
Interventions: Drug: CPX-351
Drug: 7+3 (cytarabine and daunorubicin)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Arm A (CPX-351) Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
Arm B (7+3) Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.

Participant Flow:   Overall Study
    Arm A (CPX-351)   Arm B (7+3)
STARTED   153   156 
COMPLETED   22   10 
NOT COMPLETED   131   146 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Arm A (CPX-351) Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
Arm B (7+3) Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
Total Total of all reporting groups

Baseline Measures
   Arm A (CPX-351)   Arm B (7+3)   Total 
Overall Participants Analyzed 
[Units: Participants]
 153   156   309 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.8  (4.19)   67.7  (4.1)   67.7  (4.14) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      59  38.6%      60  38.5%      119  38.5% 
Male      94  61.4%      96  61.5%      190  61.5% 


  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: From the date of randomization to death from any cause ]

2.  Secondary:   Proportion of Subjects With a Response   [ Time Frame: Post Induction ]

3.  Secondary:   Event-free Survival   [ Time Frame: From the date of randomization to the date that persistent disease was documented or the date of relapse after CR or death, whichever came first ]

4.  Secondary:   Remission Duration   [ Time Frame: From the date of achievement of a remission until the date of relapse or death from any cause ]

5.  Secondary:   Rate of Achieving Morphologic Leukemia-free State   [ Time Frame: Day 14 ]

6.  Secondary:   Proportion of Subjects Receiving a Stem Cell Transplant   [ Time Frame: Post Induction ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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
e-mail: tom.chmielewski@jazzpharma.com


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

Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01696084     History of Changes
Other Study ID Numbers: CLTR0310-301
First Submitted: September 26, 2012
First Posted: September 28, 2012
Results First Submitted: September 3, 2017
Results First Posted: October 2, 2017
Last Update Posted: October 2, 2017