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A Study Being Conducted at Multiple Locations to Compare Safety and Efficacy of Three Different Regimens; (1) High-Dose Lenalidomide; (2) Lenalidomide + Azacitidine; or (3) Azacitidine in Subjects ≥ 65 Years With Newly-Diagnosed Acute Myeloid Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01358734
First Posted: May 24, 2011
Last Update Posted: March 14, 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.
Information provided by (Responsible Party):
Celgene
Results First Submitted: April 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Acute Myeloid Leukemia
Acute Myelogenous Leukemia
Interventions: Drug: Azacitidine
Drug: Lenalidomide
Other: Best Supportive Care (BSC)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were centrally randomized 1:1:1 and stratified by the Eastern Cooperative Oncology Group (ECOG) performance score (0 to 1 versus 2) and peripheral blood blast count (<1 versus ≥ 1 x 10^9/L).

Reporting Groups
  Description
Lenalidomide Lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus best supportive care (BSC), including antibiotics and transfusions, at the investigator's discretion.
Azacitidine Plus Lenalidomide Azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
Azacitidine Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC

Participant Flow:   Overall Study
    Lenalidomide   Azacitidine Plus Lenalidomide   Azacitidine
STARTED   15   39   34 
Safety Population   14 [1]   38 [1]   32 [1] 
COMPLETED   0   2 [2]   5 [2] 
NOT COMPLETED   15   37   29 
Adverse Event                4                7                3 
Lack of Efficacy                0                1                3 
Withdrawal by Subject                1                6                3 
Death                3                7                2 
Progressive Disease                5                11                13 
Non-compliance with study drug                0                0                1 
Not Specified                2                5                4 
[1] The safety population includes all participants who received at least one dose of study drug.
[2] Includes participants still receiving study treatment



  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.
Intent To Treat (ITT) includes all randomized participants

Reporting Groups
  Description
Lenalidomide Lenalidomide 50 mg/day by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg daily PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily
Azacitidine + Lenalidomide Azacitidine 75 mg/m^2/ daily subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg daily PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
Azacitidine Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
Total Total of all reporting groups

Baseline Measures
   Lenalidomide   Azacitidine + Lenalidomide   Azacitidine   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   39   34   88 
Age 
[Units: Years]
Mean (Standard Deviation)
 77.6  (5.47)   75.5  (5.88)   74.8  (4.96)   75.97  (5.44) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      3  20.0%      17  43.6%      15  44.1%      35  39.8% 
Male      12  80.0%      22  56.4%      19  55.9%      53  60.2% 
Eastern Cooperative Oncology Group [1] 
[Units: Participants]
       
0 = (Fully Active)   4   4   10   18 
1 = (Restrictive but ambulatory)   9   28   17   54 
(Ambulatory but unable to work)   2   7   6   15 
3 = (Limited self care)   0   0   0   0 
4 = (Completely Disabled)   0   0   0   0 
Missing   0   0   1   1 
[1] Eastern Cooperative Oncology Group (ECOG) Performance Status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity)
Peripheral Blast Blood Count 
[Units: Participants]
       
<1 X 10^9L   11   31   27   69 
≥1 X 10^9L   4   8   7   19 


  Outcome Measures
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1.  Primary:   Kaplan Meier Estimates for One Year Survival   [ Time Frame: Up to 24 months ]

2.  Secondary:   Percentage of Participants With 30-day Treatment-related Mortality   [ Time Frame: 30 days ]

3.  Secondary:   Number of Participants With Treatment Emergent Adverse Events (TEAE)   [ Time Frame: Up to data cut-off of 01 May 2015; 36 months and 4 days ]

4.  Other Pre-specified:   Percentage of Participants Alive at One Year   [ Time Frame: Up to 12 months ]

5.  Secondary:   Remission Rate (CR + CRi)   [ Time Frame: Up to 74 months ]
Results not yet reported.   Anticipated Reporting Date:   04/2019  

6.  Secondary:   Duration of Remission (DoR)   [ Time Frame: Up to 74 months ]
Results not yet reported.   Anticipated Reporting Date:   04/2019  

7.  Secondary:   Cytogenetic Complete Remission Rate (CRc)   [ Time Frame: Up to 74 months ]
Results not yet reported.   Anticipated Reporting Date:   04/2019  

8.  Secondary:   Percentage of Participants With an Overall Response Rate (CR +CRi+ PR)   [ Time Frame: Up to 74 months ]
Results not yet reported.   Anticipated Reporting Date:   04/2019  

9.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Up to 74 months ]
Results not yet reported.   Anticipated Reporting Date:   04/2019  

10.  Secondary:   Event-Free Survival (EFS)   [ Time Frame: Up to 74 months ]
Results not yet reported.   Anticipated Reporting Date:   06/2019  

11.  Secondary:   Relapse-Free Survival (RFS)   [ Time Frame: Up to 74 months ]
Results not yet reported.   Anticipated Reporting Date:   04/2019  


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Anne McClain, Senior Manager, Clinical Trial Disclosure
Organization: Celgene Corporation
phone: 888-260-1599
e-mail: ClinicalTrialDisclosure@celgene.com



Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01358734     History of Changes
Other Study ID Numbers: CC-5013-AML-001
First Submitted: May 19, 2011
First Posted: May 24, 2011
Results First Submitted: April 4, 2016
Results First Posted: July 4, 2016
Last Update Posted: March 14, 2017