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CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib (MACS1428)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01227577
First received: October 21, 2010
Last updated: January 11, 2016
Last verified: January 2016
Results First Received: November 19, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Myelogenous Leukemia in Chronic Phase
Intervention: Drug: Nilotinib

  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
No text entered.

Reporting Groups
  Description
Nilotinib Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.

Participant Flow:   Overall Study
    Nilotinib  
STARTED     128  
COMPLETED     93  
NOT COMPLETED     35  
Protocol deviation                 3  
Death                 3  
Administrative problems                 2  
Lost to Follow-up                 1  
Withdrawal by Subject                 4  
Lack of Efficacy                 5  
Adverse Event                 17  



  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.
No text entered.

Reporting Groups
  Description
Nilotinib Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.

Baseline Measures
    Nilotinib  
Number of Participants  
[units: participants]
  128  
Age  
[units: Years]
Mean (Standard Deviation)
  55.6  (14.99)  
Gender  
[units: Participants]
 
Female     64  
Male     64  



  Outcome Measures
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1.  Primary:   Number of Participants With Confirmed Complete Molecular Response (CMR)   [ Time Frame: 4 years ]

2.  Secondary:   Number of Participants With Complete Cytogenetic Response (CCyR) and Major Molecular Response (MMR)   [ Time Frame: 4 years ]

3.  Secondary:   Time to CMR, CCyR and MMR   [ Time Frame: 4 years ]

4.  Secondary:   Duration of CMR, CCyR and MMR   [ Time Frame: 4 years ]

5.  Secondary:   Number of Participants With Progression to Accelerated Phase/Blastic Crisis (AP/BC)   [ Time Frame: 4 years ]

6.  Secondary:   Time to Progression of AP/BC   [ Time Frame: 4 years ]

7.  Secondary:   Number of Participants With Loss of CCyR, MMR and CMR   [ Time Frame: 4 years ]

8.  Secondary:   Number of Participants With CMR Who Were Dosed to 400 mg b.i.d.   [ Time Frame: 4 years ]

9.  Secondary:   Event-free Survival, Progression-free Survival and Overall Survival   [ Time Frame: 4 years ]


  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 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: Study Director
Organization: Novartis
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01227577     History of Changes
Other Study ID Numbers: CAMN107AUS28
Study First Received: October 21, 2010
Results First Received: November 19, 2015
Last Updated: January 11, 2016
Health Authority: United States: Food and Drug Administration