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Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase (`MACS1252)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01061177
First Posted: February 2, 2010
Last Update Posted: February 24, 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):
Novartis ( Novartis Pharmaceuticals )
Results First Submitted: August 3, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: CML 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
ITT: intent to treat; b3a2 & b2a2 +ve are categories of BCR-ABL transcripts (BCR-ABL1 is an abnormal gene found in chronic myeloid leukemia and acute lymphoblastic leukemia patients; CyR (Ph+ Patients Only) = cytogenic response for Philadelphia positive patients only.

Reporting Groups
  Description
Nilotinib This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.

Participant Flow:   Overall Study
    Nilotinib
STARTED   1089 
ITT_MR (b2a2 &/or b3a2 +ve Pts Only)   1056 
ITT_CyR (Ph+ Patients Only)   983 
COMPLETED   881 
NOT COMPLETED   208 
Adverse Event                117 
Withdrawal by Subject                27 
Disease progression                17 
Protocol Violation                11 
Lost to Follow-up                9 
New cancer therapy                9 
Abnormal laboratory values                6 
Abnormal test procedure results                4 
Administratie problems                4 
Death                4 



  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.
The intent-to-treat (ITT) population consisted of all participants who received at least one dose of study drug.

Reporting Groups
  Description
Nilotinib This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.

Baseline Measures
   Nilotinib 
Overall Participants Analyzed 
[Units: Participants]
 1089 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.6  (14.87) 
Gender 
[Units: Participants]
Count of Participants
 
Female      447  41.0% 
Male      642  59.0% 
Race/Ethnicity, Customized 
[Units: Participants]
 
Caucacian   1045 
Black   6 
Oriental   5 
Native American   2 
Other   31 
Weight at baseline 
[Units: Kg]
Mean (Standard Deviation)
 77.47  (15.730) 
ECOG performance score [1] 
[Units: Participants]
 
No restrictions (0)   867 
Only light work (1)   199 
Only self care (2)   21 
Limited self care (3)   0 
Completely disabled (4)   0 
Missing   2 
[1] ECOG = Eastern Cooperative Oncology Group


  Outcome Measures
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1.  Primary:   Percentage of Participants With Molecular Response (MR4^0) at 18 Months   [ Time Frame: at 18 months ]

2.  Secondary:   Percentage of Participants Free From Progression to Accelerated Phase/Blast Crisis (AP/BC) at 12 and 24 Months   [ Time Frame: at 12 and 24 months ]

3.  Secondary:   Rate of Event Free Survival at 12 and 24 Months   [ Time Frame: at 12 and 24 months ]

4.  Secondary:   Percentage of Participants With Major Molecular Response (MMR) at, as Well as by, 12 and 24 Months   [ Time Frame: 12 months, 24 months ]

5.  Secondary:   Percentage of Participants With Complete Cytogenetic Response (CCyR) at, as Well as by, 12 and 24 Months   [ Time Frame: 12 and 24 months ]

6.  Secondary:   Percentage of Participants With Major Cytogenetic Response (MCyR) at, as Well as by, 12 and 24 Months   [ Time Frame: 12 and 24 months ]

7.  Secondary:   Percentage of Participants Free From Progression to AP/BC With MR4^0 at 12 Months   [ Time Frame: at 12 months ]

8.  Secondary:   Percentage of Participants With Event Free Survival in Participants Achieving MR4^0 at 12 Months   [ Time Frame: at 12 months ]

9.  Secondary:   Percentage of Participants With Progression Free Survival (PFS) at 12 and 24 Months   [ Time Frame: 12 months, 24 months ]

10.  Secondary:   Rate of Molecular Response (MR4^0) at, as Well as by, 12 and 24 Months   [ Time Frame: 12 and 24 months ]

11.  Secondary:   Rate of Molecular Response (MR4^5) at, as Well as by, 12 and 24 Months   [ Time Frame: 12 and 24 months ]

12.  Secondary:   Rate of Complete Hematologic Response (CHR) at, as Well as by, 12 and 24 Months   [ Time Frame: 12 months, 24 months ]

13.  Secondary:   Percentage of Participants With Overall Survival at 12 and 24 Months   [ Time Frame: 12 months, 24 months ]

14.  Secondary:   Rate of Molecular Response (MR4^0) by 18 Months   [ Time Frame: by 18 months ]

15.  Secondary:   Rate of Molecular Response (MR4^5) by 18 Months   [ Time Frame: by 18 months ]

16.  Secondary:   Percentage of Participants With Progression Free Survival in Participants Achieving MR4^0 at 12 Months   [ Time Frame: 12 months ]


  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 Pharmaceuticals
phone: 862-778-8300
e-mail: trialandresults.registry@novartis.com


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

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01061177     History of Changes
Other Study ID Numbers: CAMN107EIC01
2009-017775-19 ( EudraCT Number )
First Submitted: February 1, 2010
First Posted: February 2, 2010
Results First Submitted: August 3, 2015
Results First Posted: February 24, 2017
Last Update Posted: February 24, 2017