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Study Assessing Deep Molecular Response in Adult Patients With CML in Chronic Phase Treated With Nilotinib Firstline. (NILOdeepR)

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: NCT02546674
Recruitment Status : Active, not recruiting
First Posted : September 11, 2015
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The main purpose of this study is evaluation of deep molecular response (MR4.5; BCR-ABL IS < 0.0032%) after 24 months of therapy with nilotinib in newly diagnosed patients with chronic phase CML. Via the use of MR4.5 EUTOS ('European Treatment and Outcome Study for CML') laboratories adequate and reliable molecular monitoring as a key parameter for assessing molecular milestones is fostered. Furthermore this trial aims to investigate early prediction of outcome in newly diagnosed patients with nilotinib by assessing the individual decline of BCR-ABL transcripts. Quality of life will bemeasured via use of the EORTC CML-24 questionnaire.

Condition or disease Intervention/treatment Phase
Chronic Myeloid Leukemia Drug: Nilotinib Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV Single Arm, Multicenter, Open-label Study Assessing Deep Molecular Response in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive CML in Chronic Phase After Two Years of Treatment With Nilotinib 300mg BID
Actual Study Start Date : February 18, 2016
Estimated Primary Completion Date : February 22, 2021
Estimated Study Completion Date : February 22, 2021


Arm Intervention/treatment
Experimental: Nilotinib
Patients with newly diagnosed CML in chronic phase will be enrolled.
Drug: Nilotinib
Nilotinib will be prescribed by the investigator according to the patient's medical need.




Primary Outcome Measures :
  1. Proportion of patients that achieve deep molecular response MR4.5 (IS) at 24 months of study treatment, measured in a standardized EUTOS MR4.5 laboratory [ Time Frame: 24 months ]
    The primary efficacy variable is the rate of MR4.5 at 24 months of study treatment measured in a standardized EUTOS MR4.5 laboratory. The rate of MR4.5 (IS) at 24 months of study treatment will be computed by dividing the number of patients who fit the definition of response at 24 months by the total number of patients in the analysis set.


Secondary Outcome Measures :
  1. Proportion of patients with MMR at 12 months of study treatment [ Time Frame: 12 months ]
    The rate of MMR at 12 months of study treatment will be computed by dividing the number of patients who fit the definition of response at 12 months by the total number of patients in the analysis set

  2. Proportion of patients with CCyR at 6 months of study treatment [ Time Frame: 6 months ]
    Rate of CCyR at 6 months of study treatment will be calculated by dividing the number of patients who fit the definition of response at 6 month by the total number of Ph+ patients in the analysis set

  3. Progression-free survival [ Time Frame: up to 24 months ]
    Progression-free survival is defined as the time from the date of start of study treatment to the date of event defined as the first documented disease progression to AP/BC or the date of death from any cause, whichever is earlier

  4. Proportion of patients with MR4 at 24 months of study treatment [ Time Frame: 24 months ]
    The rate of MR4 (IS) at 24 months of study treatment will be computed by dividing the number of patients who fit the definition of response at 24 months by the total number of patients in the analysis set

  5. Individual reduction of BCR-ABL transcripts [ Time Frame: 3 months ]
    For determination of actual individual decline of transcripts a ratio will be established given by BCR-ABL/GUS at 3 months divided by BCR-ABL/GUS at diagnosis and referred to as 3-month reduction ratio.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with newly diagnosed (within 6 months) Philadelphia chromosome positive CML in chronic phase; Patients must be previously untreated for CML with the exception of 6 months treatment with hydroxyurea and a maximum of 6 weeks treatment with imatinib

Exclusion Criteria:

-Known impaired cardiac function like long QT syndrome, history of myocardial infarction or unstable angina in the past 12 months. Patients who are pregnant or breast feeding.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02546674


Locations
Show Show 71 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals

Additional Information:
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02546674    
Other Study ID Numbers: CAMN107ADE20
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Chronic Myeloid Leukemia
Nilotinib
Molecular Response
MR4.5
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases