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An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment (MACS0999)

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ClinicalTrials.gov Identifier: NCT00980018
Recruitment Status : Completed
First Posted : September 18, 2009
Last Update Posted : April 15, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this exploratory study will be to examine changes in chronic low grade chronic adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading, when patients are switched from imatinib to nilotinib therapy.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Trial to Assess the Improvement of Chronic Low-grade Non-hematologic Adverse Events Experienced by Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Treated With Imatinib When Switched to Nilotinib Treatment
Study Start Date : December 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012


Arm Intervention/treatment
Experimental: nilotinib
To measure improvement of (CTCAE grading scale) of imatinib related chronic low grade non hematologic Adverse Event after switch to treatment with nilotinib at End of Cycle 3
Drug: Nilotinib
participants will take nilotinib 400mg twice daily by mouth every morning and every evening approximately 12 hours apart. Participants will take two 200mg capsules at each dosing. Nilotinib is taken on an empty stomach with 8 ounces of water. No food is to be eaten for 2 hours prior to the nilotinib dose or for one hour following the dose.
Other Name: Tasigna, nilotinib, AMN107,




Primary Outcome Measures :
  1. Improvement of (CTCAE grading scale) of imatinib related chronic low grade non hematologic Adverse Event after switch to treatment with nilotinib at End of Cycle 3 [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Rate of Complete Cytogenetic Response (CCyR) present at baseline [ Time Frame: 6, 12, and 18 months after starting imatinib. FISH wil be conducted at the end of cycles 1,2,3,6,9,12 after the switch to nilotinib ]
    Assess CCyR by bone marrow cytogenics

  2. Rate of a Major Molecular Response (MMR) after the switch in the therapy [ Time Frame: 1,2,3,6,9,12 after the switch to nilotinib ]
    Measure MMR at the end of Cycles

  3. Magnitude of Bcr-Abl change after the switch in therapy [ Time Frame: At the end of cycles 1,2,3,6,9, and 12 after the switch to nilotinib. ]
  4. Durability of cytogenetic and molecular response [ Time Frame: after the switch to nilotinib until the end of the study ]
  5. Time to optimal imatinib-related adverse event improvement [ Time Frame: time to first documented and optimal improvement of adverse events associated with imatinib and to the end of the study ]


Information from the National Library of Medicine

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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:

  1. Male or female patients ≥ 18 years of age
  2. ECOG 0, 1, or 2
  3. Diagnosis of CML-CP associated with Bcr-Abl quantifiable by RQ-PCR (IS)
  4. Patients must be an imatinib responder and achieved the following efficacy milestones as appropriate for the length of time on imatinib therapy as per protocol
  5. CML-CP patients initiated on any dose of imatinib
  6. Ability to provide written informed consent prior to any study related screening procedures being done

Exclusion Criteria:

  1. Loss of CHR or cytogenetic response
  2. Prior accelerated phase or blast phase CML
  3. Previously documented T315I mutation
  4. Presence of chromosomal abnormalities (trisomy 8) and/or clonal evolution other than Ph+.
  5. Previous treatment with any other tyrosine kinase inhibitor except for imatinib.
  6. Treatment with other investigational agents within 30 days of Day 1.
  7. History of non-compliance to medical regimens or inability to grant consent.
  8. Women who are pregnant, breast feeding, or of childbearing potential without a negative serum test at baseline. Male or female patients of childbearing potential unwilling to use contraceptive precautions throughout the trial and 3 months following discontinuation of study drug. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Women of childbearing potential must have a negative serum pregnancy test prior to the first dose of nilotinib.

Other protocol-defined inclusion/exclusion criteria may apply


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): NCT00980018


Locations
Show Show 23 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00980018    
Other Study ID Numbers: CAMN107AUS17
First Posted: September 18, 2009    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 2015
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
CML
Leukemia
Tasigna
nilotinib
AMN107
CML-CP
Chronic Phase
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action