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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)

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. Identifier: NCT00980018
Recruitment Status : Completed
First Posted : September 18, 2009
Last Update Posted : April 15, 2015
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

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 identifier (NCT number): NCT00980018

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United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
Hematology Oncology Services of Arkansas SC
Little Rock, Arkansas, United States, 72205
United States, California
USC Norris Cancer Center LAC & USC Medical Center
Los Angeles, California, United States, 90033
Southwest Cancer Care Murrieta
Poway, California, United States, 92064
United States, Colorado
Rocky Mountain Cancer Centers RMCC - Aurora
Greenwood Village, Colorado, United States
United States, Florida
Florida Cancer Institute
New Port Richey, Florida, United States, 34655
Cancer Centers of Florida PA Cancer Centers of FL-Orlando-4
Ocoee, Florida, United States, *see dep*
United States, Illinois
Stroger Cook County Hospital John H. Stroger Hospital
Chicago, Illinois, United States, 60612
United States, Indiana
St. Francis Hospital and Health Centers IndianaBlood&MarrowTransplantn
Beech Grove, Indiana, United States, 46107
United States, Maryland
St. Agnes Hospital
Baltimore, Maryland, United States, 21229
United States, Missouri
St. Louis University Cancer Center
St. Louis, Missouri, United States, 63110
United States, Oregon
Northwest Cancer Specialists Salmon Creek Office
Portland, Oregon, United States, 97210
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Tennessee
The Jones Clinic
Germantown, Tennessee, United States, 38138
United States, Texas
Texas Oncology, P.A.
Bedford, Texas, United States, 76022
Presbyterian Hospital of Dallas TexasOncology@PresbyterianHosp
Dallas, Texas, United States, 75231
Texas Oncology Texas Oncology - Sugar Land
Dallas, Texas, United States, 75246
MD Anderson Cancer Center/University of Texas
Houston, Texas, United States, 77031
Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)
San Antonio, Texas, United States, 78229
Canada, Ontario
Novartis Investigative Site
Brampton, Ontario, Canada, L6R 3J7
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada, H1T 2M4
Novartis Investigative Site
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00980018     History of Changes
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 ):
Chronic Phase

Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action