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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00980018
First received: September 16, 2009
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Chronic Myelogenous Leukemia
Drug: Nilotinib
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Assess CCyR by bone marrow cytogenics

  • 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 ] [ Designated as safety issue: No ]
    Measure MMR at the end of Cycles

  • 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. ] [ Designated as safety issue: No ]
  • Durability of cytogenetic and molecular response [ Time Frame: after the switch to nilotinib until the end of the study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: December 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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,

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00980018

Locations
United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72753
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
Texas Oncology, P.A. Texas Oncology - Sugar Land
Dallas, Texas, United States, 75246
Presbyterian Hospital of Dallas TexasOncology@PresbyterianHosp
Dallas, Texas, United States, 75231
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
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00980018     History of Changes
Other Study ID Numbers: CAMN107AUS17
Study First Received: September 16, 2009
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
CML
Leukemia
Tasigna
nilotinib
AMN107
CML-CP
Chronic Phase

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014