Study to Evaluate Nilotinib in Chronic Myelogenous Leukemia (CML) Patients With SubOptimal Response (MACS0911)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01043874
First received: January 5, 2010
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

To evaluate the major molecular response (MMR) rate at 12 months of nilotinib treatment on study in patients with Philadelphia Chromosome Positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP) who have a suboptimal molecular response to imatinib at 18 months or later.


Condition Intervention Phase
Philadelphia Chromosome Positive
Chronic Myelogenous Leukemia in Chronic Phase
Drug: Nilotinib
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IV Study of Nilotinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have Suboptimal Molecular Response on Imatinib

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To evaluate the MMR rate at 12 months of nilotinib treatment on study in patients with Ph+ CML in CP who have a suboptimal molecular response to imatinib at 18 months or later. [ Time Frame: 12 months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the MMR rate at 24 months of nilotinib treatment on study in patients with Ph+ CML in CP [ Time Frame: 24 months after treatment ] [ Designated as safety issue: No ]
  • To evaluate the time to and duration of MMR of nilotinib in patients with Ph+ CML in CP. [ Time Frame: month 12 and month 24 ] [ Designated as safety issue: No ]
  • To evaluate the safety profile of nilotinib in patients with Ph+ CML in CP. [ Time Frame: month 12 and month 24 ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: December 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nilotinib Drug: Nilotinib
Other Name: 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. Have been diagnosed with Ph+ CML-CP and receiving imatinib therapy.
  4. Patients with suboptimal molecular response to imatinib treatment continued for at least 18 months (first line therapy)

    Suboptimal molecular response defined as all of the following conditions:

    1. Patients who have achieved CCyR (0% Ph+ chromosomes).
    2. Patients who don't achieve MMR (MMR defined as BCR-ABL/ABL ratio of ≤ 0.1% on the International Scale as detected by RQ-PCR).

    The treatment with imatinib defined as:

    Dose of 300 mg or higher daily must be maintained for a minimum of 3 months prior to study entry.

  5. Patients who meet the following laboratory tests criteria:

    1. total bilirubin < 1.5 x ULN,
    2. SGOT and SGPT < 2.5 x ULN,
    3. creatinine < 1.5 x ULN,
    4. Serum amylase and lipase ≤ 1.5 x ULN,
    5. Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related.
    6. Serum potassium, phosphorus, magnesium and calcium ≥ LLN or correctable with supplements prior to the first dose of study drug.
  6. Written informed consent prior to any study related screening procedures being performed.

Exclusion Criteria:

  1. Prior accelerated phase or blast crisis CML.
  2. Previously documented T315I mutations.
  3. Presence of chromosomal abnormalities other than Ph+.
  4. Previous treatment with any other tyrosine kinase inhibitor except imatinib.
  5. Impaired cardiac function including any one of the following:

    1. Complete left bundle branch block
    2. Congenital long QT syndrome or family history of long QT syndrome
    3. History of or presence of significant ventricular or atrial tachyarrhythmias
    4. Clinically significant resting brachycardia (<50 bpm)
    5. QTcF > 450 msec on screening ECG
    6. Use of a ventricular-paced pacemaker
    7. Myocardial infarction during the last 12 months
    8. Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, unstable angina).
  6. Treatment with strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, St John's Wort), and the treatment cannot be discontinued or switched to a different medication prior to starting study drug. See Section 6.4.3 for complete list of these medications.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01043874

Locations
Japan
Novartis Investigative Site
Nagoya, Aichi, Japan, 464-8681
Novartis Investigative Site
Nagoya, Aichi, Japan, 453-8511
Novartis Investigative Site
Nagoya-city, Aichi, Japan, 466-8560
Novartis Investigative Site
Fukuoka-city, Fukuoka, Japan, 812-8582
Novartis Investigative Site
Kitakyushu, Fukuoka, Japan, 807-8556
Novartis Investigative Site
Kurume, Fukuoka, Japan, 830-0011
Novartis Investigative Site
Nishinomiya, Hyogo, Japan, 663-8501
Novartis Investigative Site
Kanazawa, Ishikawa, Japan, 920-8641
Novartis Investigative Site
Kumamoto City, Kumamoto, Japan, 860-8556
Novartis Investigative Site
Sendai-city, Miyagi, Japan, 983-8520
Novartis Investigative Site
Okayama-city, Okayama, Japan, 700-8558
Novartis Investigative Site
Osaka-city, Osaka, Japan, 545-8586
Novartis Investigative Site
OsakaSayama, Osaka, Japan, 589-8511
Novartis Investigative Site
Suita-city, Osaka, Japan, 565-0871
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan, 113-8519
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan, 113-8655
Novartis Investigative Site
Itabashi-ku, Tokyo, Japan, 173-8610
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan, 160-0023
Novartis Investigative Site
Tachikawa, Tokyo, Japan, 190-0014
Novartis Investigative Site
Ube, Yamaguchi, Japan, 755-8505
Novartis Investigative Site
Aomori, Japan, 030-8553
Novartis Investigative Site
Gifu, Japan, 501-1194
Novartis Investigative Site
Hiroshima, Japan, 734-8551
Novartis Investigative Site
Kyoto, Japan, 602-8566
Novartis Investigative Site
Nagasaki, Japan, 852-8501
Novartis Investigative Site
Okayama, Japan, 701-1192
Novartis Investigative Site
Saga, Japan, 849-8501
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01043874     History of Changes
Other Study ID Numbers: CAMN107FJP01
Study First Received: January 5, 2010
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration
Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
Chronic phase
Chronic myelogenous leukemia
CML
Philadelphia chromosome positive
Ph+
Nilotinib
CML-CP

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

ClinicalTrials.gov processed this record on April 16, 2014