Efficacy and Safety of Nilotinib Patients With Newly Diagnosed CML - CP (Chronic Myelogenous Leukemia - Chronic Phase) (PHCHBS-WD4070)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00718263
Recruitment Status : Recruiting
First Posted : July 18, 2008
Last Update Posted : October 25, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study will evaluate the safety and tolerability of nilotinib after failure of imatinib therapy or imatinib therapy after nilotinib failure.

Condition or disease Intervention/treatment Phase
Myelogenous Leukemia, Chronic Drug: Nilotinib Drug: Imatinib Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extension Study to a Phase III Multi-center, Open-label, Randomized Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Study Start Date : April 2008
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Arm Intervention/treatment
Experimental: nilotinib Drug: Nilotinib
Active Comparator: imatinib Drug: Imatinib

Primary Outcome Measures :
  1. To compare the efficacy (MMR rate at 12 months) of nilotinib at 400mg/300mg BID with that of Gleevec/Glivec 400 mg QD in newly diagnosed, previously untreated Philadelphia chromosome-positive CML-CP patients. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. To compare the rate of durable MMR at 24 months, which is defined as the proportion of patients who have achieved MMR by 12 months, and also maintain continuous MMR until the 24 month timepoint. [ Time Frame: 24 months ]

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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. Patients with Ph+ CML who have failed treatment in the core protocol.
  4. Diagnosis of chronic myelogenous leukemia with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations (presence of BCR-ABL a review of a minimum 20 metaphases is required).
  5. Adequate end organ function as defined by:

    • Total bilirubin < 1.5 x ULN,
    • SGOT and SGPT < 2.5 x ULN,
    • Creatinine < 1.5 x ULN,
    • Serum amylase and lipase ≤ 1.5 x ULN,
    • Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related.
  6. Patients must have the following laboratory values (≥ LLN (lower limit of normal) or corrected to within normal limits with supplements prior to the first dose of study medication.):

    • Potassium ≥ LLN,
    • Magnesium ≥ LLN,
    • Phosphorus ≥ LLN,
    • Total calcium (corrected for serum albumin) ≥ LLN.

Exclusion criteria:

  1. Previously documented T315I mutations.
  2. Impaired cardiac function including any one of the following:

    • LVEF < 45% or below the institutional lower limit of the normal range (whichever is higher) as determined by locally read echocardiogram.
    • Inability to determine the QT interval on ECG.
    • Complete left bundle branch block.
    • Use of a ventricular-paced pacemaker.
    • Congenital long QT syndrome or a known family history of long QT syndrome.
    • History of or presence of clinically significant ventricular or atrial tachyarrhythmias.

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): NCT00718263

Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals +41613241111

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Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00718263     History of Changes
Other Study ID Numbers: CAMN107A2303E1
First Posted: July 18, 2008    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
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