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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00718263
First received: June 3, 2008
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Myelogenous Leukemia, Chronic
Drug: Nilotinib
Drug: Imatinib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: April 2008
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nilotinib Drug: Nilotinib
Active Comparator: imatinib Drug: Imatinib

  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. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718263

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 198 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00718263     History of Changes
Other Study ID Numbers: CAMN107A2303E1
Study First Received: June 3, 2008
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 29, 2014