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Status:

COMPLETED

Nilotinib in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

Lead Sponsor:

Cancer Trials Ireland

Conditions:

Leukemia

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

Brief Summary

RATIONALE: Nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well nilotinib works in treating patients...

Detailed Description

OBJECTIVES: Primary * To establish the complete cytogenetic response rate at 6 months in patients with newly diagnosed Philadelphia chromosome-positive chronic phase chronic myelogenous leukemia tre...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Cytogenetically confirmed chronic myelogenous leukemia (CML) by standard conventional cytogenetic analysis of bone marrow\*
  • Newly diagnosed disease (within the past 6 months) NOTE: \*FISH cannot be used
  • In chronic phase, as defined by the following:
  • Less than 15% blasts in peripheral blood and bone marrow
  • Less than 30% blasts plus promyelocytes in peripheral blood and bone marrow
  • Less than 20% basophils in peripheral blood
  • Platelet count ≥ 100,000/mm\^3
  • No evidence of extramedullary leukemic involvement, except for hepatosplenomegaly
  • Philadelphia chromosome-positive disease as demonstrated by (9;22) translocation (presence of Bcr-Abl)
  • A review of ≥ 20 metaphases is required
  • No previously documented T315I mutations
  • PATIENT CHARACTERISTICS:
  • ECOG performance status 0-2
  • Total bilirubin \< 1.5 times upper limit of normal (ULN)
  • AST and ALT \< 2.5 times ULN
  • Estimated glomerular filtration rate ≥ 30 mL/min
  • Serum amylase and lipase ≤ 1.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN (unless related to CML)
  • Potassium ≥ lower limit of normal (LLN)
  • Magnesium ≥ LLN
  • Phosphorous ≥ LLN
  • Total calcium ≥ LLN (corrected for serum albumin)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No impaired cardiac function including, but not limited to, any of the following:
  • LVEF \< 45% or \< LLN by ECHO
  • Inability to determine the QT interval on ECG
  • Complete left bundle branch block
  • Congenital long QT syndrome or a known family history of long QT syndrome
  • History of or presence of clinically significant ventricular or atrial tachyarrhythmias
  • Clinically significant resting bradycardia (\< 50 beats/min)
  • QTc \> 450 msec on an average of 3 serial baseline ECGs (using the QTcF formula)
  • Clinically documented myocardial infraction within the past 12 months
  • Unstable angina within the past 12 months
  • Other clinically significant heart disease (e.g., congestive heart failure or uncontrolled hypertension)
  • No severe or uncontrolled medical condition (e.g., uncontrolled diabetes or active or uncontrolled infection)
  • No history of significant congenital or acquired bleeding disorder unrelated to CML
  • No history of non-compliance to medical regimens
  • No other primary malignancy unless it is neither currently clinically significant nor requiring active intervention
  • No impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery)
  • No acute pancreatitis within the past year
  • No history of chronic pancreatitis
  • No acute or chronic liver, pancreatic, or severe renal disease considered unrelated to CML
  • PRIOR CONCURRENT THERAPY:
  • No prior therapy for CML other than hydroxyurea and/or anagrelide
  • Prior imatinib mesylate allowed provided it was administered for ≤ 14 days
  • More than 30 days since prior and no other concurrent investigational agents
  • More than 4 weeks since prior major surgery and recovered
  • No other concurrent anticancer agents, including chemotherapy and biologic agents
  • No concurrent strong CYP3A4 inhibitors (e.g., erythromycin, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil)
  • No concurrent strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St. John's wort)
  • No concurrent medications that have the potential to prolong QT interval
  • No concurrent grapefruit, star fruit, Seville oranges, or their derivatives

Exclusion

    Key Trial Info

    Start Date :

    October 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    February 1 2016

    Estimated Enrollment :

    40 Patients enrolled

    Trial Details

    Trial ID

    NCT00809211

    Start Date

    October 1 2008

    End Date

    February 1 2016

    Last Update

    July 24 2018

    Active Locations (6)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (6 locations)

    1

    University of Texas Health Science Center at San Antonio

    San Antonio, Texas, United States, 78229-3900

    2

    Universitätsklinikum Charité Berlin

    Berlin, Germany

    3

    Belfast City Hospital

    Belfast, Ireland

    4

    St. James's Hospital

    Dublin, Ireland, 8