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Status:

COMPLETED

Nilotinib and Imatinib Mesylate in Treating Patients With Early Chronic Phase Chronic Myelogenous Leukemia

Lead Sponsor:

Gruppo Italiano Malattie EMatologiche dell'Adulto

Conditions:

Leukemia

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

Brief Summary

RATIONALE: Nilotinib and imatinib mesylate 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 giving nilotin...

Detailed Description

OBJECTIVES: Primary * To assess the complete cytogenetic response rate at 12 months in patients with Philadelphia chromosome- and BCR-ABL-positive early chronic phase chronic myelogenous leukemia tr...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Cytologically and cytogenetically confirmed chronic myelogenous leukemia meeting the following criteria:
  • Early chronic phase disease (\< 6 months from diagnosis)
  • Philadelphia chromosome-positive disease
  • BCR-ABL-positive
  • PATIENT CHARACTERISTICS:
  • WHO performance status 0-1
  • ALT and AST = 2.5 times upper limit of normal (ULN) (5.0 times ULN if considered due to leukemia)
  • Alkaline phosphatase = 2.5 times ULN (unless considered due to leukemia)
  • Serum bilirubin = 1.5 times ULN
  • Serum creatinine = 1.5 times ULN
  • Serum amylase = 1.5 times ULN
  • Serum lipase = 1.5 times ULN
  • Normal serum levels of the following or correctable with supplements:
  • Potassium
  • Total calcium (corrected for serum albumin)
  • Magnesium
  • Phosphorus
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier method contraception during study and for up to 3 months following completion of study treatment
  • No impaired cardiac function, including any of the following:
  • LVEF \< 45% by MUGA scan or echocardiogram
  • Uncontrolled congestive heart failure
  • Uncontrolled hypertension
  • Uncontrolled angina pectoris
  • Myocardial infarction within the past 12 months
  • No significant electric heart abnormalities, including any of the following:
  • History or active ventricular or atrial tachyarrhythmias
  • Congenital long QT syndrome and/or QTc \> 450 msec on screening ECG
  • No history of acute (within one year) or chronic pancreatitis
  • No impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
  • No acute or chronic liver or renal disease considered unrelated to leukemia
  • No known diagnosis of HIV infection
  • No other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
  • No other primary malignancy that is currently clinically significant or requires active intervention
  • PRIOR CONCURRENT THERAPY:
  • More than 2 weeks since prior major surgery and recovered
  • More than 30 days since prior imatinib mesylate, with a washout period of ≥ 7 days
  • More than 4 weeks since prior investigational drug
  • No prior hematopoietic stem cell transplantation
  • No concurrent therapeutic coumarin derivates (i.e., warfarin, acenocoumarol, phenprocoumon)
  • No concurrent medications that would prolong the QT interval
  • No concurrent chemotherapy, investigational agents, radiotherapy, or biologic therapy
  • Prior treatment with hydroxyurea or anagrelide allowed

Exclusion

    Key Trial Info

    Start Date :

    February 9 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 10 2014

    Estimated Enrollment :

    129 Patients enrolled

    Trial Details

    Trial ID

    NCT00769327

    Start Date

    February 9 2009

    End Date

    October 10 2014

    Last Update

    January 4 2022

    Active Locations (37)

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    Page 1 of 10 (37 locations)

    1

    Centro Oncologico Basilicata

    Rionero in Vulture, Potenza, Italy

    2

    Ospedale Civile Alessandria

    Alessandria, Italy, I-15100

    3

    Dipartimento Area Medica P.O.

    Ascoli Piceno, Italy, 63100

    4

    S.G. Moscati Hospital

    Avellino, Italy, 83100