Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Nilotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Lead Sponsor:

Asan Medical Center

Conditions:

Leukemia

Eligibility:

All Genders

15+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, e...

Detailed Description

OBJECTIVES: Primary * To determine the clinical efficacy of nilotinib and combination chemotherapy, in terms of hematologic and molecular complete remission (CR) rates, in patients with newly diagno...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Newly diagnosed acute lymphoblastic leukemia or acute mixed lineage leukemia
  • Positive for Bcr-Abl fusion transcript (Philadelphia chromosome-positive disease) by RT-PCR
  • PATIENT CHARACTERISTICS:
  • ECOG performance status 0-2
  • Total bilirubin \< 2 mg/dL
  • SGOT \< 3 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN (unless considered tumor-related)
  • Creatinine \< 2.0 mg/dL ULN
  • Serum amylase and lipase ≤ 1.5 times ULN
  • Potassium, magnesium, and phosphorus normal (supplementation allowed)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No rare hereditary problems with galactose intolerance, severe lactase deficiency, or glucose-galactose malabsorption
  • No known sensitivity to any of the study drugs
  • No severe medical condition that, in the opinion of the investigator, would preclude study participation
  • No impaired cardiac function, including any of the following:
  • LVEF \< 45% or below the lower limit of normal by ECHO
  • Long QT syndrome or known family history of long QT syndrome
  • Clinically significant resting bradycardia (\< 50 beats per minute)
  • QTc \> 450 msec on baseline ECG (using the QTcF formula)
  • Myocardial infarction within the past 12 months
  • Other clinically significant heart disease, including any of the following:
  • Unstable angina
  • Congestive heart failure
  • Uncontrolled hypertension
  • Uncontrolled arrhythmias
  • No other primary malignant disease requiring systemic treatment
  • No acute or chronic liver, pancreatic, or severe renal disease
  • No other severe and/or life-threatening medical disease
  • No history of significant congenital or acquired bleeding disorder unrelated to cancer
  • No impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug
  • No history of non-compliance
  • PRIOR CONCURRENT THERAPY:
  • More than 30 days since prior investigational agents
  • No concurrent medications that have the potential to prolong the QTc interval
  • No concurrent strong CYP3A4 inhibitors
  • No concurrent therapeutic coumarin derivatives

Exclusion

    Key Trial Info

    Start Date :

    January 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2014

    Estimated Enrollment :

    91 Patients enrolled

    Trial Details

    Trial ID

    NCT00844298

    Start Date

    January 1 2009

    End Date

    July 1 2014

    Last Update

    September 7 2015

    Active Locations (16)

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

    Page 1 of 4 (16 locations)

    1

    Daegu Fatima Hospital

    Daegu, South Korea, 701-600

    2

    Kyungpook National University Hospital

    Daegu, South Korea, 702-701

    3

    Yeungnam University Medical Center

    Daegu, South Korea, 712-749

    4

    Daegu Catholic University Hospital

    Daegu, South Korea