Know Cancer

or
forgot password

An Exploratory Trial to Assess the Improvement of Chronic Low-grade Non-hematologic Adverse Events Experienced by Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Treated With Imatinib When Switched to Nilotinib Treatment


Phase 4
18 Years
N/A
Not Enrolling
Both
Chronic Myelogenous Leukemia

Thank you

Trial Information

An Exploratory Trial to Assess the Improvement of Chronic Low-grade Non-hematologic Adverse Events Experienced by Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Treated With Imatinib When Switched to Nilotinib Treatment


Inclusion Criteria:



1. Male or female patients ≥ 18 years of age

2. ECOG 0, 1, or 2

3. Diagnosis of CML-CP associated with Bcr-Abl quantifiable by RQ-PCR (IS)

4. Patients must be an imatinib responder and achieved the following efficacy milestones
as appropriate for the length of time on imatinib therapy as per protocol

5. CML-CP patients initiated on any dose of imatinib

6. Ability to provide written informed consent prior to any study related screening
procedures being done

Exclusion Criteria:

1. Loss of CHR or cytogenetic response

2. Prior accelerated phase or blast phase CML

3. Previously documented T315I mutation

4. Presence of chromosomal abnormalities (trisomy 8) and/or clonal evolution other than
Ph+.

5. Previous treatment with any other tyrosine kinase inhibitor except for imatinib.

6. Treatment with other investigational agents within 30 days of Day 1.

7. History of non-compliance to medical regimens or inability to grant consent.

8. Women who are pregnant, breast feeding, or of childbearing potential without a
negative serum test at baseline. Male or female patients of childbearing potential
unwilling to use contraceptive precautions throughout the trial and 3 months
following discontinuation of study drug. Post-menopausal women must be amenorrheic
for at least 12 months to be considered of non-childbearing potential. Women of
childbearing potential must have a negative serum pregnancy test prior to the first
dose of nilotinib.

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Improvement of (CTCAE grading scale) of imatinib related chronic low grade non hematologic Adverse Event after switch to treatment with nilotinib at End of Cycle 3

Outcome Time Frame:

3 months

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CAMN107AUS17

NCT ID:

NCT00980018

Start Date:

December 2009

Completion Date:

December 2012

Related Keywords:

  • Chronic Myelogenous Leukemia
  • CML
  • Leukemia
  • Tasigna
  • nilotinib
  • AMN107
  • CML-CP
  • Chronic Phase
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome

Name

Location

Texas Oncology, P.A.Dallas, Texas  75246
Highlands Oncology GroupSpringdale, Arkansas  72764
Oregon Health Sciences UniversityPortland, Oregon  
Florida Cancer InstituteNew Port Richey, Florida  34652
The Jones ClinicGermantown, Tennessee  38138
MD Anderson Cancer Center/University of TexasHouston, Texas  77030
St. Agnes HospitalBaltimore, Maryland  21229
St. Louis University Cancer CenterSt. Louis, Missouri  63110
USC Norris Cancer Center LAC & USC Medical CenterLos Angeles, California  90033
Southwest Cancer Care MurrietaPoway, California  92064
Rocky Mountain Cancer Centers RMCC - AuroraGreenwood Village, Colorado  
Cancer Centers of Florida PA Cancer Centers of FL-Orlando-4Ocoee, Florida  *see dep*
Stroger Cook County Hospital John H. Stroger HospitalChicago, Illinois  60612
St. Francis Hospital and Health Centers IndianaBlood&MarrowTransplantnBeech Grove, Indiana  46107
Northwest Cancer Specialists Salmon Creek OfficePortland, Oregon  97210
Texas Oncology, P.A. Texas Oncology - Sugar LandDallas, Texas  75246
Presbyterian Hospital of Dallas TexasOncology@PresbyterianHospDallas, Texas  75231
Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)San Antonio, Texas  78229
Hematology Oncology Services of Arkansas SCLittle Rock, Arkansas  72205