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A Phase III Randomized, Open- Label Multi-center Study of Nilotinib Versus Imatinib in Adult Patients With Ph+ Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have a Suboptimal Cytogenetic Response (CyR) on Imatinib


Phase 3
18 Years
N/A
Not Enrolling
Both
Myelogenous Leukemia

Thank you

Trial Information

A Phase III Randomized, Open- Label Multi-center Study of Nilotinib Versus Imatinib in Adult Patients With Ph+ Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have a Suboptimal Cytogenetic Response (CyR) on Imatinib


This trial was to evaluate the CCyR rate at 12 months of nilotinib therapy when compared to
imatinib treatment in patients with suboptimal response to imatinib. The patients were
stratified by prior duration of initial imatinib treatment, and were randomized to receive
either 400 mg/twice daily of continuous nilotinib or imatinib treatment. The first stratum
patients were treated with imatinib = 6 to < 12 months and having at least a minimal
cytogenetic, but no partial cytogenetic response; and the second stratum patients were
treated with imatinib = 12 months to < 18 months and having partial cytogenetic response
(PCyR), but no CCyR.

Inclusion Criteria


Inclusion criteria:

Diagnosis of Philadelphia chromosome positive chronic myelogenous leukemia in the chronic
phase.

Patients with suboptimal cytogenetic response to a dose of 400 mg imatinib (first line
therapy) defined as:

- 6 to < 12 months of treatment and -have 36 - 95% Ph+ metaphases, or

- 12 to <18 months of treatment and have 1 - 35% Ph+ metaphases (Standard cytogenetics,
no FISH [fluorescence in situ hybridization] analysis was allowed).

Exclusion criteria:

- Patient who have received more than 18 months of imatinib therapy

- Patients who have achieved partial or complete cytogenetic response and lost that
response prior to entering the study.

- Prior treatment with greater than 400 mg/day imatinib.

- Uncontrolled or significant cardiovascular disease.

- Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or
uncontrolled infection).

- Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol,
phenprocoumon)

- Currently taking certain medications that could affect the rhythm of your heart.

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete Cytogenetic Response Rate(CCyR) in Patients Who Had a Suboptimal Cytogenetic Response on Imatinib

Outcome Description:

Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CAMN107A2302

NCT ID:

NCT00519090

Start Date:

October 2007

Completion Date:

October 2008

Related Keywords:

  • Myelogenous Leukemia
  • leukemia
  • bone marrow
  • leukemia symptoms
  • cml
  • complete blood count
  • lymphocyte
  • blood cancer
  • leukocytes
  • chronic leukemia
  • bone marrow biopsy
  • leukemia research
  • leukemia cells
  • bone marrow disease
  • chronic myeloid leukemia
  • blood cancer symptoms
  • white blood cell diseases
  • chronic myelogenous leukemia
  • leukemia treatment
  • leukemia facts
  • leucemia
  • facts about leukemia
  • myelogenous leukemia
  • newly diagnosed CML
  • suboptimal response
  • Philadelphia chromosome positive (Ph+)
  • chronic myelogenous leukemia in chronic phase (CML-CP)
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
University of MichiganAnn Arbor, Michigan  48109-0624
Northwestern Memorial HospitalChicago, Illinois  60611
Swedish Cancer InstituteSeattle, Washington  98104
Southern California Permanente Medical GroupDowney, California  90242
Rocky Mountain Cancer CenterDenver, Colorado  80218
Kaiser Permanente Medical GroupLos Angeles, California  90027
Indiana Blood and Marrow TransplantationIndianapolis, Indiana  46202
Vanderbilt UniversityNashville, Tennessee  37232-6305
Oregon Health Sciences UniversityPortland, Oregon  
The University of Chicago Medical CenterChicago, Illinois  60637-1470
St. Luke's Hospital and Health NetworkBethlehem, Pennsylvania  18015
Methodist Cancer CenterOmaha, Nebraska  68114
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
The Cancer Center at Hackensack University Medical CenterHackensack, New Jersey  07601
Johns Hopkins HospitalBaltimore, Maryland  21287
Duke University HospitalDurham, North Carolina  27710
University of Texas/MD Anderson Cancer CenterHouston, Texas  77030
Kaiser Permanente Medical Group/Hayward Medical CenterHayward, California  94540
Kaiser Permanente Medical Group/Oakland Medical CenterOakland, California  94601
Kaiser Permanente Medical Group/South San Francisco Medical CenterS. San Francisco, California  94101
Kaiser Permanente Medical Group/Sacramento Medical CenterSacramento, California  94203
Kaiser Permanente Medical Group/Santa Clara Medical OfficeSanta Clara, California  95050
Kaiser Permanente Medical Group/Vallejo Medical CenterVallejo, California  94589
Kaiser Permanente Medical Group/Walnut Creek Medical CenterWalnut Creek, California  94595
Southen California Permanente Medical GroupWoodland Hills, California  91364
Holden Cancer CenterIowa City, Iowa  52240
Hematology Centers of Western MichiganGrand Rapids, Michigan  49501
Jones Cancer CenterGermantown, Tennessee  38138