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A Randomized Open-label Study of 400 mg Versus 800 mg of Imatinib Mesylate in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Using Molecular Endpoints.


Phase 3
18 Years
75 Years
Not Enrolling
Both
Leukemia, Myeloid, Chronic Phase

Thank you

Trial Information

A Randomized Open-label Study of 400 mg Versus 800 mg of Imatinib Mesylate in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Using Molecular Endpoints.


Inclusion Criteria:



- Patients within 6 months of diagnosis (date of initial diagnosis is the date of first
cytogenetic analysis)

- Diagnosis of chronic myelogenous leukemia (CML) in chronic phase with cytogenetic
confirmation of Philadelphia chromosome of (9;22) translocations and presence of
Breakpoint cluster region gene-abelson proto-oncogene (Bcr-Abl)

- Documented chronic phase CML

- Adequate end organ function as defined by:

- total bilirubin < 1.5 x Upper Limit of Normal (ULN)

- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate
transaminase (SGPT) < 2.5 x ULN

- creatinine < 1.5 x ULN

Exclusion Criteria:

- Patients in late chronic phase, accelerated phase, or blastic phase are excluded

- Patients who have received other investigational agents

- Patients who received Gleevec/Glivec for any duration prior to study entry, with the
exception of those patients successfully completing [CSTI571A2107 (NCT00428909)]
study immediately prior to the participation in this study

- Patient received any treatment for CML prior to study entry for longer than 2 weeks
with the exception of hydroxyurea and/or anagrelide

- Patients with another primary malignancy except if the other primary malignancy is
neither currently clinically significant or requiring active intervention

- Patients who are: (a) pregnant, (b) breast feeding, (c) of childbearing potential
without a negative pregnancy test prior to baseline and (d) male or female of
childbearing potential unwilling to use barrier contraceptive precautions throughout
the trial (post-menopausal women must be amenorrheic for at least 12 months to be
considered of non-childbearing potential).

- Patient with a severe or uncontrolled medical condition (i.e., uncontrolled
diabetes,chronic renal disease)

- Patient previously received radiotherapy to ≥ 25% of the bone marrow

- Patient had major surgery within 4 weeks prior to study entry, or who have not
recovered from prior major surgery

- Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status Score ≥
3

- Patients with International normalized ratio (INR) or partial thromboplastin time
(PTT) > 1.5 x ULN, with the exception of patients on treatment with oral
anticoagulants

- Patients with known positivity for human immunodeficiency virus (HIV); baseline
testing for HIV is not required

- Patients with identified sibling donors where allogeneic bone marrow transplant is
elected as first line treatment

Other protocol-defined inclusion/exclusion criteria applied.

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:

Percentage of Participants With Major Molecular Response (MMR) Rates at 12 Months

Outcome Description:

MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally).

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:

CSTI571K2301

NCT ID:

NCT00124748

Start Date:

June 2005

Completion Date:

November 2010

Related Keywords:

  • Leukemia, Myeloid, Chronic Phase
  • CML
  • Philadelphia positive
  • Bcr-abl
  • imatinib mesylate
  • Chronic myeloid leukemia (CML) in chronic phase
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Cleveland Clinic FoundationCleveland, Ohio  44195
Roswell Park Cancer InstituteBuffalo, New York  14263
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Rush University Medical CenterChicago, Illinois  60612-3824
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Hackensack University Medical CenterHackensack, New Jersey  07601
Rocky Mountain Cancer CenterDenver, Colorado  80218
Cancer Center at Hackensack University Medical CenterHackensack, New Jersey  07601
Cancer Centers of the CarolinasGreenville, South Carolina  29605
University of MinnesotaMinneapolis, Minnesota  55455
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
Duke University Medical CenterDurham, North Carolina  27710
Indiana Blood and Marrow TransplantBeech Grove, Indiana  46107
UCLA Medical CenterLos Angeles, California  90095-7059
University of KentuckyLexington, Kentucky  40536-0098
Hematology and Oncology SpecialistsNew Orleans, Louisiana  70115
San Juan Oncology AssociatesFarmington, New Mexico  87401
Cancer Center of the CarolinasGreenville, South Carolina  29615
The Jones ClinicGermantown, Tennessee  38138
Kaiser Permanente Northwest RegionPortland, Oregon  97227
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
Sarah Cannon Research InstituteNashville, Tennessee  37203
University of South AlabamaMobile, Alabama  36693
University of MiamiBerkeley, California  94704
Alta Bates Comprehsenive Cancer CenterBerkeley, California  94704
South Bay Oncology Hematology PartnersCampbell, California  95008
Osler Medical Inc.Melbourne, Florida  32901
Advanced Medical SpecialistsMiami, Florida  33176
Hematology-Oncology Associates, P.A.Pensacola, Florida  32501
Indiana Blood and Marrow InstitutwBeech Grove, Indiana  46107
University of Iowa Hospitals & ClinicIowa City, Iowa  52242
University of Kentucky - C201 ClinicLexington, Kentucky  40536
Lousville Oncology, Clinical Research Program M-25Louisville, Kentucky  40202
Jayne S. Gurtler, MD, Laura A. Brinz, MD & Angelo Russo, MDMetairie, Louisiana  70006
LSU Health Scine CenterShreveport, Louisiana  71130
LSU Health Science CenterShreveport, Louisiana  71103
St. Agnes HospitalBaltimore, Maryland  21229
Great Lakes Cancer InstituteLansing, Michigan  48910
U of MinnesotaMinneapolis, Minnesota  55455
Cancer Center of the CarolinasGreenville, North Carolina  29615
University Hospitals of Cleveland, Case Comprehensive Cancer CenterCleveland, Ohio  44106
Kaiser Permanente Northwest Region Oncology/HemacologyPortland, Oregon  97227
University of Pittsburg, Hillman Cancer CenterPittsburgh, Pennsylvania  15232
MUSC Hollings Cancer CenterCharleston, South Carolina  29425
UT Southwestern Harold C. Simmons Comprehensive Cancer CenterDallas, Texas  75390
University of Texas / MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Virgina Cancer Center, UVA Division of Hematology & OncologyCharlottesville, Virginia  22908