A Study of Dasatinib vs. High-Dose Imatinib (600 mg) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML) Who Failed to Achieve Complete Cytogenetic Response After 3-18 Months of Imatinib Therapy

This study has been terminated.
(Insufficient Enrollment)
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00362466
First received: August 9, 2006
Last updated: November 18, 2009
Last verified: November 2009
  Purpose

The purpose of this clinical research study is to compare the rate of complete cytogenetic response of dasatinib to imatinib therapy at 6 months after randomization in chronic phase CML patients. The safety of this treatment will also be studied.


Condition Intervention Phase
Leukemia
Drug: Dasatinib
Drug: Imatinib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Randomized Phase III Study of Dasatinib vs. High-Dose (600 mg) Imatinib Mesylate in the Treatment of Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Are Imatinib Failures or Who Have Had a Suboptimal Response After 3-18 Months of Therapy With 400 mg Imatinib

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Complete Cytogenetic Response (CCyR) Rate at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major Molecular Response (MMR) Rates [ Time Frame: Month 3, Month 6, Month 12, Month 24 and Month 36 ] [ Designated as safety issue: No ]
  • CCyR Rates [ Time Frame: Month 3, Month 12, Month 24 and Month 36 ] [ Designated as safety issue: No ]
  • Estimate Time to MMR and CCyR [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) [ Time Frame: at 36 months ] [ Designated as safety issue: No ]
  • Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs [ Time Frame: From 2 weeks prior to randomization through Month 36. At least every 4 weeks until all study-related toxicities resolve to baseline, stabilize, or are deemed irreversible. ] [ Designated as safety issue: Yes ]
  • Duration of CCyR and MMR [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Best MMR Rates [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: April 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
50-180 mg once daily (QD)
Drug: Dasatinib
Tablets, Oral, Once daily, 5-7 years
Other Name: Sprycel®
Active Comparator: B
200-800 mg QD
Drug: Imatinib
Tablets, Oral, Once daily, 5-7 years

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women ≥18 years diagnosed with Chronic Phase Philadelphia chromosome positive (CP Ph+) CML who have failed to achieve CCyR after 3-18 months of therapy with imatinib 400 mg
  • Treatment initiation with imatinib 400 mg within 6 months of initial CML diagnosis
  • Able to tolerate chronic administration of imatinib at the highest dose (400-600 mg) the subject has received in the past
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2
  • Adequate hepatic and renal function

Exclusion Criteria:

  • Eligible and willing to undergo immediate autologous/allogeneic stem cell transplant
  • Previous diagnosis of accelerated/blast crisis CML
  • Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases
  • Previous documentation of T315I mutation
  • Uncontrolled or significant cardiovascular disease
  • Serious uncontrolled medical disorder/active infection
  • History of significant bleeding disorder unrelated to CML
  • Intolerance to imatinib ≥400 mg
  • Concurrent malignancies other than CML
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362466

  Hide Study Locations
Locations
United States, Alabama
Dr. Marshall Schreeder
Huntsville, Alabama, United States, 35805
United States, Arkansas
Local Institution
Little Rock, Arkansas, United States, 72205
United States, California
Local Institution
Alhambra, California, United States, 91801
Local Institution
Anaheim, California, United States, 92801
Local Institution
Beverly Hills, California, United States, 90211
Local Institution
Fullerton, California, United States, 92835
Local Institution
La Jolla, California, United States, 92093
Local Institution
La Verne, California, United States, 91750
Local Institution
Long Beach, California, United States, 90813
Local Institution
Los Angeles, California, United States, 90095
Local Institution
Los Angeles, California, United States, 90048
Local Institution
Los Angeles, California, United States, 90033
Local Institution
Northridge, California, United States, 91325
Local Institution
Oxnard, California, United States, 93030
Local Institution
Redondo Beach, California, United States, 90277
Local Institution
San Francisco, California, United States, 94143
Local Institution
Santa Maria, California, United States, 93454
Local Institution
Stanford, California, United States, 94305
United States, Colorado
Local Institution
Aurora, Colorado, United States, 80045
United States, Florida
Local Institution
Jacksonville, Florida, United States, 32207
Local Institution
Jacksonville, Florida, United States, 32209
M.D. Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
Local Institution
Pembroke Pines, Florida, United States, 33028
United States, Illinois
Local Institution
Chicago, Illinois, United States, 60637
United States, Indiana
Local Institution
Indianapolis, Indiana, United States, 46202
United States, Kansas
Local Institution
Kansas City, Kansas, United States, 66160
United States, Kentucky
Local Institution
Hazard, Kentucky, United States, 41701
United States, Michigan
Local Institution
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Local Institution
Rochester, Minnesota, United States, 55905
United States, Missouri
Local Institution
St. Louis, Missouri, United States, 63110
United States, Nebraska
Local Institution
Omaha, Nebraska, United States, 68114
United States, Nevada
Local Institution
Las Vegas, Nevada, United States, 89135
United States, New Jersey
Local Institution
Hackensack, New Jersey, United States, 07601
United States, New York
Local Institution
Buffalo, New York, United States, 14263
New York Presbyterian Hospital
New York, New York, United States, 10021
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
Local Institution
Durham, North Carolina, United States, 27710
United States, Ohio
Local Institution
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Local Institution
Oklahoma City, Oklahoma, United States, 73112
Local Institution
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Local Institution
Baltimore, Pennsylvania, United States, 21229
Local Institution
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Santee Hematology/Oncology
Sumter, South Carolina, United States, 29150
United States, Texas
Local Institution
Dallas, Texas, United States, 75390
Local Institution
Houston, Texas, United States, 77030
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00362466     History of Changes
Other Study ID Numbers: CA180-044
Study First Received: August 9, 2006
Results First Received: July 24, 2009
Last Updated: November 18, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Leukemia (chronic myeloid leukemia - chronic phase)

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Imatinib
Dasatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014