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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
Link to the ClinicalTrials.gov recordInformation obtained from ClinicalTrials.gov on February 23, 2012
Title of trial/grant titleA 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
Current status of trialTerminated
Sponsors and collaboratorsBristol-Myers Squibb
Information provided byBristol-Myers Squibb
ClinicalTrials.gov identifierNCT00362466
PurposeThe 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(s)Leukemia
Intervention(s)Drug: Dasatinib
Drug: Imatinib
PhasePhase III
Study type and designAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Official titleAn 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
Primary outcomeComplete Cytogenetic Response (CCyR) Rate at Month 6 Month 6 No
Secondary outcomeMajor Molecular Response (MMR) Rates Month 3, Month 6, Month 12, Month 24 and Month 36 No
CCyR Rates Month 3, Month 12, Month 24 and Month 36 No
Estimate Time to MMR and CCyR throughout the study No
Progression Free Survival (PFS) at 36 months No
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs 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. Yes
Duration of CCyR and MMR Throughout the study No
Best MMR Rates throughout study No
Study startApril 2007
Minimum age18 Years
Maximum ageN/A
GenderBoth
Eligibility criteriaInclusion Criteria:

- Men and women â¿¥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 â¿¥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 â¿¥400 mg

- Concurrent malignancies other than CML
Study chairs or principal investigatorsBristol-Myers Squibb, Study Director, Bristol-Myers Squibb
LocationsAlabama, United States

Dr. Marshall Schreeder
Huntsville
Alabama
35805

Arkansas, United States

Local Institution
Little Rock
Arkansas
72205

California, United States

Local Institution
Alhambra
California
91801

California, United States

Local Institution
Anaheim
California
92801

California, United States

Local Institution
Beverly Hills
California
90211

California, United States

Local Institution
Fullerton
California
92835

California, United States

Local Institution
La Jolla
California
92093

California, United States

Local Institution
La Verne
California
91750

California, United States

Local Institution
Long Beach
California
90813

California, United States

Local Institution
Los Angeles
California
90095

California, United States

Local Institution
Los Angeles
California
90048

California, United States

Local Institution
Los Angeles
California
90033

California, United States

Local Institution
Northridge
California
91325

California, United States

Local Institution
Oxnard
California
93030

California, United States

Local Institution
Redondo Beach
California
90277

California, United States

Local Institution
San Francisco
California
94143

California, United States

Local Institution
Santa Maria
California
93454

California, United States

Local Institution
Stanford
California
94305

Colorado, United States

Local Institution
Aurora
Colorado
80045

Florida, United States

Local Institution
Jacksonville
Florida
32207

Florida, United States

Local Institution
Jacksonville
Florida
32209

Florida, United States

M.D. Anderson Cancer Center Orlando
Orlando
Florida
32806

Florida, United States

Local Institution
Pembroke Pines
Florida
33028

Illinois, United States

Local Institution
Chicago
Illinois
60637

Indiana, United States

Local Institution
Indianapolis
Indiana
46202

Kansas, United States

Local Institution
Kansas City
Kansas
66160

Kentucky, United States

Local Institution
Hazard
Kentucky
41701

Michigan, United States

Local Institution
Ann Arbor
Michigan
48109

Minnesota, United States

Local Institution
Rochester
Minnesota
55905

Missouri, United States

Local Institution
St. Louis
Missouri
63110

Nebraska, United States

Local Institution
Omaha
Nebraska
68114

Nevada, United States

Local Institution
Las Vegas
Nevada
89135

New Jersey, United States

Local Institution
Hackensack
New Jersey
07601

New York, United States

Local Institution
Buffalo
New York
14263

New York, United States

New York Presbyterian Hospital
New York
New York
10021

New York, United States

New York Medical College
Valhalla
New York
10595

North Carolina, United States

Local Institution
Durham
North Carolina
27710

Ohio, United States

Local Institution
Cleveland
Ohio
44195

Oklahoma, United States

Local Institution
Oklahoma City
Oklahoma
73112

Oklahoma, United States

Local Institution
Tulsa
Oklahoma
74136

Pennsylvania, United States

Local Institution
Baltimore
Pennsylvania
21229

Pennsylvania, United States

Local Institution
Pittsburgh
Pennsylvania
15232

South Carolina, United States

Santee Hematology/Oncology
Sumter
South Carolina
29150

Texas, United States

Local Institution
Dallas
Texas
75390

Texas, United States

Local Institution
Houston
Texas
77030
LinksBMS Clinical Trials Disclosure
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Study ID numbersCA180-044
Last updatedNovember 18, 2009
Record first receivedAugust 9, 2006
ClinicalTrials.gov identifierNCT00362466
Download dateInformation obtained from ClinicalTrials.gov on February 23, 2012
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