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Study of Dasatinib in Patients With Chronic Phase Chronic Myeloid Leukemia and a Suboptimal Response to Imatinib
Link to the ClinicalTrials.gov recordInformation obtained from ClinicalTrials.gov on February 23, 2012
Title of trial/grant titleStudy of Dasatinib in Patients With Chronic Phase Chronic Myeloid Leukemia and a Suboptimal Response to Imatinib
Current status of trialTerminated
Sponsors and collaboratorsBristol-Myers Squibb
Information provided byBristol-Myers Squibb
ClinicalTrials.gov identifierNCT00320190
PurposeThe purpose of this study is to compare the efficacy of dasatinib with that of high-dose
(800-mg) imatinib in participants with chronic phase chronic myeloid leukemia who achieved
only a suboptimal response after at least 3 months of monotherapy with 400-mg imatinib. The
safety of these treatments will also be evaluated.
Condition(s)Leukemia, Myeloid, Chronic
Intervention(s)Drug: Imatinib
Drug: Dasatinib
PhasePhase II
Study type and designAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Official titleAn Open-label, Randomized Study of Dasatinib vs High-dose (800-mg) Imatinib in the Treatment of Subjects With Chronic Phase Chronic Myeloid Leukemia Who Have Had a Suboptimal Response After at Least 3 Months of Therapy With 400 mg Imatinib
Further study detailsParticipants were randomized 2:1 to dasatinib or high-dose imatinib, respectively.
Randomization was stratified by a suboptimal response, defined as a hematologic response
less than a complete hematologic response after at least 3 months of monotherapy with 400-mg
imatinib; a cytogenic response (CgR) less than a partial CgR (PCgR) after at least 6 months
of monotherapy with 400-mg; a PCgR after at least 12 months of monotherapy with 400-mg
imatinib; or less than a major molecular response with a complete CgR after at least 18
months of monotherapy with 400-mg imatinib.

Participants received either dasatinib or imatinib for 12 months or until disease
progression, unacceptable toxicity, consent withdrawal, or study discontinuation. After 12
months, who had a confirmed major molecular response and were still receiving dasatinib,
100 mg, or imatinib, 800 mg, were eligible to extend treatment for an additional 12 months.
Participants permanently discontinuing treatment before 12 months were considered treatment
failures and withdrawn from the study.
Primary outcomePercentage of Participants With Chronic Phase Chronic Myeloid Leukemia Who Have a Major Molecular Response (MMolR) At 12 months from baseline No MMolR is defined as reduction in transcript levels of the breakpoint cluster region (BCR)-V-abl Abelson murine leukemia viral oncogene homolog 1 (ABL) gene of at least 3 log. The BCR-ABL gene has a role in the production of a mutated protein that converts bone marrow stem cells from normal to leukemic.
Secondary outcomePercentage of Participants With Death as Outcome, Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, and AEs Leading to Discontinuation Months 1 to 12, continuously, and Months 12 to 24, continuously Yes AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. SAE=any untoward medical occurrence that at any dose results in death, persistent or significant disability/incapacity, drug dependency, or drug abuse; prolongs inpatient hospitalization; or is life-threatening, a congenital anomaly/birth defect, or an important medical event. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment.
Percentage of Participants With On-study AEs of Special Interest Months 1 to 12, continuously, and Months 12 to 24, continuously Yes GI=gastrointestinal. AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. Grade 1=mild; Grade 2=moderate; Grade 3=severe and undesirable; Grade 4=life-threatening or disabling; Grade 5=death. Percentages based on the number of participants with a specific grade at baseline. Participants without on-study test values for a particular laboratory analyte are not included in the reporting of that analyte.
Median Time to MMolR At 3, 6, 9, and 12 months from baseline No Time to MMolR is defined as the time from first treatment dose until measurement criteria are first met for MMolR. MMolR is defined as a reduction in transcript levels of the BCR-ABL gene of at least 3 log from baseline.
Percentage of Participants With Complete Cytogenetic Response At 6 and 12 months from baseline No Cytogenetic response is based on the prevalence of Ph+ metaphases among cells in metaphase in a bone marrow sample.
Median Time to Treatment Failure Randomization to disease progression, death, or discontinuation (to 12 months) No Time to treatment failure is defined as the time in days from randomization to progressive disease documented by the investigator, to death from any cause without prior progression, or to early treatment discontinuation for any reason, whichever occurs first. Participants without disease progression or who do not die and complete the 12-month study treatment are censored on the date of their last molecular, cytogenetic, or hematologic assessment.
Median Time to Progression-free Survival Randomization to disease progression or death (to 12 months) No Progression-free survival is defined as the time in days from randomization to progressive disease documented by the investigator or to death from any cause without prior progression. Participants without progressive disease or who do not die and complete the 12-month treatment are censored on the date of their last molecular, cytogenetic, or hematologic assessment.
Study startAugust 2006
Minimum age18 Years
Maximum ageN/A
GenderBoth
Eligibility criteriaInclusion Criteria:

- Chronic phase Ph^+ chronic myeloid leukemia (CML) demonstrating only a suboptimal
response, defined as a hematologic response that is less than a complete hematologic
response after at least 3 months of monotherapy with imatinib, 400 mg; a cytogenic
response (CgR) that is less than a partial CgR (PCgR) after at least 6 months of
monotherapy with imatinib, 400 mg; a PCgR after at least 12 months of monotherapy
with imatinib, 400 mg; or less than a major molecular response with a complete CgR
after at least 18 months of monotherapy with imatinib, 400 mg.

- Either gender

- Age of 18 years or older

Exclusion Criteria:

- Previous diagnosis of accelerated phase or blast crisis CML

- Uncontrolled or significant cardiovascular disease

- History of significant bleeding disorder unrelated to CML

- Concurrent malignancies

- Intolerance of imatinib, 400 mg

- Prior treatment with imatinib at a dose higher than 400 mg

- Prior stem cell transplantation and/or high-dose chemotherapy for CML
Study chairs or principal investigatorsBristol-Myers Squibb, Study Director, Bristol-Myers Squibb
LocationsBelgium

Local Institution
Antwerpen
2060

Belgium

Local Institution
Charleroi
6000

Finland

Local Institution
Helsinki
00029

Finland

Local Institution
Tampere
33380

France

Local Institution
Lyon Cedex 03
69437

France

Local Institution
Marseille Cedex 9
13273

France

Local Institution
Montpellier Cedex 5
34295

France

Local Institution
Paris Cedex 10
75475

France

Local Institution
Rennes
35033

France

Local Institution
Strasbourg Cedex
67091

France

Local Institution
Toulouse Cedex 09
31059

Germany

Local Institution
Leipzig
04103

Italy

Local Institution
Orbassano (To)
10043

Norway

Local Institution
Oslo
0027

Norway

Local Institution
Trondheim
7006

Portugal

Local Institution
Lisboa
1649-035

Russian Federation

Local Institution
Moscow
125167

Russian Federation

Local Institution
Saint-Petersburg
191024

Russian Federation

Local Institution
St.Petersburg
197022

Spain

Local Institution
Murcia
30008

Sweden

Local Institution
Lund
221 85

Sweden

Local Institution
Orebro
70185

Sweden

Local Institution
Uppsala
751 85

Central, United Kingdom

Local Institution
Glasgow
Central
G31 2ER

Greater London, United Kingdom

Local Institution
London
Greater London
W12 ONN

Greater London, United Kingdom

Local Institution
London
Greater London
SE5 9RS

North Yorkshire, United Kingdom

Local Institution
Leeds
North Yorkshire
LS9 7FT
LinksBMS Clinical Trials Disclosure
Investigator Inquiry form
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Study ID numbersCA180-043; EUDRACT Number: 2005-005153-22
Last updatedJuly 11, 2011
Record first receivedMay 1, 2006
ClinicalTrials.gov identifierNCT00320190
Download dateInformation obtained from ClinicalTrials.gov on February 23, 2012
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