Back to resultsDasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia
Primary Purpose
Chronic Myeloid Leukemia, Philadelphia-Positive Myeloid Leukemia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dasatinib
Imatinib
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Myeloid Leukemia focused on measuring Chronic Phase Philadelphia chromosome Positive (Ph+) chronic myeloid leukemia
Eligibility Criteria
Inclusion Criteria: Men and women, 18 years of age or older. Subjects with Chronic Phase Ph+ CML. Subjects have not been treated with imatinib at a dose >600 mg/day. Subjects developed resistance to disease while receiving an imatinib dose 400-600 mg/day. Able to tolerate imatinib at the highest dose the subject had received in the past. Demonstrate adequate renal and hepatic function. Women of childbearing potential must have a negative serum or urine pregnancy test, must be using an adequate method of contraception. Exclusion Criteria: Women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period for a least 1 month before and at least 3 months after the completion of the study. Women using a prohibited contraceptive method. Women who are pregnant or breastfeeding. Men whose sexual partners are women who are of childbearing potential, and who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period as outlined above. Prior treatment with imatinib at a dose >600 mg/day. Subjects who have previously identified specific BCR-ABL mutations. Previous diagnosis of accelerated phase or blast crisis CML. Intolerance to imatinib at any dose. Subjects who are eligible and willing to undergo transplantation during the screening period. Serious uncontrolled medical disorder or active infection. Uncontrolled or significant cardiovascular disease. Uncontrolled hypertension. Dementia or altered mental status. Evidence of organ dysfunction. Use of imatinib within 7 days. Use of interferon or cytarabine within 14 days. Use of a targeted small molecule anticancer agent within 14 days. Subjects taking certain medications that are accepted to have a risk of causing Torsades de Pointes. Subjects taking medications that irreversibly inhibit platelet function or anticoagulants. Prior therapy with BMS-354825.
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Active Comparator
Active Comparator
Outcomes
Primary Outcome Measures
Number of Participants With Major Cytogenetic Response (MCyR) at Week 12
Cytogenetic response was based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as Complete CyR (CCyR; 0% Ph+ cells in metaphase in bone marrow) or Partial CyR (PCyR; >0% to 35% Ph+ cells in metaphase in bone marrow).
Secondary Outcome Measures
MCyR at Any Time Prior to Crossover
Cytogenetic response was based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as CCyR (0% Ph+ cells in metaphase in bone marrow) or PCyR (>0% to 35% Ph+ cells in metaphase in bone marrow).
Duration of MCyR at 12 Months and 18 Months
Percentage of participants who achieved MCyR and did not progress at 12 and 18 months.
Duration of MCyR at 24 Months
Percentage of participants who achieved MCyR and did not progress at 24 months.
Time to MCyR Prior to Crossover
Median time from first dosing date to date of MCyR
Complete Hematologic Response (CHR) at Any Time Prior to Crossover
Participants achieving CHR prior to crossover. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.
Duration of Complete Hematologic Response (CHR)
Percentage of participants who achieved CHR and did not progress at specified time points. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.
Time to CHR Prior to Crossover
Median time from first dosing date to date of CHR. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.
Major Molecular Response (MMR)
Number of participants Achieving MMR. MMR is defined as ≤3 log reduction (ie, international ratio ≤0.1), in BCR-ABL levels from the standardized baseline value of BCR-ABL: Control Gene ratio. The international ratio is obtained by multiplying BCR-ABL: Control gene ratio by the lab-specific conversion factor.
CHR After Crossover
Participants achieving CHR after crossover. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.
Cytogenetic Response After Crossover
Cytogenetic response was based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as Complete CyR (0% Ph+ cells in metaphase in bone marrow) or Partial CyR (>0% to 35% Ph+ cells in metaphase in bone marrow).
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)
Health-Related Quality of Life Prior to Crossover
Health-related quality of life as measured by Functional Assessment of Cancer Therapy-General (FACT-G). FACT-G=27 questions in 4 domains: physical, social/family, emotional, & functional well-being (PWB, SWB, EWB, FWB). Higher scores=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, & FWB score change of 3 or more, & SWB score change of 2 or more=minimal clinical important change.
Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib
Number of participants from which blood samples were collected for population PK studies.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00103844
Brief Title
Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia
Official Title
A Randomized Multi-Center Open Label Study of BMS-354825 vs. Imatinib Mesylate (Gleevec) 800 mg/d in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to Imatinib at a Dose at 400 - 600 mg/d
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of this study is to estimate the major cytogenetic response rates of BMS-354825 and imatinib (800 mg/d) in subjects with chronic phase, Philadelphia chromosome positive, chronic myeloid leukemia (PH+ CML) with disease resistant to imatinib at a dose of 400-600 mg/d.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia, Philadelphia-Positive Myeloid Leukemia
Keywords
Chronic Phase Philadelphia chromosome Positive (Ph+) chronic myeloid leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Active Comparator
Arm Title
2
Arm Type
Experimental
Arm Description
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Other Intervention Name(s)
Sprycel, BMS-354825
Intervention Description
Tablets, oral, 20 mg and 50mg, twice daily, up to 96 weeks
Intervention Type
Drug
Intervention Name(s)
Imatinib
Intervention Description
Tablets, Oral, 400mg and 100mg, twice daily, up to 96 weeks
Primary Outcome Measure Information:
Title
Number of Participants With Major Cytogenetic Response (MCyR) at Week 12
Description
Cytogenetic response was based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as Complete CyR (CCyR; 0% Ph+ cells in metaphase in bone marrow) or Partial CyR (PCyR; >0% to 35% Ph+ cells in metaphase in bone marrow).
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
MCyR at Any Time Prior to Crossover
Description
Cytogenetic response was based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as CCyR (0% Ph+ cells in metaphase in bone marrow) or PCyR (>0% to 35% Ph+ cells in metaphase in bone marrow).
Time Frame
Baseline (within 4 weeks of Day 1), every 12 weeks until crossover or off-study timepoints. Restricted to precrossover measurements.
Title
Duration of MCyR at 12 Months and 18 Months
Description
Percentage of participants who achieved MCyR and did not progress at 12 and 18 months.
Time Frame
12 months, 18 months
Title
Duration of MCyR at 24 Months
Description
Percentage of participants who achieved MCyR and did not progress at 24 months.
Time Frame
24 Months
Title
Time to MCyR Prior to Crossover
Description
Median time from first dosing date to date of MCyR
Time Frame
Baseline (within 4 weeks of Day 1), every 12 weeks, at crossover or off-study timepoints; restricted to precrossover measurements.
Title
Complete Hematologic Response (CHR) at Any Time Prior to Crossover
Description
Participants achieving CHR prior to crossover. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.
Time Frame
Baseline (within 4 weeks of Day 1), weekly until Week 12 and then every 12 weeks until crossover or off-study; restricted to precrossover measurements.
Title
Duration of Complete Hematologic Response (CHR)
Description
Percentage of participants who achieved CHR and did not progress at specified time points. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.
Time Frame
12 months, 24 months
Title
Time to CHR Prior to Crossover
Description
Median time from first dosing date to date of CHR. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.
Time Frame
Baseline (within 4 weeks of Day 1), weekly until Week 12, then every 12 weeks until crossover or off-study; restricted to precrossover measurements.
Title
Major Molecular Response (MMR)
Description
Number of participants Achieving MMR. MMR is defined as ≤3 log reduction (ie, international ratio ≤0.1), in BCR-ABL levels from the standardized baseline value of BCR-ABL: Control Gene ratio. The international ratio is obtained by multiplying BCR-ABL: Control gene ratio by the lab-specific conversion factor.
Time Frame
Pretreatment, then after every 4 weeks for 12 weeks, then after every 12 week period out to 2 years; restricted to precrossover measurements.
Title
CHR After Crossover
Description
Participants achieving CHR after crossover. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.
Time Frame
Weekly for 12 weeks, then after every 12 week period out to 2 years; restricted to postcrossover measurements.
Title
Cytogenetic Response After Crossover
Description
Cytogenetic response was based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as Complete CyR (0% Ph+ cells in metaphase in bone marrow) or Partial CyR (>0% to 35% Ph+ cells in metaphase in bone marrow).
Time Frame
every 12 week period out to 2 years and off-study timepoints; restricted to postcrossover measurements
Title
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover
Description
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)
Time Frame
Continuously from baseline through 2 years
Title
Health-Related Quality of Life Prior to Crossover
Description
Health-related quality of life as measured by Functional Assessment of Cancer Therapy-General (FACT-G). FACT-G=27 questions in 4 domains: physical, social/family, emotional, & functional well-being (PWB, SWB, EWB, FWB). Higher scores=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, & FWB score change of 3 or more, & SWB score change of 2 or more=minimal clinical important change.
Time Frame
Every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment. Last questionnaire was to be completed at first follow-up visit after off-study date.
Title
Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib
Description
Number of participants from which blood samples were collected for population PK studies.
Time Frame
Day 8: pretreatment trough sample, a sample between 30 minutes and 3 hours following treatment, a sample between 5 and 8 hours following treatment, and a sample at 12 hours, prior to the next dose.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women, 18 years of age or older.
Subjects with Chronic Phase Ph+ CML.
Subjects have not been treated with imatinib at a dose >600 mg/day.
Subjects developed resistance to disease while receiving an imatinib dose 400-600 mg/day.
Able to tolerate imatinib at the highest dose the subject had received in the past.
Demonstrate adequate renal and hepatic function.
Women of childbearing potential must have a negative serum or urine pregnancy test, must be using an adequate method of contraception.
Exclusion Criteria:
Women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period for a least 1 month before and at least 3 months after the completion of the study.
Women using a prohibited contraceptive method.
Women who are pregnant or breastfeeding.
Men whose sexual partners are women who are of childbearing potential, and who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period as outlined above.
Prior treatment with imatinib at a dose >600 mg/day.
Subjects who have previously identified specific BCR-ABL mutations.
Previous diagnosis of accelerated phase or blast crisis CML.
Intolerance to imatinib at any dose.
Subjects who are eligible and willing to undergo transplantation during the screening period.
Serious uncontrolled medical disorder or active infection.
Uncontrolled or significant cardiovascular disease.
Uncontrolled hypertension.
Dementia or altered mental status.
Evidence of organ dysfunction.
Use of imatinib within 7 days.
Use of interferon or cytarabine within 14 days.
Use of a targeted small molecule anticancer agent within 14 days.
Subjects taking certain medications that are accepted to have a risk of causing Torsades de Pointes.
Subjects taking medications that irreversibly inhibit platelet function or anticoagulants.
Prior therapy with BMS-354825.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
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Birmingham
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Anaheim
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Stanford
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Vallejo
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Atlanta
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Lawrenceville
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Tucker
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Chicago
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Cordoba
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Argentina
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Camperdown
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Australia
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St. Leonards
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Australia
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Adelaide
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Australia
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Perth
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Australia
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Wein
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Austria
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B-Leuven
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Belgium
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Brugge
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Belgium
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Bruxelles
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Belgium
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Charleroi
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Belgium
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Edegem
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Belgium
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Yvoir
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Belgium
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Curitiba
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Parana
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Brazil
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Rio De Janeiro
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Brazil
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Edmonton
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China
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China
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Denmark
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Tallin
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Estonia
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Helsinki
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Finland
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Lille
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France
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Lyon Cedex 03
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France
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Nantes
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France
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Paris
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France
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Pessac
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France
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Poitiers
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France
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Strasbourg Cedex
Country
France
Facility Name
Local Institution
City
Dresden
Country
Germany
Facility Name
Local Institution
City
Groenkloof
Country
Germany
Facility Name
Local Institution
City
Hamburg
Country
Germany
Facility Name
Local Institution
City
Leipzig
Country
Germany
Facility Name
Local Institution
City
Mainz
Country
Germany
Facility Name
Local Institution
City
Mannheim
Country
Germany
Facility Name
Local Institution
City
Budapest
Country
Hungary
Facility Name
Local Institution
City
Dublin
Country
Ireland
Facility Name
Local Institution
City
Ramat-Gan
Country
Israel
Facility Name
Local Institution
City
Bari
Country
Italy
Facility Name
Local Institution
City
Bologna
Country
Italy
Facility Name
Local Institution
City
Milano
Country
Italy
Facility Name
Local Institution
City
Napoli
Country
Italy
Facility Name
Local Institution
City
Orbassano
Country
Italy
Facility Name
Local Institution
City
Roma
Country
Italy
Facility Name
Local Institution
City
Kyunggi-Do
Country
Korea, Republic of
Facility Name
Local Institution
City
Trondheim
Country
Norway
Facility Name
Local Institution
City
Lima
Country
Peru
Facility Name
Local Institution
City
Quezon City
Country
Philippines
Facility Name
Local Institution
City
Katowice
Country
Poland
Facility Name
Local Institution
City
Krakow
Country
Poland
Facility Name
Local Institution
City
Lublin
Country
Poland
Facility Name
Local Institution
City
Warsaw
Country
Poland
Facility Name
Local Institution
City
San Juan
Country
Puerto Rico
Facility Name
Local Institution
City
Moscow
Country
Russian Federation
Facility Name
Local Institution
City
St. Petersburg
Country
Russian Federation
Facility Name
Local Institution
City
Singapore
Country
Singapore
Facility Name
Local Institution
City
Bloemfontein
State/Province
Free State
Country
South Africa
Facility Name
Local Institution
City
Parktown
State/Province
Gauteng
Country
South Africa
Facility Name
Local Institution
City
Soweto
State/Province
Gauteng
Country
South Africa
Facility Name
Local Institution
City
Barcelona
Country
Spain
Facility Name
Local Institution
City
Madrid
Country
Spain
Facility Name
Local Institution
City
Gothenburg
Country
Sweden
Facility Name
Local Institution
City
Lund
Country
Sweden
Facility Name
Local Institution
City
Stockholm
Country
Sweden
Facility Name
Local Institution
City
Umea
Country
Sweden
Facility Name
Local Institution
City
Uppsala
Country
Sweden
Facility Name
Local Institution
City
Basel
Country
Switzerland
Facility Name
Local Institution
City
Bellinzona
Country
Switzerland
Facility Name
Local Institution
City
Taipei
Country
Taiwan
Facility Name
Local Institution
City
Taoyuan
Country
Taiwan
Facility Name
Local Institution
City
Bangkok
Country
Thailand
Facility Name
Local Institution
City
Glasglow
State/Province
Central
Country
United Kingdom
Facility Name
Local Institution
City
London
State/Province
Greater London
Country
United Kingdom
Facility Name
Local Institution
City
Newcastle
State/Province
Tyne and Wear
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19536906
Citation
Kantarjian H, Pasquini R, Levy V, Jootar S, Holowiecki J, Hamerschlak N, Hughes T, Bleickardt E, Dejardin D, Cortes J, Shah NP. Dasatinib or high-dose imatinib for chronic-phase chronic myeloid leukemia resistant to imatinib at a dose of 400 to 600 milligrams daily: two-year follow-up of a randomized phase 2 study (START-R). Cancer. 2009 Sep 15;115(18):4136-47. doi: 10.1002/cncr.24504.
Results Reference
background
PubMed Identifier
19779040
Citation
Muller MC, Cortes JE, Kim DW, Druker BJ, Erben P, Pasquini R, Branford S, Hughes TP, Radich JP, Ploughman L, Mukhopadhyay J, Hochhaus A. Dasatinib treatment of chronic-phase chronic myeloid leukemia: analysis of responses according to preexisting BCR-ABL mutations. Blood. 2009 Dec 3;114(24):4944-53. doi: 10.1182/blood-2009-04-214221. Epub 2009 Sep 24.
Results Reference
background
Learn more about this trial
Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia
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