Back to resultsStudy of BMS-354825 (Dasatinib) in Patients With Chronic Myeloid Leukemia Who Are Either Resistant or Intolerant to Imatinib
Primary Purpose
Chronic Myeloid Leukemia, Philadelphia-Positive Myeloid Leukemia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dasatinib
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Myeloid Leukemia focused on measuring Chronic phase Philadelphia chromosome chronic myeloid leukemia (Ph+CML)
Eligibility Criteria
Inclusion Criteria: Age of 18 years and older. Chronic myeloid leukemia (CML) Previous treatment with imatinib at a dose of >600 mg/day AND the development of progressive disease while receiving imatinib at that dose, OR CML with resistance to imatinib at a dose less than or equal to 600 mg/day with genetic mutation in the BCR-ABL gene that is associated with a high level of resistance to imatinib, OR Intolerance to imatinib at any dose Adequate organ function Women who are able to bear children must have a negative serum or urine pregnancy test. Adequate methods of contraception must be used throughout the study to avoid pregnancy for the entire interval of at least 1 month before and 3 months after completion of the study medication. Exclusion Criteria: Woman 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 Previous diagnosis of accelerated phase or blast crisis CML. Participants who are eligible and willing to undergo transplantation during the screening period Uncontrolled or significant cardiovascular disease 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 Use of certain medication that carry a known side effect risk of Torsade de Pointes - Certain medications that irreversibly inhibit platelet function or anticoagulants Prior therapy with dasatinib.
Sites / Locations
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dasatinib, 70 mg twice daily (BID)
Arm Description
Dasatanib, 70 mg twice daily (BID), with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
Outcomes
Primary Outcome Measures
Number of Imatinib-resistant Participants With Major Cytogenetic Response (MCyR)
Cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases plus Partial Cytogenetic Response (PCyR)-1% to 35% Ph+ metaphases.
Secondary Outcome Measures
Number of Imatinib-intolerant Participants With MCyR
Determination of cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of CCyR-0% Ph+ metaphases and PCyR - 1% to 35% Ph+ metaphases.
Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 and 24 Months
Based on the Kaplan-Meier estimate of the duration of response. Determination of cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases and Partial Cytogenetic Response (PCyR) - 1% to 35% Ph+ metaphases.
Median Time From First Dosing Date to Date of MCyR
MCyR is the combination of CCyR-0% Ph+ metaphases and PCyR - 1% to 35% Ph+ metaphases.
Number of Participants With Complete Hematologic Response (CHR)
CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets <450,000/mm^3; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.
Percentage of Participants Who Acheived CHR and Did Not Progress at 12 Months and 24 Months
Based on the Kaplan-Meier estimate of the duration of response. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm^3; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.
Median Time From First Dosing Until CHR
CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets <450,000/mm^3; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.
Number of Participants With Major Molecular Response (MMR)
MMR is defined as ≤3 log reduction 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.
Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores
Health-related quality of life as measured by FACT-G, which comprises 27 questions in 4 domains: PWB, SWB, EWB, FWB. Total FACT-G score=summation of the 4 subscale scores and ranges from 0 to 108. 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, and SWB score change of 2 or more=minimal clinical important change. Baseline FACT-G measurements can be found in Baseline Characteristics.
Number of Imitanib-intolerant Participants With Drug-related Adverse Events (AEs), Death Within 30 Days of Last Dose, Death, and AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Grade 3-4 Thrombocytopenia, Grade 4-4 Neutropenia, and Any AE
AE=any new untoward medical occurrence or worsening of a preexisting 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)
Number of Imitanib-resistant Participants With Drug-related AEs, Death Within 30 Days of Last Dose, Death, AEs Leading to Discontinuation, SAEs, Grade 3-4 Thrombocytopenia, Grade 3-4 Neutropenia, and Any AE
AE=any new untoward medical occurrence or worsening of a preexisting 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)
Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib
Blood samples were collected for PK to be included in separate population PK analyses.
Full Information
NCT ID
NCT00101660
First Posted
January 12, 2005
Last Updated
February 29, 2012
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT00101660
Brief Title
Study of BMS-354825 (Dasatinib) in Patients With Chronic Myeloid Leukemia Who Are Either Resistant or Intolerant to Imatinib
Official Title
A Phase II Study to Determine the Activity of BMS-354825 in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to High Dose Imatinib Mesylate (Gleevec) or Who Are Intolerant of Imatinib
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is assess the effects of the investigational drug dasatinib on participants who are in chronic phase Philadelphia chromosome chronic myeloid leukemia and who are either resistant to or intolerant of imatinib. Other purposes of the study are to identify any side effects the drug may produce and to study the level of dasatanib in the blood and assess the efficacy of dasatanib in the treatment of leukemia.
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 chronic myeloid leukemia (Ph+CML)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
387 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dasatinib, 70 mg twice daily (BID)
Arm Type
Experimental
Arm Description
Dasatanib, 70 mg twice daily (BID), with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Intervention Description
Tablets; oral; 70 mg BID, depending on response
Primary Outcome Measure Information:
Title
Number of Imatinib-resistant Participants With Major Cytogenetic Response (MCyR)
Description
Cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases plus Partial Cytogenetic Response (PCyR)-1% to 35% Ph+ metaphases.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of Imatinib-intolerant Participants With MCyR
Description
Determination of cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of CCyR-0% Ph+ metaphases and PCyR - 1% to 35% Ph+ metaphases.
Time Frame
Baseline to 2 years
Title
Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 and 24 Months
Description
Based on the Kaplan-Meier estimate of the duration of response. Determination of cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases and Partial Cytogenetic Response (PCyR) - 1% to 35% Ph+ metaphases.
Time Frame
12 and 24 Months
Title
Median Time From First Dosing Date to Date of MCyR
Description
MCyR is the combination of CCyR-0% Ph+ metaphases and PCyR - 1% to 35% Ph+ metaphases.
Time Frame
Baseline (within 4 weeks of Day 1) and every 12 weeks
Title
Number of Participants With Complete Hematologic Response (CHR)
Description
CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets <450,000/mm^3; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.
Time Frame
Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study
Title
Percentage of Participants Who Acheived CHR and Did Not Progress at 12 Months and 24 Months
Description
Based on the Kaplan-Meier estimate of the duration of response. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm^3; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.
Time Frame
12 and 24 months
Title
Median Time From First Dosing Until CHR
Description
CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets <450,000/mm^3; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.
Time Frame
Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study
Title
Number of Participants With Major Molecular Response (MMR)
Description
MMR is defined as ≤3 log reduction 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
Baseline to 2 years
Title
Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores
Description
Health-related quality of life as measured by FACT-G, which comprises 27 questions in 4 domains: PWB, SWB, EWB, FWB. Total FACT-G score=summation of the 4 subscale scores and ranges from 0 to 108. 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, and SWB score change of 2 or more=minimal clinical important change. Baseline FACT-G measurements can be found in Baseline Characteristics.
Time Frame
Baseline, Day 29, every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment, after end of treatment. Treatment continued until disease progression or development of toxicity or until other protocol-defined criteria.
Title
Number of Imitanib-intolerant Participants With Drug-related Adverse Events (AEs), Death Within 30 Days of Last Dose, Death, and AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Grade 3-4 Thrombocytopenia, Grade 4-4 Neutropenia, and Any AE
Description
AE=any new untoward medical occurrence or worsening of a preexisting 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
Number of Imitanib-resistant Participants With Drug-related AEs, Death Within 30 Days of Last Dose, Death, AEs Leading to Discontinuation, SAEs, Grade 3-4 Thrombocytopenia, Grade 3-4 Neutropenia, and Any AE
Description
AE=any new untoward medical occurrence or worsening of a preexisting 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
Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib
Description
Blood samples were collected for PK to be included in separate population PK analyses.
Time Frame
Day 8 of study; pretreatment through sample between 30 minutes and 3 hours following treatment, a sample between 5 hours 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:
Age of 18 years and older.
Chronic myeloid leukemia (CML)
Previous treatment with imatinib at a dose of >600 mg/day AND the development of progressive disease while receiving imatinib at that dose, OR
CML with resistance to imatinib at a dose less than or equal to 600 mg/day with genetic mutation in the BCR-ABL gene that is associated with a high level of resistance to imatinib, OR
Intolerance to imatinib at any dose
Adequate organ function
Women who are able to bear children must have a negative serum or urine pregnancy test. Adequate methods of contraception must be used throughout the study to avoid pregnancy for the entire interval of at least 1 month before and 3 months after completion of the study medication.
Exclusion Criteria:
Woman 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
Previous diagnosis of accelerated phase or blast crisis CML.
Participants who are eligible and willing to undergo transplantation during the screening period
Uncontrolled or significant cardiovascular disease
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
Use of certain medication that carry a known side effect risk of Torsade de Pointes - Certain medications that irreversibly inhibit platelet function or anticoagulants
Prior therapy with dasatinib.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
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Local Institution
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Anaheim
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California
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United States
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Loma Linda
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California
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United States
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Los Angeles
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California
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United States
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Stanford
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United States
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Vallejo
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Jacksonville
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Tampa
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Atlanta
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Chicago
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Indianapolis
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Kansas City
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Baltimore
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Boston
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St. Louis
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Omaha
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Hackensack
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New York
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Portland
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Philadelphia
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Pittsburgh
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Greenville
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Nashville
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Dallas
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Houston
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San Antonio
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Tyler
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Spokane
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St. Leonards
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New South Wales
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Australia
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South Brisbane
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Queensland
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Australia
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Adelaide
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Australia
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East Mebourne
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Victoria
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Australia
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Parkville
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Victoria
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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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Bruxelles
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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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Vancouver
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British Columbia
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Canada
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Toronto
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Ontario
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Canada
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Montreal
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Canada
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Aarhus
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Denmark
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Helsinki
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Finland
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Lille Cedex
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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 Cedex 10
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France
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Pessac
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France
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Poitiers Cedex
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France
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Strasbourg Cedex
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France
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Hamburg
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Germany
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Leipzig
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Germany
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Mainz
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Germany
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Mannheim
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Germany
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Co Galway
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Galway
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Ireland
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Dublin
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Ireland
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Ramat-Gan
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Israel
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Bari
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Italy
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Bologna
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Italy
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Milano
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Italy
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Napoli
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Italy
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Orbassano
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Italy
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Roma
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Italy
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Kyunggi-Do
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Korea, Republic of
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Nijmegen
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Netherlands
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Rotterdam
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Netherlands
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Trondheim
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Norway
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Lima
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Peru
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Singapore
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Singapore
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Parktown
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Gauteng
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South Africa
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Soweto
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Gauteng
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South Africa
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Barcelona
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Spain
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Madrid
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Spain
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Gothenburg
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Sweden
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Lund
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Sweden
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Stockholm
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Sweden
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Umea
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Sweden
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Uppsala
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Sweden
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Basel
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Switzerland
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Glasgow
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Central
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United Kingdom
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Local Institution
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London
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Greater London
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United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
17138817
Citation
Hochhaus A, Kantarjian HM, Baccarani M, Lipton JH, Apperley JF, Druker BJ, Facon T, Goldberg SL, Cervantes F, Niederwieser D, Silver RT, Stone RM, Hughes TP, Muller MC, Ezzeddine R, Countouriotis AM, Shah NP. Dasatinib induces notable hematologic and cytogenetic responses in chronic-phase chronic myeloid leukemia after failure of imatinib therapy. Blood. 2007 Mar 15;109(6):2303-9. doi: 10.1182/blood-2006-09-047266. Epub 2006 Nov 30. Erratum In: Blood. 2007 Sep 1;110(5):1438.
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
Study of BMS-354825 (Dasatinib) in Patients With Chronic Myeloid Leukemia Who Are Either Resistant or Intolerant to Imatinib
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