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Insufficient Enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | 50-180 mg once daily (QD) |
|
| B | Active Comparator | 200-800 mg QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib | Drug | Tablets, Oral, Once daily, 5-7 years |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Cytogenetic Response (CCyR) Rate at Month 6 | Cytogenetic Response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Major Molecular Response (MMR) Rates | MMR is defined as a 3-log reduction in BCR-ABL gene transcripts from a standardized baseline. Reductions in BCR-ABL transcripts on logarithmic scale are calculated based on the absolute values expressed as percent of ratio of BCR-ABL gene transcripts to the control gene. In this study,ABL was used as the control gene. | Month 3, Month 6, Month 12, Month 24 and Month 36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Marshall Schreeder | Huntsville | Alabama | 35805 | United States | ||
| Local Institution |
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A total of 156 subjects were to be enrolled; however, the attempts were unsuccessful and the study was closed after 3 subjects were enrolled. A fourth subject underwent screening, but was not randomized since the subject did not meet the inclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dasatinib | 100 mg once daily (QD) |
| FG001 | Imatinib | 600 mg QD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Imatinib | Drug | Tablets, Oral, Once daily, 5-7 years |
|
| CCyR Rates | CyR is based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample. | Month 3, Month 12, Month 24 and Month 36 |
| Estimate Time to MMR and CCyR | Time to MMR is defined as the time from first treatment dose until measurement criteria are first met for MMR. Time to MMR is computed only for subjects who achieved a MMR. Time to CCyR is defined as the time from first treatment dose until measurement criteria are first met for CCyR. Time to CCyR is computed only for subjects who achieved a CCyR. | throughout the study |
| Progression Free Survival (PFS) | PFS=time from randomization until progression or death. Participants who died without progression=progression on date of death. Participants who neither progressed nor died were censored on date of last hematologic assessment. Participants who did not receive study treatment and neither progressed nor died were censored on date of randomization. | at 36 months |
| Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs | An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. | 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. |
| Duration of CCyR and MMR | Duration of CCyR computed for subjects with CCyR as best response; measured from time the criteria are first met for CCyR until date of progression or death. Duration of MMR computed for subjects with MMR as best response; measured from time the criteria are first met for MMR until date the MMR was first lost, disease progression or death. | Throughout the study |
| Best MMR Rates | MMR is defined as a 3-log reduction in BCR-ABL gene transcripts from a standardized baseline. Reductions in BCR-ABL transcripts on logarithmic scale are calculated based on the absolute values expressed as % of ratio of BCR-ABL gene transcripts to the control gene. In this study, ABL was used as the control gene. | throughout study |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Local Institution | Alhambra | California | 91801 | United States |
| Local Institution | Anaheim | California | 92801 | United States |
| Local Institution | Beverly Hills | California | 90211 | United States |
| Local Institution | Fullerton | California | 92835 | United States |
| Local Institution | La Jolla | California | 92093 | United States |
| Local Institution | La Verne | California | 91750 | United States |
| Local Institution | Long Beach | California | 90813 | United States |
| Local Institution | Los Angeles | California | 90033 | United States |
| Local Institution | Los Angeles | California | 90048 | United States |
| Local Institution | Los Angeles | California | 90095 | United States |
| Local Institution | Northridge | California | 91325 | United States |
| Local Institution | Oxnard | California | 93030 | United States |
| Local Institution | Redondo Beach | California | 90277 | United States |
| Local Institution | San Francisco | California | 94143 | United States |
| Local Institution | Santa Maria | California | 93454 | United States |
| Local Institution | Stanford | California | 94305 | United States |
| Local Institution | Aurora | Colorado | 80045 | United States |
| Local Institution | Jacksonville | Florida | 32207 | United States |
| Local Institution | Jacksonville | Florida | 32209 | United States |
| M.D. Anderson Cancer Center Orlando | Orlando | Florida | 32806 | United States |
| Local Institution | Pembroke Pines | Florida | 33028 | United States |
| Local Institution | Chicago | Illinois | 60637 | United States |
| Local Institution | Indianapolis | Indiana | 46202 | United States |
| Local Institution | Kansas City | Kansas | 66160 | United States |
| Local Institution | Hazard | Kentucky | 41701 | United States |
| Local Institution | Ann Arbor | Michigan | 48109 | United States |
| Local Institution | Rochester | Minnesota | 55905 | United States |
| Local Institution | St Louis | Missouri | 63110 | United States |
| Local Institution | Omaha | Nebraska | 68114 | United States |
| Local Institution | Las Vegas | Nevada | 89135 | United States |
| Local Institution | Hackensack | New Jersey | 07601 | United States |
| Local Institution | Buffalo | New York | 14263 | United States |
| New York Presbyterian Hospital | New York | New York | 10021 | United States |
| New York Medical College | Valhalla | New York | 10595 | United States |
| Local Institution | Durham | North Carolina | 27710 | United States |
| Local Institution | Cleveland | Ohio | 44195 | United States |
| Local Institution | Oklahoma City | Oklahoma | 73112 | United States |
| Local Institution | Tulsa | Oklahoma | 74136 | United States |
| Local Institution | Baltimore | Pennsylvania | 21229 | United States |
| Local Institution | Pittsburgh | Pennsylvania | 15232 | United States |
| Santee Hematology/Oncology | Sumter | South Carolina | 29150 | United States |
| Local Institution | Dallas | Texas | 75390 | United States |
| Local Institution | Houston | Texas | 77030 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dasatinib | 100 mg QD |
| BG001 | Imatinib | 600 mg QD |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Number | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Cytogenetic Response (CCyR) Rate at Month 6 | Cytogenetic Response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample. | This analysis was not done. This study was terminated due to insufficient enrollment. | Posted | Number | participants | Month 6 |
|
| ||||||||||||||||||||
| Secondary | Major Molecular Response (MMR) Rates | MMR is defined as a 3-log reduction in BCR-ABL gene transcripts from a standardized baseline. Reductions in BCR-ABL transcripts on logarithmic scale are calculated based on the absolute values expressed as percent of ratio of BCR-ABL gene transcripts to the control gene. In this study,ABL was used as the control gene. | This analysis was not done. This study was terminated due to insufficient enrollment. | Posted | Number | participants | Month 3, Month 6, Month 12, Month 24 and Month 36 |
|
| ||||||||||||||||||||
| Secondary | CCyR Rates | CyR is based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample. | This analysis was not done. This study was terminated due to insufficient enrollment. | Posted | Number | Participants | Month 3, Month 12, Month 24 and Month 36 |
|
| ||||||||||||||||||||
| Secondary | Estimate Time to MMR and CCyR | Time to MMR is defined as the time from first treatment dose until measurement criteria are first met for MMR. Time to MMR is computed only for subjects who achieved a MMR. Time to CCyR is defined as the time from first treatment dose until measurement criteria are first met for CCyR. Time to CCyR is computed only for subjects who achieved a CCyR. | This analysis was not done. This study was terminated due to insufficient enrollment. | Posted | Number | months | throughout the study |
|
| ||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS=time from randomization until progression or death. Participants who died without progression=progression on date of death. Participants who neither progressed nor died were censored on date of last hematologic assessment. Participants who did not receive study treatment and neither progressed nor died were censored on date of randomization. | This analysis was not done. This study was terminated due to insufficient enrollment. | Posted | Number | participants | at 36 months |
|
| ||||||||||||||||||||
| Secondary | Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs | An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. | All treated participants | Posted | Number | events | 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. |
|
| ||||||||||||||||||||
| Secondary | Duration of CCyR and MMR | Duration of CCyR computed for subjects with CCyR as best response; measured from time the criteria are first met for CCyR until date of progression or death. Duration of MMR computed for subjects with MMR as best response; measured from time the criteria are first met for MMR until date the MMR was first lost, disease progression or death. | This analysis was not done. This study was terminated due to insufficient enrollment. | Posted | Number | months | Throughout the study |
|
| ||||||||||||||||||||
| Secondary | Best MMR Rates | MMR is defined as a 3-log reduction in BCR-ABL gene transcripts from a standardized baseline. Reductions in BCR-ABL transcripts on logarithmic scale are calculated based on the absolute values expressed as % of ratio of BCR-ABL gene transcripts to the control gene. In this study, ABL was used as the control gene. | This analysis was not done. This study was terminated due to insufficient enrollment. | Posted | Number | participants | throughout study |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dasatinib | 100 mg once daily (QD) | 0 | 2 | 2 | 2 | ||
| EG001 | Imatinib | 600 mg QD | 0 | 1 | 1 | 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypokalemia | Investigations | MedDRA 10.0 | Systematic Assessment |
|
Study was terminated early due to insufficient enrollment.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007951 | Leukemia, Myeloid |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D001549 | Benzamides |
| D000577 | Amides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
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| Title | Measurements |
|---|---|
|
| 50- to 59-years-old |
|
| Male |
|
|