A Phase 1 interventional study of Dasatinib in Leukemia, sponsored by Bristol-Myers Squibb. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-04-28.
Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment
To determine the long term safety and tolerability of dasatinib exposure in subjects previously treated in CA180-002.
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This study enrolled participants with Philadelphia chromosome positive (Ph+)chronic myelogenous leukemia (CML) or Ph+ acute lymphoblastic leukemia (ALL) who had demonstrated hematologic resistance or intolerance to imatinib mesylate (Gleevec) and had experienced clinical benefit (in Investigator's opinion) on protocol CA180002.
Inclusion Criteria:
Exclusion Criteria:
Medical History and Concurrent Diseases
History of significant bleeding disorder unrelated to CML, including:
Physical and Laboratory Test Findings
Prohibited Therapies and/or Medications
Patients currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes including:
Drug: Dasatinib
Tablets, Oral, The dosing ranges from 50mg to a total of 240mg daily with the following 3 schedules: * 5 days on, 2 days off * 6 days on, 1 day off * Continuous daily dosing Once Daily (QD) or Twice Daily (BID) dosing, Subjects will be treated until progression of disease despite escalation/reductions of dose to the level deemed safe by available data, until intolerable/unacceptable toxicity or until subject withdrawal from the study or discontinuation of the study
Also known as: BMS-354825, Sprycel, Src Kinase
Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation.
AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to AEs were recorded. These data differ from that in the Participant Flow section. This is because the data were collected on 2 different pages of the Case Report Form and were not reconciled.
Time frame: From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months.
Number of Participants Who Experienced Drug-related AEs and Drug-related SAEs.
Drug-related AEs are those events with a relationship to the study therapy of certain; probable; or possible or missing. Drug-related SAEs are those events with any relationship to the study therapy.
Time frame: From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months.
Number of Participants With Grade 3-4 Hematology Abnormalities
Abnormalities were graded per the National Cancer Institute(NCI)Common Toxicity Criteria (CTC), v3.0(Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: Hemoglobin: Grade 3:6.5 - \<8.0g/dL, Grade 4: \<6.5g/dL. Platelets: Grade 3: 25.0 - \<50.0\*10\^9/L, Grade 4: \<25.0\*10. Absolute Neutrophil Count (ANC): Grade 3: 0.5 - \<1.0\*10\^9/L, Grade 4: \<0.5\*10\^9/L.White Blood Cells (WBC) : Grade 3: 1.0 - \<2.0\*10\^9/L, Grade 4: \<1.0\*10\^9/L.
Time frame: From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months.
Number of Participants With Grade 3-4 Serum Chemistry Abnormalities
Abnormalities were graded per the NCI (CTC), v3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: Alanine aminotransferase (ALT): Grade 3: 5.0-20.0 \* ULN (upper limit of normal), Grade 4: \>20.0 \* ULN; Calcium: Grade 3: 6.0-\<7.0 or \>12.5-13.5 mg/dL, Grade 4: \<0.6-\>13.5 mg/dL; Bilirubin: Grade 3: \>3-10 \* ULN, Grade 4: \>10 \* ULN; Creatinine: Grade 3: \>3.0-6.0 \* ULN, Grade 4: \>6.0 \* ULN; Albumin: Grade 3: \<2g/dL (Grade 4 not defined in NCI CTC); Magnesium: Grade 3: 0.6-\<0.8 or \>2.46-6.6mEq/L, Grade 4: \<0.6 or \>6.6mEq/L.
Time frame: From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months.
Number of Participants With Dose Interruptions and Dose Reductions
Dose interruptions and reductions were allowed, in order to optimize individual participant's hematologic, cytogenetic, and molecular response while maintaining and evaluating safety and tolerability of long-term exposure to dasatinib. A dose reduction is defined as the administration of a dose at a lower level compared to previous dose and such that reduced dose, or a lower dose, is given at least 4 consecutive times. In determining the reductions, dose level would be compared to the previous non-null dose. Dose interruption is defined as a complete omission of dosing for 4 consecutive times.
Time frame: From start of study to final assessment (up to 32.2 months).
Number of Participants With Complete Hematologic Response (CHR)
CHR should meet all of the following criteria: WBC \<= Institutional ULN; ANC \>= 1000/mm\^3 ; Platelets \< 450 000/mm\^3 , no blasts or promyelocytes in peripheral blood; \< 5% myelocytes plus metamyelocytes in peripheral blood; basophils in peripheral blood \< 20% and no extramedullary involvement (including no hepatomegaly or splenomegaly). CHR can begin only 14 days after the start of treatment.
Time frame: Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.
Median Number of Months of CHR (Kaplan Meier Method)
CHR: WBC\<=ULN (range: 9.29-12.5\*10\^3 c\\uL); ANC \>=1000/mm\^3;Platelets \<450000/mm\^3,no blasts/promyelocytes in peripheral blood; \<5% myelocytes+metamyelocytes in peripheral blood; basophils in peripheral blood \<20% \& no extramedullary involvement. Duration computed for chronic phase participants, measured in months from first day CHR criteria met, provided they are confirmed 4 weeks later, until progression of disease, treatment discontinuation due to progressive disease or death. Participants who neither discontinue due to progression, nor progress nor die censored on date of last assessment.
Time frame: Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.
Number of Participants With Major Cytogenetic Response (MCyR)
Cytogenetic responses are based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample. MCyR is defined as number of participants with Complete Cytogenetic Response (CCyR): 0% Ph+ cells in metaphase in bone marrow or Partial Cytogenetic Response (PCyR): \>0% to 35% Ph+ cells in metaphase in bone marrow.
Time frame: Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.
Median Number of Months of Major Cytogenetic Response (MCyR)
MCyR: 0% Ph+ cells in metaphase in bone marrow or Partial Cytogenetic Response (PCyR): \>0% to 35% Ph+ cells in metaphase in bone marrow.The duration of MCyR was computed for chronic phase participants whose best response is either CCyR or PCyR. It was measured in months from the time measurement criteria are first met for CCyR or PCyR (whichever status is recorded first) until the date of progression or death. Participants who neither progress nor die are censored on the date of their last cytogenetic assessment.
Time frame: Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.
Number of Participants With Best Cytogenetic Response
Cytogenetic responses are based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample. CCyR: 0% Ph+ cells in metaphase in bone marrow, PCyR: \>0% to 35% Ph+ cells in metaphase in bone marrow, Minor CyR: \>35% to 65% Ph+ cells in metaphase in bone marrow, Minimal CyR: \>65% to 95% Ph+ cells in metaphase in bone marrow and No CyR: \>95% to 100% Ph+ cells in metaphase in bone marrow.
Time frame: Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.
Median Number of Months of Progression-free Survival (PFS) (Kaplan Meier Method)
Interval between randomization date \& earliest date of disease progression/death due to any cause, assessed by the Independent Radiology Review Committee (IRRC) using modified World Health Organization (WHO) criteria to define progressive disease (PD): \>=25% increase in sum of products of diameters (SOPD) of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion. If no progression/death, date of last tumor assessment used. For participants who had no on-study tumor assessments \& were still alive, date of randomization used.
Time frame: Baseline to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.
Median Number of Months of Overall Survival (OS) (Kaplan Meier Method)
Overall survival was defined as the median number of months from baseline to death from any cause.
Time frame: Baseline to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.
| Milestone | Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry | CML: BID Dosing at Study Entry | Accelerated Phase CML: BID Dosing at Study Entry | Myeloid Blast Phase CML: BID Dosing at Study Entry |
|---|---|---|---|---|
| Started | 22 | 15 | 5 | 4 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 22 | 15 | 5 | 4 |
| Withdrew: Death | 4 | 1 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 1 |
| Withdrew: Adverse event | 5 | 2 | 0 | 0 |
| Withdrew: Participant's request | 1 | 0 | 0 | 0 |
| Withdrew: Administrative reason | 3 | 3 | 1 | 0 |
| Withdrew: Deterioration without progression | 0 | 1 | 0 | 0 |
| Withdrew: Disease progression/relapse | 5 | 4 | 2 | 2 |
| Withdrew: Study closure | 3 | 4 | 1 | 1 |
| Withdrew: No response | 1 | 0 | 0 | 0 |
AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to AEs were recorded. These data differ from that in the Participant Flow section. This is because the data were collected on 2 different pages of the Case Report Form and were not reconciled.
| participants | Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry | CML: BID Dosing at Study Entry | Accelerated Phase CML: BID Dosing at Study Entry | Myeloid Blast Phase CML: BID Dosing at Study Entry |
|---|---|---|---|---|
| Deaths | 3 | 2 | 1 | 1 |
| SAEs | 10 | 9 | 3 | 3 |
| AEs | 22 | 15 | 5 | 4 |
| Discontinuation due to AEs | 4 | 3 | 1 | 0 |
Drug-related AEs are those events with a relationship to the study therapy of certain; probable; or possible or missing. Drug-related SAEs are those events with any relationship to the study therapy.
| participants | Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry | CML: BID Dosing at Study Entry | Accelerated Phase CML: BID Dosing at Study Entry | Myeloid Blast Phase CML: BID Dosing at Study Entry |
|---|---|---|---|---|
| Drug-related AEs | 14 | 9 | 3 | 3 |
| Drug-related SAEs | 4 | 4 | 1 | 1 |
Abnormalities were graded per the National Cancer Institute(NCI)Common Toxicity Criteria (CTC), v3.0(Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: Hemoglobin: Grade 3:6.5 - \<8.0g/dL, Grade 4: \<6.5g/dL. Platelets: Grade 3: 25.0 - \<50.0\*10\^9/L, Grade 4: \<25.0\*10. Absolute Neutrophil Count (ANC): Grade 3: 0.5 - \<1.0\*10\^9/L, Grade 4: \<0.5\*10\^9/L.White Blood Cells (WBC) : Grade 3: 1.0 - \<2.0\*10\^9/L, Grade 4: \<1.0\*10\^9/L.
| participants | Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry | CML: BID Dosing at Study Entry | Accelerated Phase CML: BID Dosing at Study Entry | Myeloid Blast Phase CML: BID Dosing at Study Entry |
|---|---|---|---|---|
| WBC | 2 | 1 | 0 | 0 |
| ANC | 3 | 1 | 0 | 2 |
| Platelet Count | 3 | 1 | 0 | 1 |
| Hemoglobin | 0 | 1 | 1 | 1 |
CHR should meet all of the following criteria: WBC \<= Institutional ULN; ANC \>= 1000/mm\^3 ; Platelets \< 450 000/mm\^3 , no blasts or promyelocytes in peripheral blood; \< 5% myelocytes plus metamyelocytes in peripheral blood; basophils in peripheral blood \< 20% and no extramedullary involvement (including no hepatomegaly or splenomegaly). CHR can begin only 14 days after the start of treatment.
| participants | Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry | CML: BID Dosing at Study Entry | Accelerated Phase CML: BID Dosing at Study Entry | Myeloid Blast Phase CML: BID Dosing at Study Entry |
|---|---|---|---|---|
| Number of Participants With Complete Hematologic Response (CHR) | 16 (49.8 to 89.3) | 13 (59.5 to 98.3) | — | — |
CHR: WBC\<=ULN (range: 9.29-12.5\*10\^3 c\\uL); ANC \>=1000/mm\^3;Platelets \<450000/mm\^3,no blasts/promyelocytes in peripheral blood; \<5% myelocytes+metamyelocytes in peripheral blood; basophils in peripheral blood \<20% \& no extramedullary involvement. Duration computed for chronic phase participants, measured in months from first day CHR criteria met, provided they are confirmed 4 weeks later, until progression of disease, treatment discontinuation due to progressive disease or death. Participants who neither discontinue due to progression, nor progress nor die censored on date of last assessment.
| months | Participants With Chronic Myelogenous Leukemia (CML) |
|---|---|
| Median Number of Months of CHR (Kaplan Meier Method) | 52.0 (31.9 to NA) |
Cytogenetic responses are based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample. MCyR is defined as number of participants with Complete Cytogenetic Response (CCyR): 0% Ph+ cells in metaphase in bone marrow or Partial Cytogenetic Response (PCyR): \>0% to 35% Ph+ cells in metaphase in bone marrow.
| participants | Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry | Participants With CML: BID Dosing at Study Entry |
|---|---|---|
| Number of Participants With Major Cytogenetic Response (MCyR) | 13 | 9 |
Abnormalities were graded per the NCI (CTC), v3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: Alanine aminotransferase (ALT): Grade 3: 5.0-20.0 \* ULN (upper limit of normal), Grade 4: \>20.0 \* ULN; Calcium: Grade 3: 6.0-\<7.0 or \>12.5-13.5 mg/dL, Grade 4: \<0.6-\>13.5 mg/dL; Bilirubin: Grade 3: \>3-10 \* ULN, Grade 4: \>10 \* ULN; Creatinine: Grade 3: \>3.0-6.0 \* ULN, Grade 4: \>6.0 \* ULN; Albumin: Grade 3: \<2g/dL (Grade 4 not defined in NCI CTC); Magnesium: Grade 3: 0.6-\<0.8 or \>2.46-6.6mEq/L, Grade 4: \<0.6 or \>6.6mEq/L.
| participants | Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry | CML: BID Dosing at Study Entry | Accelerated Phase CML: BID Dosing at Study Entry | Myeloid Blast Phase CML: BID Dosing at Study Entry |
|---|---|---|---|---|
| Low Albumin | 1 | 0 | 0 | 0 |
| High ALT | 1 | 1 | 0 | 0 |
| High Total Bilirubin | 0 | 0 | 0 | 0 |
| Low Calcium | 0 | 0 | 0 | 0 |
| Low Magnesium | 0 | 0 | 0 | 0 |
| High Serum Creatinine | 0 | 0 | 0 | 0 |
MCyR: 0% Ph+ cells in metaphase in bone marrow or Partial Cytogenetic Response (PCyR): \>0% to 35% Ph+ cells in metaphase in bone marrow.The duration of MCyR was computed for chronic phase participants whose best response is either CCyR or PCyR. It was measured in months from the time measurement criteria are first met for CCyR or PCyR (whichever status is recorded first) until the date of progression or death. Participants who neither progress nor die are censored on the date of their last cytogenetic assessment.
| months | Participants With Chronic Myelogenous Leukemia (CML) |
|---|---|
| Median Number of Months of Major Cytogenetic Response (MCyR) | 50.1 (27.1 to 50.1) |
Dose interruptions and reductions were allowed, in order to optimize individual participant's hematologic, cytogenetic, and molecular response while maintaining and evaluating safety and tolerability of long-term exposure to dasatinib. A dose reduction is defined as the administration of a dose at a lower level compared to previous dose and such that reduced dose, or a lower dose, is given at least 4 consecutive times. In determining the reductions, dose level would be compared to the previous non-null dose. Dose interruption is defined as a complete omission of dosing for 4 consecutive times.
| participants | Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry | CML: BID Dosing at Study Entry | Accelerated Phase CML: BID Dosing at Study Entry | Myeloid Blast Phase CML: BID Dosing at Study Entry |
|---|---|---|---|---|
| Dose interruptions | 7 | 9 | 2 | 2 |
| Dose reductions | 8 | 4 | 2 | 1 |
Cytogenetic responses are based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample. CCyR: 0% Ph+ cells in metaphase in bone marrow, PCyR: \>0% to 35% Ph+ cells in metaphase in bone marrow, Minor CyR: \>35% to 65% Ph+ cells in metaphase in bone marrow, Minimal CyR: \>65% to 95% Ph+ cells in metaphase in bone marrow and No CyR: \>95% to 100% Ph+ cells in metaphase in bone marrow.
| participants | Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry | Participants With CML: BID Dosing at Study Entry |
|---|---|---|
| Complete (0%) | 10 | 7 |
| Partial (1-35%) | 3 | 2 |
| Minor (36-65%) | 0 | 1 |
| Minimal (66-95%) | 3 | 1 |
| No response | 4 | 3 |
| Unable to determine | 2 | 1 |
Interval between randomization date \& earliest date of disease progression/death due to any cause, assessed by the Independent Radiology Review Committee (IRRC) using modified World Health Organization (WHO) criteria to define progressive disease (PD): \>=25% increase in sum of products of diameters (SOPD) of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion. If no progression/death, date of last tumor assessment used. For participants who had no on-study tumor assessments \& were still alive, date of randomization used.
| months | All Participants |
|---|---|
| Median Number of Months of Progression-free Survival (PFS) (Kaplan Meier Method) | 32.0 (29.8 to NA) |
Overall survival was defined as the median number of months from baseline to death from any cause.
| months | All Participants |
|---|---|
| Median Number of Months of Overall Survival (OS) (Kaplan Meier Method) | NA (52.8 to NA) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants With Accelerated Phase CML | — | 3/5 (60%) | 5/5 (100%) |
| Participants With Chronic Myelogenous Leukemia(CML);QD Dosing | — | 10/22 (45.5%) | 21/22 (95.5%) |
| Participants With CML; BID Dosing | — | 9/15 (60%) | 15/15 (100%) |
| Participants With Myeloid Blast Phase CML | — | 3/4 (75%) | 4/4 (100%) |
| Event | Participants With Accelerated Phase CML | Participants With Chronic Myelogenous Leukemia(CML);QD Dosing | Participants With CML; BID Dosing | Participants With Myeloid Blast Phase CML |
|---|---|---|---|---|
| CARDIO-RESPIRATORY ARRESTCardiac disorders | 0/5 | 0/22 | 0/15 | 1/4 |
| PNEUMONIAInfections and infestations | 0/5 | 3/22 | 2/15 | 1/4 |
| HERPES ZOSTER DISSEMINATEDInfections and infestations | 0/5 | 0/22 | 0/15 | 1/4 |
| HERNIAGeneral disorders | 0/5 | 0/22 | 0/15 | 1/4 |
| BASAL CELL CARCINOMANeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/5 | 0/22 | 0/15 | 1/4 |
| PERICARDIAL EFFUSIONCardiac disorders | 1/5 | 0/22 | 0/15 | 0/4 |
| HAEMORRHAGE INTRACRANIALNervous system disorders | 1/5 | 0/22 | 0/15 | 0/4 |
| PLEURAL EFFUSIONRespiratory, thoracic and mediastinal disorders | 1/5 | 1/22 | 2/15 | 0/4 |
| BLAST CELL PROLIFERATIONNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/5 | 0/22 | 0/15 | 0/4 |
| TRANSITIONAL CELL CARCINOMANeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/5 | 0/22 | 0/15 | 0/4 |
| Event | Participants With Accelerated Phase CML | Participants With Chronic Myelogenous Leukemia(CML);QD Dosing | Participants With CML; BID Dosing | Participants With Myeloid Blast Phase CML |
|---|---|---|---|---|
| FATIGUEGeneral disorders | 1/5 | 10/22 | 3/15 | 2/4 |
| OEDEMA PERIPHERALGeneral disorders | 1/5 | 4/22 | 1/15 | 2/4 |
| PLEURAL EFFUSIONRespiratory, thoracic and mediastinal disorders | 2/5 | 6/22 | 5/15 | 1/4 |
| PULMONARY HYPERTENSIONRespiratory, thoracic and mediastinal disorders | 2/5 | 0/22 | 0/15 | 0/4 |
| PNEUMONIAInfections and infestations | 0/5 | 6/22 | 0/15 | 0/4 |
| DYSPNOEARespiratory, thoracic and mediastinal disorders | 1/5 | 6/22 | 3/15 | 0/4 |
| HEADACHENervous system disorders | 1/5 | 1/22 | 4/15 | 0/4 |
| NAUSEAGastrointestinal disorders | 1/5 | 1/22 | 4/15 | 0/4 |
| OCULAR HYPERAEMIAEye disorders | 0/5 | 0/22 | 0/15 | 1/4 |
| CARDIAC DISORDERCardiac disorders | 0/5 | 0/22 | 0/15 | 1/4 |
| Age Continuous(years) | Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry | CML: BID Dosing at Study Entry | Accelerated Phase CML: BID Dosing at Study Entry | Myeloid Blast Phase CML: BID Dosing at Study Entry | Total |
|---|---|---|---|---|---|
| Median | 58 (41 to 81) | 68 (30 to 80) | 63 (51 to 74) | 51 (34 to 62) | 64 (30 to 81) |
| Age, Customized(participants) | Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry | CML: BID Dosing at Study Entry | Accelerated Phase CML: BID Dosing at Study Entry | Myeloid Blast Phase CML: BID Dosing at Study Entry | Total |
|---|---|---|---|---|---|
| < 65 years | 12 | 5 | 3 | 4 | 24 |
| >= 65 years | 10 | 10 | 2 | 0 | 22 |
| Sex: Female, Male(Participants) | Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry | CML: BID Dosing at Study Entry | Accelerated Phase CML: BID Dosing at Study Entry | Myeloid Blast Phase CML: BID Dosing at Study Entry | Total |
|---|---|---|---|---|---|
| Female | 11 | 7 | 4 | 1 | 23 |
| Male | 11 | 8 | 1 | 3 | 23 |
| Race/Ethnicity, Customized(participants) | Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry | CML: BID Dosing at Study Entry | Accelerated Phase CML: BID Dosing at Study Entry | Myeloid Blast Phase CML: BID Dosing at Study Entry | Total |
|---|---|---|---|---|---|
| Caucasian | 18 | 11 | 3 | 3 | 35 |
| Black/African American | 2 | 3 | 1 | 0 | 6 |
| Asian | 0 | 1 | 0 | 0 | 1 |
| Other races | 2 | 0 | 1 | 1 | 4 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)(participants) | Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry | CML: BID Dosing at Study Entry | Accelerated Phase CML: BID Dosing at Study Entry | Myeloid Blast Phase CML: BID Dosing at Study Entry | Total |
|---|---|---|---|---|---|
| 0 = fully active | 18 | 13 | 3 | 4 | 38 |
| 1 = restricted physically strenuous activity | 4 | 1 | 2 | 0 | 7 |
| 2 = ambulatory but unable to work | 0 | 0 | 0 | 0 | 0 |
| 3 = capable of only limited self care | 0 | 0 | 0 | 0 | 0 |
| 4 = completely disabled | 0 | 0 | 0 | 0 | 0 |
| 5 = dead | 0 | 0 | 0 | 0 | 0 |
| Not reported | 0 | 1 | 0 | 0 | 1 |
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