TriangleNCT00123474 · STUDY IN CONTEXT
Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
Cytogenetic response (CyR) was based on the number of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): \>0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: \>35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: \>65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: \>95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Baseline=closest to, but no later than, the first day of study drug for treated participants and closest to, but no later than, the date of randomization, for those who were randomized but who never received treatment, unless otherwise specified.
CyR was based on the number of Ph+ metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: CCyR: 0% Ph+ cells in metaphase in BM; PCyR: \>0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: \>35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: \>65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: \>95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of CCyR or PCyR. Baseline=closest to, but no later than, the first day of study drug for treated participants and closest to, but no later than, the date of randomization, for those who were randomized but who never received treatment, unless otherwise specified.
A complete hematologic response (CHR) was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets \< 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); \< 5% myelocytes plus metamyelocytes in PB; Basophils in PB \< 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date.
Time to MCyR was defined as the time from the first dosing date until criteria were first met for CCyR or PCyR, whichever occurred first. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to MCyR response for responders and time to last cytogenetic assessment for non-responders).
Time to CHR was defined as the time from the first dosing date until criteria are first met for the response. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to CHR response for responders and time to last hematologic assessment for non-responders).
Time to MCyR was defined as the time from the first dosing date until criteria were first met for CCyR or PCyR, whichever occurred first. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to MCyR response for responders and time to last cytogenetic assessment for non-responders). Cytogenetic assessments were not done after the 2 Year Follow-up.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00123474
- trial label
- Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 4
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00123474
- outcome key
- om-0000
- source section id
- NCT00123474-om-0000
- source outcome index
- 0
- endpoint
- Percent of Participants With Major Cytogenetic Response (MCyR) at 6 Months Follow-Up
- endpoint definition
- Cytogenetic response (CyR) was based on the number of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): \>0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: \>35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: \>65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: \>95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Baseline=closest to, but no later than, the first day of study drug for treated participants and closest to, but no later than, the date of randomization, for those who were randomized but who never received treatment, unless otherwise specified.
- time origin
- 6 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized imatinib-resistant participants with available data were summarized.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00123474
- outcome key
- om-0001
- source section id
- NCT00123474-om-0001
- source outcome index
- 1
- endpoint
- Percent of Participants With MCyR At or Prior to 24 Months Follow-Up
- endpoint definition
- CyR was based on the number of Ph+ metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: CCyR: 0% Ph+ cells in metaphase in BM; PCyR: \>0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: \>35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: \>65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: \>95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of CCyR or PCyR. Baseline=closest to, but no later than, the first day of study drug for treated participants and closest to, but no later than, the date of randomization, for those who were randomized but who never received treatment, unless otherwise specified.
- time origin
- 24 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized imatinib-resistant participants with available data were summarized.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00123474
- outcome key
- om-0002
- source section id
- NCT00123474-om-0002
- source outcome index
- 2
- endpoint
- Percent of Participants With Complete Hematologic Response (CHR) at 6 and 24 Months Follow-Up
- endpoint definition
- A complete hematologic response (CHR) was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets \< 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); \< 5% myelocytes plus metamyelocytes in PB; Basophils in PB \< 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date.
- time origin
- 6 months, 24 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized imatinib-resistant participants with available data were summarized.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00123474
- outcome key
- om-0003
- source section id
- NCT00123474-om-0003
- source outcome index
- 3
- endpoint
- Time to MCyR in Participants With MCyR at 6 Months Follow-Up
- endpoint definition
- Time to MCyR was defined as the time from the first dosing date until criteria were first met for CCyR or PCyR, whichever occurred first. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to MCyR response for responders and time to last cytogenetic assessment for non-responders).
- time origin
- 6 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Randomized imatinib-resistant participants with MCyR and available data were summarized.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00123474
- outcome key
- om-0004
- source section id
- NCT00123474-om-0004
- source outcome index
- 4
- endpoint
- Time to CHR in Participants With CHR at 6 Months Follow-Up
- endpoint definition
- Time to CHR was defined as the time from the first dosing date until criteria are first met for the response. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to CHR response for responders and time to last hematologic assessment for non-responders).
- time origin
- 6 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Randomized imatinib-resistant participants with CHR and available data were summarized.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00123474
- outcome key
- om-0005
- source section id
- NCT00123474-om-0005
- source outcome index
- 5
- endpoint
- Time to MCyR in Participants With MCyR at 24 Months Follow-Up
- endpoint definition
- Time to MCyR was defined as the time from the first dosing date until criteria were first met for CCyR or PCyR, whichever occurred first. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to MCyR response for responders and time to last cytogenetic assessment for non-responders). Cytogenetic assessments were not done after the 2 Year Follow-up.
- time origin
- 24 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Randomized imatinib-resistant participants with MCyR were summarized.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00123474
- outcome key
- om-0000
- arm key
- OG000
- arm label
- QD Dasatinib
- regimen
- Participants received either 100 mg or 140 mg once a day (QD) dasatinib until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
- analyzed count
- 247
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00123474-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00123474
- outcome key
- om-0000
- arm key
- OG001
- arm label
- BID Dasatinib
- regimen
- Participants received either 50 mg or 70 mg twice a day (BID) dasatinib until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
- analyzed count
- 251
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00123474-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00123474
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Dasatinib QD
- regimen
- Participants received either 100 mg QD or 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
- analyzed count
- 247
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00123474-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00123474
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Dasatinib BID
- regimen
- Participants received either 50 mg BID or 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
- analyzed count
- 250
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00123474-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00123474
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Dasatinib 100 mg Total Daily Dose
- regimen
- Participants received 100 mg as a total daily dose (either 50 mg BID or 100 mg QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
- analyzed count
- 248
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00123474-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00123474
- outcome key
- om-0001
- arm key
- OG003
- arm label
- Dasatinib 140 mg Total Daily Dose
- regimen
- Participants received 140 mg as a total daily dose (either 70 mg BID or 140 mg QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
- analyzed count
- 249
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00123474-om-0001#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00123474
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Dasatinib 100 mg QD
- regimen
- Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
- analyzed count
- 124
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00123474-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00123474
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Dasatinib 140 mg QD
- regimen
- Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
- analyzed count
- 123
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00123474-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00123474
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Dasatinib 50 mg BID
- regimen
- Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
- analyzed count
- 124
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00123474-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00123474
- outcome key
- om-0002
- arm key
- OG003
- arm label
- Dasatinib 70 mg BID
- regimen
- Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
- analyzed count
- 127
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00123474-om-0002#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00123474
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Dasatinib 100 mg QD
- regimen
- Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
- analyzed count
- 66
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00123474-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00123474
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Dasatinib 140 mg QD
- regimen
- Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
- analyzed count
- 62
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00123474-om-0003#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00123474
- harm key
- EG000
- source section id
- NCT00123474-ae
- event group key
- EG000
- event group label
- 100mg QD
- serious affected
- 75
- serious at risk
- 165
- other affected
- 160
- other at risk
- 165
- frequency threshold
- 5
- collection period
- Baseline to 30 days post last dose, up to 7 years (study closure July 2014)
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00123474
- harm key
- EG001
- source section id
- NCT00123474-ae
- event group key
- EG001
- event group label
- 140mg QD
- serious affected
- 78
- serious at risk
- 163
- other affected
- 155
- other at risk
- 163
- frequency threshold
- 5
- collection period
- Baseline to 30 days post last dose, up to 7 years (study closure July 2014)
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00123474
- harm key
- EG002
- source section id
- NCT00123474-ae
- event group key
- EG002
- event group label
- 50mg BID
- serious affected
- 89
- serious at risk
- 167
- other affected
- 160
- other at risk
- 167
- frequency threshold
- 5
- collection period
- Baseline to 30 days post last dose, up to 7 years (study closure July 2014)
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00123474
- harm key
- EG003
- source section id
- NCT00123474-ae
- event group key
- EG003
- event group label
- 70mg BID
- serious affected
- 92
- serious at risk
- 167
- other affected
- 165
- other at risk
- 167
- frequency threshold
- 5
- collection period
- Baseline to 30 days post last dose, up to 7 years (study closure July 2014)
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice