NCT00123487 · STUDY IN CONTEXT

Advanced 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

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

MaHR defined by either complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR defined as: white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥ 1,000/mm\^3; platelets ≥ 100,000/mm\^3; no blasts or promyelocytes in peripheral blood (PB); bone marrow (BM) blasts ≤ 5%; \<5% myelocytes plus metamyelocytes in PB; basophils in PB \< 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm\^3 and \< 100,000/mm\^3; ANC \> 500/mm\^3 and \<1,000/mm\^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule. Percentage: number of participants with MaHR/number of randomized participants.

Participants were analyzed based on the treatment they were randomized to receive (not what they actually received). 95% exact confidence interval (CI) presented.

→

secondary · POSTED

A MaHR was defined as a participant having either CHR or NEL. CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm\^3; - platelets ≥ 100,000/mm\^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; \< 5% myelocytes plus metamyelocytes in PB; basophils in PB \< 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (both lower limits had to be satisfied): platelets ≥ 20,000/mm\^3 and \< 100,000/mm\^3; ANC \> 500/mm\^3 and \<1,000/mm\^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule. Percent: number of participants with MaHR /number of participants randomized.

Participants were analyzed based on the treatment they were randomized to receive.

→

secondary · POSTED

MaHR was defined by either complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR defined as: white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥ 1,000/mm\^3; platelets ≥ 100,000/mm\^3; no blasts or promyelocytes in peripheral blood (PB); bone marrow (BM) blasts ≤ 5%; \<5% myelocytes plus metamyelocytes in PB; basophils in PB \< 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by same criteria as CHR except that platelets and ANC had to satisfy at least one parameter of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm\^3 and \< 100,000/mm\^3; ANC \> 500/mm\^3 and \<1,000/mm\^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule.. Percentage: participants with MaHR/randomized participants.

Participants were analyzed based on the treatment they were randomized to receive. n=number of participants in disease group.

→

secondary · POSTED

A participants' time to MaHR was defined as the time from the first dosing date until criteria are first met for CHR or NEL, whichever occurred first. Non-responders were censored at the maximum of the date of last hematologic or cytogenetic assessment. Median time was measured in months.

Participants were analyzed based on the treatment they were randomized to receive.

→

secondary · POSTED

MaHR was defined by either CHR or no evidence of leukemia NEL. CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm\^3; - platelets ≥ 100,000/mm\^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; \< 5% myelocytes plus metamyelocytes in PB; basophils in PB \< 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm\^3 and \< 100,000/mm\^3; ANC \> 500/mm\^3 and \<1,000/mm\^3. Median duration was measured in months.

Participants who achieved a MaHR during the study.

→

secondary · POSTED

Overall Hematologic Response (OHR) was defined as CHR, NEL or minor hematologic response (MiHR). CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm\^3; - platelets ≥ 100,000/mm\^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; \< 5% myelocytes plus metamyelocytes in PB; basophils in PB \< 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm\^3 and \< 100,000/mm\^3; ANC \> 500/mm\^3 and \<1,000/mm\^3. MiHR defined as: \< 15% blasts in BM and in PB; \< 30% blasts + promyelocytes in BM and PB; \< 20% basophils in PB; No extra-medullary disease other than spleen and liver. Percentage: participants with OHR/ randomized participants.

Participants were analyzed based on the treatment they were randomized to receive.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

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-acute-lymphoblastic-leukemia
nct id: NCT00123487
trial label: Advanced 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: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia
nct id
NCT00123487
outcome key
om-0000
source section id
NCT00123487-om-0000
source outcome index
0
endpoint
Percent of Participants With Major Hematologic Response (MaHR) With 6 Months of Follow-up From Date of Last Enrollment - Randomized Population
endpoint definition
MaHR defined by either complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR defined as: white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥ 1,000/mm\^3; platelets ≥ 100,000/mm\^3; no blasts or promyelocytes in peripheral blood (PB); bone marrow (BM) blasts ≤ 5%; \<5% myelocytes plus metamyelocytes in PB; basophils in PB \< 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm\^3 and \< 100,000/mm\^3; ANC \> 500/mm\^3 and \<1,000/mm\^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule. Percentage: number of participants with MaHR/number of randomized participants.
time origin
Randomization up to 6 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Participants were analyzed based on the treatment they were randomized to receive (not what they actually received). 95% exact confidence interval (CI) presented.
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-acute-lymphoblastic-leukemia
nct id
NCT00123487
outcome key
om-0001
source section id
NCT00123487-om-0001
source outcome index
1
endpoint
Percent of Participants With Major Hematological Response (MaHR) With 2 Years of Follow-up From Date of Last Enrollment - Randomized Population
endpoint definition
A MaHR was defined as a participant having either CHR or NEL. CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm\^3; - platelets ≥ 100,000/mm\^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; \< 5% myelocytes plus metamyelocytes in PB; basophils in PB \< 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (both lower limits had to be satisfied): platelets ≥ 20,000/mm\^3 and \< 100,000/mm\^3; ANC \> 500/mm\^3 and \<1,000/mm\^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule. Percent: number of participants with MaHR /number of participants randomized.
time origin
Randomization up to 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants were analyzed based on the treatment they were randomized to receive.
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-acute-lymphoblastic-leukemia
nct id
NCT00123487
outcome key
om-0002
source section id
NCT00123487-om-0002
source outcome index
2
endpoint
Percent of Participants With Major Hematologic Response (MaHR) by Disease Group - Randomized Population
endpoint definition
MaHR was defined by either complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR defined as: white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥ 1,000/mm\^3; platelets ≥ 100,000/mm\^3; no blasts or promyelocytes in peripheral blood (PB); bone marrow (BM) blasts ≤ 5%; \<5% myelocytes plus metamyelocytes in PB; basophils in PB \< 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by same criteria as CHR except that platelets and ANC had to satisfy at least one parameter of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm\^3 and \< 100,000/mm\^3; ANC \> 500/mm\^3 and \<1,000/mm\^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule.. Percentage: participants with MaHR/randomized participants.
time origin
Randomization up to 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants were analyzed based on the treatment they were randomized to receive. n=number of participants in disease group.
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-acute-lymphoblastic-leukemia
nct id
NCT00123487
outcome key
om-0003
source section id
NCT00123487-om-0003
source outcome index
3
endpoint
Median Time to Major Hematologic Response (MaHR) - Randomized Population
endpoint definition
A participants' time to MaHR was defined as the time from the first dosing date until criteria are first met for CHR or NEL, whichever occurred first. Non-responders were censored at the maximum of the date of last hematologic or cytogenetic assessment. Median time was measured in months.
time origin
Day 1 up to 6 months (time of primary endpoint), 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants were analyzed based on the treatment they were randomized to receive.
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-acute-lymphoblastic-leukemia
nct id
NCT00123487
outcome key
om-0004
source section id
NCT00123487-om-0004
source outcome index
4
endpoint
Median Duration of a Major Hematologic Response (MaHR) in Those Participants Who Achieved a MaHR During the Study
endpoint definition
MaHR was defined by either CHR or no evidence of leukemia NEL. CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm\^3; - platelets ≥ 100,000/mm\^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; \< 5% myelocytes plus metamyelocytes in PB; basophils in PB \< 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm\^3 and \< 100,000/mm\^3; ANC \> 500/mm\^3 and \<1,000/mm\^3. Median duration was measured in months.
time origin
Day 1 up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants who achieved a MaHR during the study.
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-acute-lymphoblastic-leukemia
nct id
NCT00123487
outcome key
om-0005
source section id
NCT00123487-om-0005
source outcome index
5
endpoint
Percent of Participants With Overall Hematologic Response - Randomized Population
endpoint definition
Overall Hematologic Response (OHR) was defined as CHR, NEL or minor hematologic response (MiHR). CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm\^3; - platelets ≥ 100,000/mm\^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; \< 5% myelocytes plus metamyelocytes in PB; basophils in PB \< 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm\^3 and \< 100,000/mm\^3; ANC \> 500/mm\^3 and \<1,000/mm\^3. MiHR defined as: \< 15% blasts in BM and in PB; \< 30% blasts + promyelocytes in BM and PB; \< 20% basophils in PB; No extra-medullary disease other than spleen and liver. Percentage: participants with OHR/ randomized participants.
time origin
Randomization up to 6 Months, 2 Years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants were analyzed based on the treatment they were randomized to receive.
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-acute-lymphoblastic-leukemia
nct id
NCT00123487
outcome key
om-0000
arm key
OG000
arm label
Dasatinib 140 mg QD
regimen
Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
analyzed count
306
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00123487-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia
nct id
NCT00123487
outcome key
om-0000
arm key
OG001
arm label
Dasatinib 70 mg BID
regimen
Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
analyzed count
305
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00123487-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia
nct id
NCT00123487
outcome key
om-0001
arm key
OG000
arm label
Dasatinib 140 mg QD
regimen
Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
analyzed count
306
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00123487-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia
nct id
NCT00123487
outcome key
om-0001
arm key
OG001
arm label
Dasatinib 70 mg BID
regimen
Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
analyzed count
305
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00123487-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia
nct id
NCT00123487
outcome key
om-0002
arm key
OG000
arm label
Dasatinib 140 mg QD
regimen
Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
analyzed count
306
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00123487-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia
nct id
NCT00123487
outcome key
om-0002
arm key
OG001
arm label
Dasatinib 70 mg BID
regimen
Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
analyzed count
305
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00123487-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia
nct id
NCT00123487
outcome key
om-0003
arm key
OG000
arm label
Dasatinib 140 mg QD
regimen
Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
analyzed count
306
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00123487-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia
nct id
NCT00123487
outcome key
om-0003
arm key
OG001
arm label
Dasatinib 70 mg BID
regimen
Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
analyzed count
305
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00123487-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia
nct id
NCT00123487
outcome key
om-0004
arm key
OG000
arm label
Dasatinib 140 mg QD
regimen
Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
analyzed count
156
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00123487-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia
nct id
NCT00123487
outcome key
om-0004
arm key
OG001
arm label
Dasatinib 70 mg BID
regimen
Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
analyzed count
153
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00123487-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia
nct id
NCT00123487
outcome key
om-0005
arm key
OG000
arm label
Dasatinib 140 mg QD
regimen
Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
analyzed count
306
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00123487-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia
nct id
NCT00123487
outcome key
om-0005
arm key
OG001
arm label
Dasatinib 70 mg BID
regimen
Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
analyzed count
305
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00123487-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia
nct id
NCT00123487
harm key
EG000
source section id
NCT00123487-ae
event group key
EG000
event group label
Dasatinib 140 mg QD
serious affected
228
serious at risk
304
other affected
289
other at risk
304
frequency threshold
5
collection period
Day 1 up to 7 years
event definition
Participants who received at least one dose of study drug were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.
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-acute-lymphoblastic-leukemia
nct id
NCT00123487
harm key
EG001
source section id
NCT00123487-ae
event group key
EG001
event group label
Dasatinib 70 mg BID
serious affected
236
serious at risk
305
other affected
290
other at risk
305
frequency threshold
5
collection period
Day 1 up to 7 years
event definition
Participants who received at least one dose of study drug were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.
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