Trial Outcomes & Findings for Dasatinib as Therapy for Myeloproliferative Disorders (MPDs) (NCT NCT00255346)
NCT ID: NCT00255346
Last Updated: 2025-12-30
Results Overview
Response Rate is complete response plus partial response (CR+PR) for each disease category. Response Evaluation Criteria are as follows: Systemic Mastocytosis (SM): CR is the improvement of C-Findings, Tryptase \<20, and no organomegaly. PR is the improvement of C-Findings. Acute Myeloid Leukemia (AML)/MDS and CMML: CR is bone marrow blasts \</= 5%, absolute neutrophil count (ANC) \>/= 1000 and platelets \>/= 100. PR is bone marrow blasts 6-25% but decreased by \> 50% and absolute neutrophil count, absolute neutrophil count (ANC) \>/= 1000 and platelets \>/= 100. Primary Myelofibrosis (PMF): CR is bone marrow blasts \</= 5%, absolute neutrophil count (ANC) \>/= 1000 and platelets \>/= 100. CR is PR plus one or more of the following: ANC \>/= 1000, decreased platelets by 50%, hemoglobin increase of 2g/dl or reduction splenomegaly and/or hepatomegaly by 50%. HES/CEL: CR is disappearance of eosinophilia \</= 10%, PR is reduction of eosinophilia by \>/= 50%
COMPLETED
PHASE2
68 participants
Baseline to completion of 4 week cycle or until disease progression
2025-12-30
Participant Flow
Sixty-Seven participants were registered and received the study medication for this study.
Participant milestones
| Measure |
Acute Myeloid Leukemia (AML)
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
MDS/CMML
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
HES/CEL
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
Primary Myelofibrosis (PMF)
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
Systemic Mastocytosis (SM)
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
8
|
11
|
33
|
|
Overall Study
COMPLETED
|
9
|
6
|
8
|
11
|
33
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Acute Myeloid Leukemia (AML)
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
MDS/CMML
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
HES/CEL
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
Primary Myelofibrosis (PMF)
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
Systemic Mastocytosis (SM)
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Dasatinib as Therapy for Myeloproliferative Disorders (MPDs)
Baseline characteristics by cohort
| Measure |
Primary Myelofibrosis (PMF)
n=11 Participants
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
Systemic Mastocytosis (SM)
n=33 Participants
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
Total
n=68 Participants
Total of all reporting groups
|
MDS/CMML
n=6 Participants
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
HES/CEL
n=8 Participants
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
Acute Myeloid Leukemia (AML)
n=10 Participants
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=174 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=164 Participants
|
28 Participants
n=671 Participants
|
46 Participants
n=77 Participants
|
2 Participants
n=166 Participants
|
5 Participants
n=167 Participants
|
3 Participants
n=174 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=164 Participants
|
5 Participants
n=671 Participants
|
22 Participants
n=77 Participants
|
4 Participants
n=166 Participants
|
3 Participants
n=167 Participants
|
7 Participants
n=174 Participants
|
|
Age, Continuous
|
63 years
n=164 Participants
|
57 years
n=671 Participants
|
62 years
n=77 Participants
|
68 years
n=166 Participants
|
62 years
n=167 Participants
|
70 years
n=174 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=164 Participants
|
19 Participants
n=671 Participants
|
28 Participants
n=77 Participants
|
2 Participants
n=166 Participants
|
3 Participants
n=167 Participants
|
3 Participants
n=174 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=164 Participants
|
14 Participants
n=671 Participants
|
40 Participants
n=77 Participants
|
4 Participants
n=166 Participants
|
5 Participants
n=167 Participants
|
7 Participants
n=174 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=174 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=174 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=174 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=164 Participants
|
1 Participants
n=671 Participants
|
1 Participants
n=77 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=174 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=164 Participants
|
31 Participants
n=671 Participants
|
66 Participants
n=77 Participants
|
6 Participants
n=166 Participants
|
8 Participants
n=167 Participants
|
10 Participants
n=174 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=174 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=164 Participants
|
1 Participants
n=671 Participants
|
1 Participants
n=77 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=174 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=164 Participants
|
33 participants
n=671 Participants
|
67 participants
n=77 Participants
|
6 participants
n=166 Participants
|
8 participants
n=167 Participants
|
9 participants
n=174 Participants
|
PRIMARY outcome
Timeframe: Baseline to completion of 4 week cycle or until disease progressionResponse Rate is complete response plus partial response (CR+PR) for each disease category. Response Evaluation Criteria are as follows: Systemic Mastocytosis (SM): CR is the improvement of C-Findings, Tryptase \<20, and no organomegaly. PR is the improvement of C-Findings. Acute Myeloid Leukemia (AML)/MDS and CMML: CR is bone marrow blasts \</= 5%, absolute neutrophil count (ANC) \>/= 1000 and platelets \>/= 100. PR is bone marrow blasts 6-25% but decreased by \> 50% and absolute neutrophil count, absolute neutrophil count (ANC) \>/= 1000 and platelets \>/= 100. Primary Myelofibrosis (PMF): CR is bone marrow blasts \</= 5%, absolute neutrophil count (ANC) \>/= 1000 and platelets \>/= 100. CR is PR plus one or more of the following: ANC \>/= 1000, decreased platelets by 50%, hemoglobin increase of 2g/dl or reduction splenomegaly and/or hepatomegaly by 50%. HES/CEL: CR is disappearance of eosinophilia \</= 10%, PR is reduction of eosinophilia by \>/= 50%
Outcome measures
| Measure |
Acute Myeloid Leukemia (AML)
n=9 Participants
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
MDS/CMML
n=6 Participants
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
HES/CEL
n=8 Participants
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
Primary Myelofibrosis (PMF)
n=11 Participants
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
Systemic Mastocytosis (SM)
n=33 Participants
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
|---|---|---|---|---|---|
|
Participant Response Rate
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, once a week for a month, thereafter monthly, up to 10 yearsPopulation: The number of participants analyzed for duration of response reflects the number of participants with a response for each arm.
Response date to loss of response or last follow up.
Outcome measures
| Measure |
Acute Myeloid Leukemia (AML)
n=1 Participants
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
MDS/CMML
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
HES/CEL
n=1 Participants
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
Primary Myelofibrosis (PMF)
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
Systemic Mastocytosis (SM)
n=2 Participants
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
|---|---|---|---|---|---|
|
Duration of Response (Survival)
|
NA Months
The duration of response cannot be reported for a single participant for privacy reasons
|
—
|
NA Months
The duration of response cannot be reported for a single participant for privacy reasons
|
—
|
13 Months
Interval 8.0 to 18.0
|
Adverse Events
Dasatinib All Patient Groups
Serious adverse events
| Measure |
Dasatinib All Patient Groups
n=68 participants at risk
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
|---|---|
|
Blood and lymphatic system disorders
Hemorrhage CNS
|
1.5%
1/68 • Number of events 1 • Through study completion, up to 10 years
|
|
Infections and infestations
Skin Infection
|
1.5%
1/68 • Number of events 1 • Through study completion, up to 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.5%
1/68 • Number of events 1 • Through study completion, up to 10 years
|
|
Cardiac disorders
Pericardial Effusion
|
1.5%
1/68 • Number of events 1 • Through study completion, up to 10 years
|
Other adverse events
| Measure |
Dasatinib All Patient Groups
n=68 participants at risk
Dasatinib 70 mg orally twice daily.
Dasatinib (BMS-354825): 70 mg orally twice daily
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.5%
18/68 • Number of events 18 • Through study completion, up to 10 years
|
|
Blood and lymphatic system disorders
Edema
|
7.4%
5/68 • Number of events 5 • Through study completion, up to 10 years
|
|
General disorders
Fatigue
|
11.8%
8/68 • Number of events 8 • Through study completion, up to 10 years
|
|
General disorders
Headache
|
17.6%
12/68 • Number of events 12 • Through study completion, up to 10 years
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
30.9%
21/68 • Number of events 21 • Through study completion, up to 10 years
|
|
General disorders
Pain
|
10.3%
7/68 • Number of events 7 • Through study completion, up to 10 years
|
|
Blood and lymphatic system disorders
Platelets/Hemoglobin
|
8.8%
6/68 • Number of events 6 • Through study completion, up to 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
20.6%
14/68 • Number of events 14 • Through study completion, up to 10 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
4/68 • Number of events 4 • Through study completion, up to 10 years
|
|
Gastrointestinal disorders
Diarrhea
|
7.4%
5/68 • Number of events 5 • Through study completion, up to 10 years
|
Additional Information
Hagop Kantarjian, MD/Department Chair
The University of Texas MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place