Trial Outcomes & Findings for Treatment of Adult Ph+ LAL With BMS-354825 (NCT NCT00391989)
NCT ID: NCT00391989
Last Updated: 2017-01-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
End of the study, up to day 85
Results posted on
2017-01-04
Participant Flow
Participant milestones
| Measure |
Study Group
All patients registered in the study.
|
|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
COMPLETED
|
53
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Adult Ph+ LAL With BMS-354825
Baseline characteristics by cohort
| Measure |
Dasatinib
n=53 Participants
All patients registered in the study.
|
|---|---|
|
Age, Continuous
|
53.61 Years
n=5 Participants
|
|
Gender
Female
|
27 Participants
n=5 Participants
|
|
Gender
Male
|
26 Participants
n=5 Participants
|
|
White Blood Cells
|
18.80 *10^9 cells/L
n=5 Participants
|
PRIMARY outcome
Timeframe: End of the study, up to day 85Outcome measures
| Measure |
Study Group
n=53 Participants
All patients registered in the study.
|
|---|---|
|
Rate of Hematological Complete Remission (HCR) Obtained During the BMS Induction Treatment Within Day +85 From the Start of BMS (i.e., Whenever Achieved From the Start of the Experimental Drug).
|
53 Patients
|
SECONDARY outcome
Timeframe: End of studyOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of studyOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of studyOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of studyOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of studyOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of studyOutcome measures
Outcome data not reported
Adverse Events
Dasatinib
Serious events: 13 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dasatinib
n=53 participants at risk
All patients registered in the study.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary edema
|
1.9%
1/53 • Number of events 1 • 25 months.
Physicians reporting whenever a SAE happened.
|
|
General disorders
Weight gain
|
1.9%
1/53 • 25 months.
Physicians reporting whenever a SAE happened.
|
|
General disorders
Diarrhea
|
1.9%
1/53 • 25 months.
Physicians reporting whenever a SAE happened.
|
|
General disorders
Hypertransaminasemia
|
1.9%
1/53 • 25 months.
Physicians reporting whenever a SAE happened.
|
|
General disorders
Fever
|
1.9%
1/53 • 25 months.
Physicians reporting whenever a SAE happened.
|
|
General disorders
Proteinuria
|
1.9%
1/53 • 25 months.
Physicians reporting whenever a SAE happened.
|
|
General disorders
Increase of liver function
|
1.9%
1/53 • 25 months.
Physicians reporting whenever a SAE happened.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
1.9%
1/53 • 25 months.
Physicians reporting whenever a SAE happened.
|
|
Gastrointestinal disorders
Infection
|
1.9%
1/53 • 25 months.
Physicians reporting whenever a SAE happened.
|
|
General disorders
Mood alteration
|
1.9%
1/53 • 25 months.
Physicians reporting whenever a SAE happened.
|
|
General disorders
hyperkalemia
|
1.9%
1/53 • 25 months.
Physicians reporting whenever a SAE happened.
|
|
General disorders
Nausea
|
3.8%
2/53 • 25 months.
Physicians reporting whenever a SAE happened.
|
Other adverse events
| Measure |
Dasatinib
n=53 participants at risk
All patients registered in the study.
|
|---|---|
|
General disorders
Fever
|
1.9%
1/53 • 25 months.
Physicians reporting whenever a SAE happened.
|
|
General disorders
Weight gain
|
1.9%
1/53 • 25 months.
Physicians reporting whenever a SAE happened.
|
|
General disorders
proteinuria
|
1.9%
1/53 • 25 months.
Physicians reporting whenever a SAE happened.
|
|
General disorders
Mild increase of liver function
|
3.8%
2/53 • 25 months.
Physicians reporting whenever a SAE happened.
|
|
Gastrointestinal disorders
Gastrointestinal
|
1.9%
1/53 • 25 months.
Physicians reporting whenever a SAE happened.
|
|
General disorders
Infection
|
1.9%
1/53 • 25 months.
Physicians reporting whenever a SAE happened.
|
|
General disorders
Mood alteration
|
1.9%
1/53 • 25 months.
Physicians reporting whenever a SAE happened.
|
|
General disorders
Hyperkalemia
|
1.9%
1/53 • 25 months.
Physicians reporting whenever a SAE happened.
|
|
General disorders
Acute pulmonary edema
|
1.9%
1/53 • 25 months.
Physicians reporting whenever a SAE happened.
|
|
General disorders
Diarrhea
|
1.9%
1/53 • 25 months.
Physicians reporting whenever a SAE happened.
|
|
General disorders
Hypertransaminasemia
|
1.9%
1/53 • 25 months.
Physicians reporting whenever a SAE happened.
|
|
General disorders
Nausea
|
1.9%
1/53 • 25 months.
Physicians reporting whenever a SAE happened.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place