Trial Outcomes & Findings for Bendamustine in Acute Leukemia and MDS (NCT NCT00790855)
NCT ID: NCT00790855
Last Updated: 2012-12-04
Results Overview
The MTD is the highest dose level in which \<2 patients of 6 develop first cycle dose limiting toxicity (DLT). MTD assessed during course 1 (4 week cycle), every 3-7 days.
TERMINATED
PHASE1/PHASE2
27 participants
During course 1 (4 week cycle)
2012-12-04
Participant Flow
Recruitment Details: 11/6/2008 to 9/1/2010. All recruitment done at UT MD Anderson Cancer Center.
Out of 27 participants registered, two were found ineligible and did not participate in the study.
Participant milestones
| Measure |
Bendamustine
Starting dose 50 mg/m\^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bendamustine in Acute Leukemia and MDS
Baseline characteristics by cohort
| Measure |
Bendamustine
n=25 Participants
Starting dose 50 mg/m\^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
|
|---|---|
|
Age Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During course 1 (4 week cycle)The MTD is the highest dose level in which \<2 patients of 6 develop first cycle dose limiting toxicity (DLT). MTD assessed during course 1 (4 week cycle), every 3-7 days.
Outcome measures
| Measure |
Bendamustine
n=25 Participants
Starting dose 50 mg/m\^2 intravenously, over 2 hours twice on Days 1-4 of every 4 week study cycle, with dose escalation of 25 mg/m\^2 for 3 levels.
|
|---|---|
|
Maximum Tolerated Dose (MTD)
|
75 mg/m^2
|
SECONDARY outcome
Timeframe: 1 - 24 week cycles (up to 8 weeks)A complete response (CR) is defined as normalization of the bone marrow and peripheral blood counts with \</= 5% marrow blasts in a normo-or hypercellular marrow, with a granulocyte count of \>/= 10\^9/L and a platelet count of \>/=100 X 10\^9/L. A partial response (PR) was defined as for CR, but with only \>/=50% reduction of marrow blasts and to a range of 6%-25%. A marrow complete response was defined as a reduction of marrow blasts to \</=5% but without recovery of peripheral counts.
Outcome measures
| Measure |
Bendamustine
n=25 Participants
Starting dose 50 mg/m\^2 intravenously, over 2 hours twice on Days 1-4 of every 4 week study cycle, with dose escalation of 25 mg/m\^2 for 3 levels.
|
|---|---|
|
Number of Participants With a Response
Complete Response
|
0 participants
|
|
Number of Participants With a Response
Marrow Complete Response
|
1 participants
|
|
Number of Participants With a Response
Partial Response
|
0 participants
|
Adverse Events
Bendamustine
Serious adverse events
| Measure |
Bendamustine
n=25 participants at risk
Starting dose 50 mg/m\^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
|
|---|---|
|
General disorders
Death
|
4.0%
1/25 • Number of events 1 • 3 years 3 months
|
|
Nervous system disorders
Seizures
|
4.0%
1/25 • Number of events 1 • 3 years 3 months
|
|
Renal and urinary disorders
Acute Renal Failure
|
8.0%
2/25 • Number of events 2 • 3 years 3 months
|
Other adverse events
| Measure |
Bendamustine
n=25 participants at risk
Starting dose 50 mg/m\^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
|
|---|---|
|
Renal and urinary disorders
Elevated Creatinine
|
44.0%
11/25 • Number of events 11 • 3 years 3 months
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
44.0%
11/25 • Number of events 11 • 3 years 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
28.0%
7/25 • Number of events 7 • 3 years 3 months
|
|
Metabolism and nutrition disorders
Liver function abnormality
|
20.0%
5/25 • Number of events 5 • 3 years 3 months
|
Additional Information
Hagop M. Kantarjian, M.D.
The University of MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place