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Bendamustine in Acute Leukemia and MDS

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ClinicalTrials.gov Identifier: NCT00790855
Recruitment Status : Terminated (Lack of Response)
First Posted : November 14, 2008
Results First Posted : October 19, 2012
Last Update Posted : December 4, 2012
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Myeloid Leukemia
Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia
Chronic Myeloid Leukemia
Intervention Drug: Bendamustine
Enrollment 27
Recruitment Details Recruitment Details: 11/6/2008 to 9/1/2010. All recruitment done at UT MD Anderson Cancer Center.
Pre-assignment Details Out of 27 participants registered, two were found ineligible and did not participate in the study.
Arm/Group Title Bendamustine
Hide Arm/Group Description Starting dose 50 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
Period Title: Overall Study
Started 25
Completed 25
Not Completed 0
Arm/Group Title Bendamustine
Hide Arm/Group Description Starting dose 50 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants
57
(22 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
9
  36.0%
Male
16
  64.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
1.Primary Outcome
Title Maximum Tolerated Dose (MTD)
Hide Description 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.
Time Frame During course 1 (4 week cycle)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bendamustine
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: mg/m^2
75
2.Secondary Outcome
Title Number of Participants With a Response
Hide Description 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.
Time Frame 1 - 24 week cycles (up to 8 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bendamustine (75 mg/m^2)
Hide Arm/Group Description:
75 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
Complete Response 0
Partial Response 0
Marrow Complete Response 1
Time Frame 3 years 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bendamustine
Hide Arm/Group Description Starting dose 50 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
All-Cause Mortality
Bendamustine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bendamustine
Affected / at Risk (%) # Events
Total   3/25 (12.00%)    
General disorders   
Death  1  1/25 (4.00%)  1
Nervous system disorders   
Seizures  1  1/25 (4.00%)  1
Renal and urinary disorders   
Acute Renal Failure  1  2/25 (8.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bendamustine
Affected / at Risk (%) # Events
Total   11/25 (44.00%)    
Gastrointestinal disorders   
Nausea/Vomiting  1  11/25 (44.00%)  11
Diarrhea  1  7/25 (28.00%)  7
Metabolism and nutrition disorders   
Liver function abnormality  1  5/25 (20.00%)  5
Renal and urinary disorders   
Elevated Creatinine  1  11/25 (44.00%)  11
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Hagop M. Kantarjian, M.D.
Organization: The University of MD Anderson Cancer Center
Phone: 713-792-7026
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00790855     History of Changes
Other Study ID Numbers: 2007-0634
First Submitted: November 13, 2008
First Posted: November 14, 2008
Results First Submitted: June 22, 2012
Results First Posted: October 19, 2012
Last Update Posted: December 4, 2012