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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)
Hide 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)
Hide 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
Layout table for Results Point of Contact information
Name/Title: Hagop M. Kantarjian, M.D.
Organization: The University of MD Anderson Cancer Center
Phone: 713-792-7026
EMail: eharriso@mdanderson.org
Layout table for additonal information
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