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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
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Details: 11/6/2008 to 9/1/2010. All recruitment done at UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 27 participants registered, two were found ineligible and did not participate in the study.

Reporting Groups
Bendamustine Starting dose 50 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.

Participant Flow:   Overall Study

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Bendamustine Starting dose 50 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (22 to 88) 
[Units: Participants]
Female   9 
Male   16 
Region of Enrollment 
[Units: Participants]
United States   25 

  Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD)   [ Time Frame: During course 1 (4 week cycle) ]

2.  Secondary:   Number of Participants With a Response   [ Time Frame: 1 - 24 week cycles (up to 8 weeks) ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

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
e-mail: eharriso@mdanderson.org

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