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Bendamustine and Idarubicin in Treating Older Patients With Previously Untreated AML or MDS

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01141725
First Posted: June 10, 2010
Last Update Posted: August 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
Results First Submitted: March 7, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
de Novo Myelodysplastic Syndromes
Myelodysplastic Syndrome With Isolated Del(5q)
Untreated Adult Acute Myeloid Leukemia
Interventions: Drug: bendamustine hydrochloride
Drug: idarubicin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Bendamustine Dose of 45mg/m2/Day

Patients receive bendamustine hydrochloride 45mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.

Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Bendamustine Dose of 60mg/m2/Day

Patients receive bendamustine hydrochloride 60mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.

Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Bendamustine Dose of 75mg/m2/Day

Patients receive bendamustine hydrochloride 75mg/m2 IV on days 1-5 and idarubicin 12mg/m2 IV on days 1 and 2.

Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.


Participant Flow:   Overall Study
    Bendamustine Dose of 45mg/m2/Day   Bendamustine Dose of 60mg/m2/Day   Bendamustine Dose of 75mg/m2/Day
STARTED   3   33   3 
COMPLETED   3   33   3 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Treatment (Combination Chemotherapy)

Patients receive bendamustine hydrochloride IV on days 1-5 and idarubicin IV on days 1 and 2. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

bendamustine hydrochloride: Given IV

idarubicin: Given IV


Baseline Measures
   Treatment (Combination Chemotherapy) 
Overall Participants Analyzed 
[Units: Participants]
 39 
Age 
[Units: Years]
Median (Full Range)
 73 
 (56 to 82) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      24  61.5% 
Male      15  38.5% 
Region of Enrollment 
[Units: Participants]
 
United States   39 
ECOG [1] 
[Units: Participants]
Count of Participants
 
ECOG 0   0 
ECOG 1   35 
ECOG 2   4 
[1]

ECOG performance status

  • grade 0: fully active, able to carry on all pre-disease performance without restriction
  • grade 1 : restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
  • grade 2 : ambulatory and capable of all selfcare but unable to carry out any work activities, up and about more than 50% of waking hours


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Response   [ Time Frame: 6 months ]

2.  Primary:   Incidence of Greater Than or Equal to Grade 3 Toxicity   [ Time Frame: Up to day +100 after end of therapy or until the patient received an alternative treatment for leukemia, whatever happens earlier ]

3.  Primary:   Maximum Tolerated Dose   [ Time Frame: 6 months ]

4.  Primary:   Median Survival   [ Time Frame: 5 years ]

5.  Secondary:   Disease-free Survival (DFS)   [ Time Frame: 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Elihu Estey, MD, Director of AML Program
Organization: FHCRC/UWMC
phone: 206-288-7176
e-mail: eestey@uw.edu



Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01141725     History of Changes
Other Study ID Numbers: 2413.00
NCI-2010-01253 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
K12CA076930 ( U.S. NIH Grant/Contract )
First Submitted: June 9, 2010
First Posted: June 10, 2010
Results First Submitted: March 7, 2017
Results First Posted: August 18, 2017
Last Update Posted: August 18, 2017