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Multi-center Study of Myeloablative Allo Stem Cell Transplant for Non-remission AML Using CloBu4 Regimen (CloBu4)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Genzyme, a Sanofi Company
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT01457885
First received: October 19, 2011
Last updated: June 14, 2016
Last verified: June 2016
Results First Received: June 14, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Myeloblastic Leukemia
Interventions: Drug: Clofarabine/Busulfan x 4
Procedure: Peripheral blood stem cell transplant

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
75 Patients were enrolled. Only 74 began treatment. 3 of these patients were pediatric and were left off the subsequent analysis.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
CloBu4 Regimen

After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant

Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days


Participant Flow:   Overall Study
    CloBu4 Regimen  
STARTED     74  
COMPLETED     74  
NOT COMPLETED     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.
75 patients were enrolled. Only 74 patients were treated. Of the treated patients, 3 were pediatric and were left off of the analysis. 71 adult patients were analyzed.

Reporting Groups
  Description
CloBu4 Regimen

After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant

Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days


Baseline Measures
    CloBu4 Regimen  
Number of Participants  
[units: participants]
  71  
Age  
[units: years]
Median (Full Range)
  56  
  (19 to 65)  
Gender  
[units: participants]
 
Female     31  
Male     40  



  Outcome Measures
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1.  Primary:   Cumulative Incidence of Non Relapse Mortality (NRM)   [ Time Frame: 1 year ]

2.  Secondary:   The Percentage of Patients Alive at 1 Year   [ Time Frame: 1 year ]

3.  Secondary:   Incidence of Relapse   [ Time Frame: 2 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. John Magenau, M.D.
Organization: University of Michigan Comprehensive Cancer Center
phone: 734-936-8785
e-mail: johnmage@umich.edu



Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT01457885     History of Changes
Other Study ID Numbers: UMCC 2011.038
Study First Received: October 19, 2011
Results First Received: June 14, 2016
Last Updated: June 14, 2016
Health Authority: United States: Institutional Review Board