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Immunotherapy for Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Blast Phase Chronic Myelogenous Leukemia (BP CML), and Myelodysplastic Syndrome (MDS) Relapse After Allogeneic Transplantation

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Martha Arellano, Emory University
ClinicalTrials.gov Identifier:
NCT00548847
First received: October 22, 2007
Last updated: July 8, 2016
Last verified: July 2016
Results First Received: July 8, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukemia
Intervention: Drug: GM-CSF, Interferon-α-2b

  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
All patients were enrolled at the Winship Cancer Institute of Emory University. The study closed to accrual in May 2011.

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
GM-CSF, Interferon-α-2b Granulocyte-macrophage colony-stimulating factor (GM-CSF), Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m2 Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.

Participant Flow:   Overall Study
    GM-CSF, Interferon-α-2b  
STARTED     15  
COMPLETED     8  
NOT COMPLETED     7  
Disease progression                 7  



  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.
No text entered.

Reporting Groups
  Description
GM-CSF, Interferon-α-2b GM-CSF, Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m2 Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.

Baseline Measures
    GM-CSF, Interferon-α-2b  
Number of Participants  
[units: participants]
  15  
Age  
[units: participants]
 
<=18 years     1  
Between 18 and 65 years     13  
>=65 years     1  
Gender  
[units: participants]
 
Female     9  
Male     6  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     1  
Not Hispanic or Latino     13  
Unknown or Not Reported     1  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     1  
White     13  
More than one race     0  
Unknown or Not Reported     1  
Region of Enrollment  
[units: participants]
 
United States     15  



  Outcome Measures
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1.  Primary:   Efficacy of GM-CSF and Pegylated Interferon-alpha 2b When Administered to Patients With AML, ALL, Blast Phase CML, and MDS Relapse After Allogeneic Transplantation, Defined as Progression-free Survival of > 33% at 3 Months   [ Time Frame: 3 months after cytokine treatment ]

2.  Secondary:   Overall Survival at 6 Months (Evaluate Overall Responses; Perform Lab Experiments to Test Hypothesis That Exposure to Interferon-alpha and GM-CSF Up-regulates Co-stimulatory Molecule Expression on Relapsed Acute Leukemia Cells)   [ Time Frame: 6 months after cytokine treatment ]


  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: Martha Arellano, MD
Organization: Emory University
phone: 404-778-1900
e-mail: marella@emory.edu



Responsible Party: Martha Arellano, Emory University
ClinicalTrials.gov Identifier: NCT00548847     History of Changes
Other Study ID Numbers: IRB00002219
WCI1228-06 ( Other Identifier: Winship Cancer Institute of Emory University )
Study First Received: October 22, 2007
Results First Received: July 8, 2016
Last Updated: July 8, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
United States: Data and Safety Monitoring Board