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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

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ClinicalTrials.gov Identifier: NCT00548847
Recruitment Status : Completed
First Posted : October 24, 2007
Results First Posted : August 18, 2016
Last Update Posted : October 26, 2016
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Martha Arellano, Emory University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Interventions Biological: GM-CSF
Biological: Interferon-α-2b
Enrollment 15
Recruitment Details All patients were enrolled at the Winship Cancer Institute of Emory University. The study closed to accrual in May 2011.
Pre-assignment Details  
Arm/Group Title GM-CSF, Interferon-α-2b
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 15
Completed 8
Not Completed 7
Reason Not Completed
Disease progression             7
Arm/Group Title GM-CSF, Interferon-α-2b
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
1
   6.7%
Between 18 and 65 years
13
  86.7%
>=65 years
1
   6.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
9
  60.0%
Male
6
  40.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Hispanic or Latino
1
   6.7%
Not Hispanic or Latino
13
  86.7%
Unknown or Not Reported
1
   6.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   6.7%
White
13
  86.7%
More than one race
0
   0.0%
Unknown or Not Reported
1
   6.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title 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
Hide Description Efficacy is defined as progression-free survival of > 33% at 3 months. This is based on our retrospective data on 10% 3 month survival for relapsed patients. Progression is defined an an increase in blasts in blood or marrow by 50% compared to baseline with at least 20% of all cells being blasts at the time of assessment.
Time Frame 3 months after cytokine treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GM-CSF, Interferon-α-2b
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: percentage of progression-free patients
13
2.Secondary Outcome
Title 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)
Hide Description [Not Specified]
Time Frame 6 months after cytokine treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GM-CSF, Interferon-α-2b
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GM-CSF, Interferon-α-2b
Hide Arm/Group Description 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.
All-Cause Mortality
GM-CSF, Interferon-α-2b
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
GM-CSF, Interferon-α-2b
Affected / at Risk (%)
Total   8/15 (53.33%) 
Blood and lymphatic system disorders   
Hemorrhage *  1/15 (6.67%) 
General disorders   
Death *  5/15 (33.33%) 
Infections and infestations   
Infection *  2/15 (13.33%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea *  1/15 (6.67%) 
Adult Respiratory Distress Syndrome *  1/15 (6.67%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
GM-CSF, Interferon-α-2b
Affected / at Risk (%)
Total   6/15 (40.00%) 
General disorders   
Fever *  1/15 (6.67%) 
Malaise *  1/15 (6.67%) 
Nausea *  1/15 (6.67%) 
Musculoskeletal and connective tissue disorders   
Myalgia *  1/15 (6.67%) 
Arthralgia *  1/15 (6.67%) 
Bone Pain *  1/15 (6.67%) 
*
Indicates events were collected by non-systematic assessment
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: Martha Arellano, MD
Organization: Emory University
Phone: 404-778-1900
EMail: marella@emory.edu
Layout table for additonal information
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 )
First Submitted: October 22, 2007
First Posted: October 24, 2007
Results First Submitted: July 8, 2016
Results First Posted: August 18, 2016
Last Update Posted: October 26, 2016