Feasibility Study of the Assessment of Symptom-Related Cytokines in AML/MDS Patients Undergoing Allogeneic Blood or Marrow Transplantation
Sponsor study identifier
observational
30
1 country
1
Study Start
May 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2008
Actual (reported)Study Completion
September 2008
Actual (reported)Primary Objective: 1\. To assess the self-reported symptoms and the plasma cytokine levels of AML/MDS patients pretransplantation and posttransplantation with allogeneic blood and marrow in order to identify changes in symptoms (or symptom clusters) and changes in cytokines that may be related to the conditioning regimen and/or to the development of GVHD during the 100 days posttransplant. Based on the current literature, both animal and human research, in this study we hypothesize that increases in TNF alpha to be associated with poor appetite, sleep disturbance and fatigue, but not with increases in pain, depression and numbness.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2008
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2004
Date type not reportedThis date has not been verified as actual or estimated.
July 18, 2007
Actual (reported)July 20, 2007
Actual (reported)September 2008
Actual (reported)September 2008
Actual (reported)Drawing blood samples and matching the test results with questionnaire responses for symptoms patients experience from transplant treatment.
Questionnaires (30 minutes each) + instruction on telephone survey system for measuring symptoms. Questionnaires 2 times a week while in the hospital or until able to use the telephone survey system.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients, over 18 years, scheduled for allogeneic translantation (bone marrow or peripheral blook stem cell) at UT MD Anderson Cancer Center.
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
At admission, blood sample drawn (around 2½ tablespoons) to measure levels of cytokines before transplant procedure, then another three days postadmission, on day of transplant, 1 day after transplant, 3 days, 8 days, 15 days, 22 days, 29 days postransplant, then between 50 - 60 days postransplant and again 80 - 100 days after transplant.
Xin Shelley Wang, MD
M.D. Anderson Cancer Center
30 participants (actual enrollment reported by the registry).
First Submitted
July 18, 2007
First Posted
July 20, 2007
Study Start
May 2004
Date type not reportedThis date has not been verified as actual or estimated.
Phase I/II Study of 5-Azacytidine With Ara-C in Patients With Relapsed/Refractory Acute Myelogenous Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)
Contact the study team to confirm eligibility.
Primary Completion
September 2008
Actual (reported)Study Completion
September 2008
Actual (reported)Last Updated
August 1, 2012
Record last verified: 2012-07
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Source: ClinicalTrials.gov.
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