NCT00506948|TerminatedPhase 2Results
Study Stopped
Halted due to high incidence of veno-oclusive disease of the liver.
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Halted due to high incidence of veno-oclusive disease of the liver.
Sponsor study identifier
interventional
13
1 country
1
Study Start
September 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2010
Actual (reported)Study Completion
October 2010
Actual (reported)The goal of this clinical research study is to learn if the combination of rabbit anti-thymocyte globulin (Thymoglobulin®), sirolimus (Rapamune®), and mycophenolate mofetil (Cellcept®) can help to prevent graft versus host disease (GVHD). The safety of this drug combination will also be studied. Primary Objective: To determine efficacy and toxicity of a regimen of thymoglobulin, sirolimus and mycophenolate mofetil for prevention of acute GVHD after allogeneic stem cell transplantation from human leukocyte antigen (HLA) identical related or unrelated donors. Secondary Objective: To assess engraftment, chronic GVHD, relapse and survival.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2006
Date type not reportedThis date has not been verified as actual or estimated.
July 20, 2007
Actual (reported)July 25, 2007
Actual (reported)October 2010
Actual (reported)October 2010
Actual (reported)February 20, 2014
Actual (reported)Failure Rate
Efficacy failure defined as a participants who had either grade 3-4 acute graft-versus-host disease (aGVHD) or treatment related mortality (TRM) within 100 days post transplant. Failure Rate calculated as (# of failures) / (# participants evaluated). Physical exam and bloodwork every week (for the first 90-100 days after the transplant).
Baseline to 100 days post transplant
Number of Participants With Acute Graft-versus-host Disease (aGVHD)
Participants who had acute graft-versus-host disease (aGVHD) within 100 days post transplant. Physical exam and bloodwork every week (for the first 90-100 days after the transplant).
Baseline to 100 days post transplant
Thymoglobulin 1.5 mg/kg intravenous (IV) days -4, -3, -2, -1 before Stem Cell Transplant (Day 0); Sirolimus 6 mg IV on day -2 followed by 2 mg daily to maintain therapeutic levels and Mycophenolate Mofetil (MMF) 15 mg/kg IV or orally every 12 hours starting on day 0 until day+27.
15 mg/kg by vein or by mouth every 12 hours.
1.5 mg/kg by vein daily for 4 days
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
A decision to terminate this trial was made due to the high incidence of veno-occlusive disease of the liver in participants receiving this graft-versus-host disease (GVHD) prophylaxis regimen.
Amin Alousi, MD
M.D. Anderson Cancer Center
13 participants (actual enrollment reported by the registry).
First Submitted
July 20, 2007
First Posted
July 25, 2007
Study Start
September 2006
Date type not reportedThis date has not been verified as actual or estimated.
6 mg daily by mouth for 1 day, followed by 2 mg daily for 1 day.
Stem cell infusion on Day 0.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
October 2010
Actual (reported)Study Completion
October 2010
Actual (reported)Last Updated
September 24, 2020
Results First Posted
February 20, 2014
Record last verified: 2020-09
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Source: ClinicalTrials.gov.
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