Safety of Tacrolimus And Methotrexate (MTX) Versus Tacrolimus And Mycophenolate Mofetil (MMF) As Graft Versus Host Disease Prophylaxis In Allogeneic Hematopoietic Cell Transplants (HCT)
Sponsor study identifier
interventional
89
1 country
1
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2011
Actual (reported)Study Completion
January 2011
Actual (reported)A comparative trial where all patients will receive daily doses of tacrolimus (TAC) until day +60 when tapering will begin, in the absence of graft-versus-host disease (GVHD), and discontinued by day +180. In addition patients will be randomized to methotrexate (MTX) or mycophenolate mofetil (MMF) and again, in the absence of GVHD, a tapering schedule will begin on day +240 and be completed on day +360. Doses will be adjusted to maintain blood levels.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2011
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 2005
Date type not reportedThis date has not been verified as actual or estimated.
August 3, 2006
Actual (reported)August 7, 2006
Actual (reported)January 2011
Actual (reported)January 2011
Actual (reported)May 3, 2013
Actual (reported)Incidence of Severe Mucositis
Mucositis was assessed prospectively daily while the patient was hospitalized and graded retrospectively based on nurse and clinician assessments according to the clinical criteria set forth in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 3.0). Severe mucositis as defined as grade 3 or grade 4.
2 year
Incidence of Acute Graft-vs-host Disease (aGVHD)
100 days post transplant
Overall Survival
1 year
Tacrolimus and Mycophenolate
Tacrolimus and Methotrexate
Tacrolimus- 0.03mg/kg/24h IV beginning day-3 Methotrexate- 15mg/m2 IV day +1 then 10mg/m2 IV on days 3, 6, 11 post transplant.
Tacrolimus- 0.03 mg/kg/24h as a continuous IV infusion, beginning day -3. Mycophenolate Mofetil- 30 mg/kg/day IV in 2 divided doses (q12 hours) beginning day 0 at least 2 hours after the end of the hematopoietic stem cell transplant
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Perkins J, Field T, Kim J, Kharfan-Dabaja MA, Fernandez H, Ayala E, Perez L, Xu M, Alsina M, Ochoa L, Sullivan D, Janssen W, Anasetti C. A randomized phase II trial comparing tacrolimus and mycophenolate mofetil to tacrolimus and methotrexate for acute graft-versus-host disease prophylaxis. Biol Blood Marrow Transplant. 2010 Jul;16(7):937-47. doi: 10.1016/j.bbmt.2010.01.010. Epub 2010 Jan 25.
Janelle Perkins, PharmD
H. Lee Moffitt Cancer Center and Research Institute
Teresa Field, PhD, MD
H. Lee Moffitt Cancer Center and Research Institute
89 participants (actual enrollment reported by the registry).
First Submitted
August 3, 2006
First Posted
August 7, 2006
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
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
January 2011
Actual (reported)Study Completion
January 2011
Actual (reported)Last Updated
May 3, 2013
Results First Posted
May 3, 2013
Record last verified: 2013-03
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Source: ClinicalTrials.gov.
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