Tacrolimus and Mycophenolate Mofetil (MMF) in GVHD Prophylactic Regimen Compared to Tacrolimus and Methotrexate (MTX
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|ClinicalTrials.gov Identifier: NCT00360685|
Recruitment Status : Completed
First Posted : August 7, 2006
Results First Posted : May 3, 2013
Last Update Posted : May 3, 2013
|Condition or disease||Intervention/treatment|
|Mucositis Graft-versus-host Disease||Drug: Tac+MTX Drug: TAC + MMF|
The randomization for this comparative trial will be stratified by conditioning regimen and, for those patients enrolled on MCC-14178, by busulfan AUC level.
All patients will receive daily doses of TAC beginning day -3 (day 0 being the day of hematopoietic stem cell transplant (HCT)) and will be given until day +60 when tapering will begin in the absence of GVHD. Provided no GVHD develops, TAC should be discontinued by day +180. Doses will be adjusted to maintain blood levels.
In addition to TAC, patients will be randomized to one of the following additional anti-GVHD medications: MTX or MMF beginning day 0 at least 2 hours after the end of the HCT. In the absence of GVHD a tapering schedule will begin on day +240 and be completed on day +360.
Study participants will be extensively monitored as inpatients and then weekly as outpatients. Some tests will be conducted at least twice weekly (blood tests, toxicity data, GVHD and physical exams) one-month post-transplant and during the tapering off periods for up to 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety of Tacrolimus And Methotrexate (MTX) Versus Tacrolimus And Mycophenolate Mofetil (MMF) As Graft Versus Host Disease Prophylaxis In Allogeneic Hematopoietic Cell Transplants (HCT)|
|Study Start Date :||September 2005|
|Primary Completion Date :||January 2011|
|Study Completion Date :||January 2011|
TAC + MMF
Tacrolimus and Mycophenolate
Drug: TAC + MMF
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
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.
- Incidence of Severe Mucositis [ Time Frame: 2 year ]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.
- Incidence of Acute Graft-vs-host Disease (aGVHD) [ Time Frame: 100 days post transplant ]incidence of aGVHD (grades 2 - 4) 100 days post allogeneic hematopoietic cell transplantation
- Overall Survival [ Time Frame: 1 year ]number of participants alive at one year
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00360685
|United States, Florida|
|H. Lee Moffitt Cancer Center & Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Janelle Perkins, PharmD||H. Lee Moffitt Cancer Center and Research Institute|
|Principal Investigator:||Teresa Field, PhD, MD||H. Lee Moffitt Cancer Center and Research Institute|