Tac, Mini-MTX, MMF Versus Tac, MTX for GVHD Prevention | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT01951885

Tac, Mini-MTX, MMF Versus Tac, MTX for GVHD Prevention
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

This randomized clinical trial studies standard GVHD prophylaxis with tacrolimus and methotrexate compared to tacrolimus, mycophenolate mofetil and a reduced-dose methotrexate in patients with hematologic malignancies undergoing allogeneic hematopoietic cell transplant. Both mycophenolate mofetil and reduced-dose methotrexate, in combination with a calcineurin inhibitor, have been shown to be safe and effective in GVHD prevention with less toxicity than standard dose methotrexate. It is not yet known, however, whether this combination of mycophenolate mofetil and reduced-dose methotrexate with tacrolimus is more effective than tacrolimus and standard dose methotrexate in preventing GVHD.

Status: 
Recruiting
Study Date: 
Thu, 05/01/2014 to Mon, 07/02/2018
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Drug: tacrolimus Tacrolimus 0.03 mg/kg/day beginning day -1. Tac will be administered IV over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL Other Names: FK 506 Prograf Drug: methotrexate MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient < 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11. Other Names: amethopterin Folex methylaminopterin Mexate MTX Drug: Mycophenolate mofetil Mycophenolate 1000mg IV twice daily will begin on day +1, and will be converted to oral administration 1000 mg twice a day once patient can tolerate oral route. Patients<40 kg will receive MMF 45 mg/kg/day (15mg/kg IV three times a day). Other Names: Cellcept MMF Drug: Methotrexate (low dose) MTX 5mg/m2 IV on day +1, +3, +6. If patient<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6. Other Names: amethopterin Folex methylaminopterin Mexate MTX