Tac, Mini-MTX, MMF Versus Tac, MTX for GVHD Prevention

PHASE3CompletedINTERVENTIONAL
Enrollment

101

Participants

Timeline

Start Date

July 7, 2014

Primary Completion Date

October 9, 2020

Study Completion Date

August 11, 2021

Conditions
Chronic Myelogenous LeukemiaAcute Lymphoblastic LeukemiaAcute Myeloid LeukemiaAcute Biphenotypic LeukemiaMyelodysplastic SyndromeMyeloproliferative NeoplasmNon-Hodgkin LymphomaHodgkins DiseaseChronic Lymphocytic LeukemiaMultiple Myeloma
Interventions
DRUG

tacrolimus

Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL

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.

DRUG

Mycophenolate mofetil

Patients will receive Mycophenolate beginning on day +1. Patients \>40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients \< 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol

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.

Trial Locations (1)

44195

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland

All Listed Sponsors
lead

Case Comprehensive Cancer Center

OTHER

NCT01951885 - Tac, Mini-MTX, MMF Versus Tac, MTX for GVHD Prevention | Biotech Hunter | Biotech Hunter