Non Hodgkin Lymphoma Clinical Trial
Tac, Mini-MTX, MMF Versus Tac, MTX for GVHD Prevention
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.
Study Design This is a prospective randomized trial to determine the effectiveness of different doses of GVHD prophylaxis on mucositis, engraftment and aGVHD. Study consists of two study groups of 50 subjects each.
Group A will receive Tac and MTX (15 mg/m2 day +1, 10 mg/m2 day +3, +6, +11). Group B will receive Tac, Mini-dose MTX (5 mg/m2 on day +1, +3, +6) and MMF.
Patients must have one of the following documented diseases:
Chronic myelogenous leukemia
Chronic lymphocytic leukemia
Acute myelogenous leukemia
Acute lymphoblastic leukemia
Acute biphenotypic leukemia
Patients must be undergoing a myeloablative allogeneic hematopoietic cell transplant with one of the following conditioning regimens:
Busulfan (≥ 12.8 mg/kg IV or PO) and cyclophosphamide (≥ 120 mg/kg)
--- Busulfan dose may be adjusted according to pharmacokinetics targeting a daily AUC of 5000 μmol-min/L, per institution standard of practice.
Total body irradiation (TBI) (≥ 1200 cGy) and etoposide (60 mg/kg)
TBI (≥ 1200 cGy) and cyclophosphamide (120 mg/kg)
Patient must have achieved and be in complete morphologic remission prior to starting conditioning regimen
Patient's donor must be a related or unrelated human leukocyte antigen (HLA) 8/8 allele-level match (HLA-A, B, C and DRB1)
Adult patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; pediatric patients must have Lansky score ≥ 60%
Patients must have a life expectancy of 100 days
Patients must sign written informed consent
Patients who have undergone any prior transplant
Patients who are seropositive for human immunodeficiency virus (HIV)
Patients with any medical illness or concurrent psychiatric illness which, in the investigators' opinion, cannot be adequately controlled with appropriate therapy
Patients who are pregnant or lactating
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There is 1 Location for this study
Cleveland Ohio, 44195, United States
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