This phase III randomized clinical trial studies tacrolimus and methotrexate with or without mycophenolate mofetil in preventing graft-vs-host disease (GVHD) in patients with hematological malignancy undergoing donor stem cell transplant. Tacrolimus, methotrexate, and mycophenolate mofetil may be an effective treatment for graft-versus-host disease caused by stem cell transplant. It is not yet known whether tacrolimus and methotrexate is more effective with or without mycophenolate mofetil in preventing GVHD.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01951885.
PRIMARY OBJECTIVES:
I. To determine the incidence, length and severity of mucositis from day 0 until day of discharge or day +28 (whichever comes first) after allogeneic bone marrow transplantation comparing tacrolimus (Tac), mini-dose methotrexate (MTX) and mycophenolate mofetil (MMF) with Tac and MTX.
II. To study rates of neutrophil and platelet engraftment comparing Tac, mini-dose MTX and MMF versus Tac and MTX.
III. To study the incidence of acute graft-versus-host disease in human leukocyte antigen (HLA) matched related and unrelated allogeneic bone marrow transplantation using a myeloablative preparative regimen comparing Tac, mini-dose MTX and MMF with Tac and MTX.
SECONDARY OBJECTIVES:
I. Length of hospitalization/time to discharge.
II. Use of TPN (total parenteral nutrition).
III. Length of time on continuous infusion narcotics.
IV. Incidence of infection in the first 100 days post-transplantation.
V. Incidence of hepatotoxicity in first 100 days post-transplantation.
VI. Incidence of nephrotoxicity in first 100 days post-transplantation.
VII. Incidence of pulmonary toxicity in first 180 days post-transplantation.
VIII. Incidence and severity of grade II-IV and III-IV acute GVHD.
IX. Incidence and severity of chronic GVHD.
X. One year relapse-free and overall survival.
OUTLINE: Patients are randomized to 1 of 2 treatment groups.
GROUP A: Patients receive tacrolimus intravenously (IV) over 24 hours continuously beginning on day -1 and then orally (PO) twice daily (BID) after engraftment with a taper from day 100 to day 180 (in the absence of GVHD). Patients also receive methotrexate IV on days 1, 3, 6, and 11.
GROUP B: Patients receive tacrolimus as in group A and methotrexate IV on days 1, 3, and 6. Patients also receive mycophenolate mofetil PO BID or IV BID beginning on day 1, with a taper from day 45 to day 100 (in the absence of GVHD).
After completion of study treatment, patients are followed up for 1 year.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorBetty Ky Hamilton
