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

Status:	Recruiting
Conditions:	Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Infectious Disease, Lymphoma, Lymphoma, Orthopedic, Women's Studies, Hematology, Hematology, Hematology, Hematology, Hematology, Hematology, Hematology, Hematology, Hematology
Therapuetic Areas:	Hematology, Immunology / Infectious Diseases, Oncology, Orthopedics / Podiatry, Reproductive
Healthy:	No
Age Range:	Any - 70
Updated:	1/5/2019
Start Date:	May 21, 2014
End Date:	July 2019

Tacrolimus, Mini-dose Methotrexate and Mycophenolate Mofetil Versus Tacrolimus and Methotrexate for the Prevention of Acute Graft-versus-Host-Disease

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.

Inclusion Criteria:

- Patients must have one of the following documented diseases:

- Chronic myelogenous leukemia

- Chronic lymphocytic leukemia

- Multiple myeloma

- Myelodysplasia

- Myeloproliferative disorder

- Non-Hodgkin's lymphoma

- Hodgkin's disease

- 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

Exclusion Criteria:

- 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

We found this trial at

sites

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio 44195

Principal Investigator: Betty Hamilton, MD

Phone: 216-444-2529

from

Cleveland, OH