Vorinostat for Graft vs Host Disease Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood and Marrow Transplantation

Inclusion Criteria

• •The donor and recipient must have an HLA-match (8/8 HLA-A, -B, -C, and -DRB1) or haploidentical match (per protocol criteria). High resolution typing is required for all alleles.
• •Diagnoses to be included:
• •1. Acute Leukemia in remission. Remission is defined as the absence of blasts in the peripheral circulation at the time of enrollment, \< 5% blasts in the bone marrow and absence of extramedullary disease including CNS involvement.
• •2. Chronic Myeologenous Leukemia (CML) in first or subsequent chronic phase failing to respond (or intolerant) to at least two different tyrosine kinase inhibitors. CML in accelerated or blast phase (CML-AP/BP) are eligible without requirement to fail tyrosine kinase inhibitor therapy, but must be in remission at time of enrollment. Remission is defined as the absence of blasts in the peripheral circulation at the time of enrollment, \<5% blasts in the bone marrow and absence of extramedullary disease including CNS involvement.
• •3. Myelodysplastic syndrome (MDS) with intermediate or high-risk IPSS or equivalent IPSSR score with \< 10% blasts in the bone marrow.
• •4. Mature B Cell Malignancies (including Mantle Cell Lymphoma, Follicular Lymphoma. Diffuse Large B Cell Lymphoma, Non-Hodgkin Lymphoma not otherwise specified).Subjects should have extinguished standard of care options prior to being considered eligible for this trial
• •Subjects aged 3 to 39 years
• •Lansky/Karnofsky Performance Scale score of 70% or higher
• •Life expectancy of greater than 6 months
• •Subjects must have normal organ and marrow function (as defined in protocol)
• •Ability to take oral medication and be willing to adhere to the vorinostat regimen
• •For females of reproductive potential and men: The effects of vorinostat on the developing human fetus are unknown. For this reason and because histone deacetylase inhibitor agents as well as other therapeutic agents used in this trial (e.g., calcineurin inhibitor \[tacrolimus or cyclosporine\], methotrexate, mycophenolate, and cyclophosphamide) are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Women must continue using contraceptives for at least 6 months after the end of therapy and men must continue contraceptive use for 3 months after completion of vorinostat administration.
• •Ability to understand and the willingness to sign a written informed consent document
• •Stated willingness to comply with all study procedures and availability for the duration of the Study