Clinical trial NCT00489203 (phase 2, status: completed)
Conditions: hematopoietic/lymphoid cancer, accelerated phase chronic myelogenous leukemia, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (mll) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), atypical chronic myeloid leukemia, blastic phase chronic myelogenous leukemia, childhood acute lymphoblastic leukemia in remission, childhood acute myeloid leukemia in remission, childhood chronic myelogenous leukemia, childhood myelodysplastic syndromes, chronic eosinophilic leukemia, chronic myelomonocytic leukemia, chronic neutrophilic leukemia, chronic phase chronic myelogenous leukemia, contiguous stage ii adult burkitt lymphoma, contiguous stage ii adult diffuse large cell lymphoma, contiguous stage ii adult diffuse mixed cell lymphoma, contiguous stage ii adult diffuse small cleaved cell lymphoma, contiguous stage ii adult immunoblastic large cell lymphoma, contiguous stage ii adult lymphoblastic lymphoma, contiguous stage ii grade 1 follicular lymphoma, contiguous stage ii grade 2 follicular lymphoma, contiguous stage ii grade 3 follicular lymphoma, contiguous stage ii mantle cell lymphoma, contiguous stage ii marginal zone lymphoma, contiguous stage ii small lymphocytic lymphoma, de novo myelodysplastic syndromes, essential thrombocythemia, extramedullary plasmacytoma, extranodal marginal zone b-cell lymphoma of mucosa-associated lymphoid tissue, graft versus host disease, isolated plasmacytoma of bone, juvenile myelomonocytic leukemia, meningeal chronic myelogenous leukemia, myelodysplastic/myeloproliferative disease, unclassifiable, nodal marginal zone b-cell lymphoma, noncontiguous stage ii adult burkitt lymphoma, noncontiguous stage ii adult diffuse large cell lymphoma, noncontiguous stage ii adult diffuse small cleaved cell lymphoma, noncontiguous stage ii adult immunoblastic large cell lymphoma, noncontiguous stage ii adult lymphoblastic lymphoma, noncontiguous stage ii grade 1 follicular lymphoma, noncontiguous stage ii grade 2 follicular lymphoma, noncontiguous stage ii grade 3 follicular lymphoma, noncontiguous stage ii mantle cell lymphoma, noncontiguous stage ii marginal zone lymphoma, noncontiguous stage ii small lymphocytic lymphoma, previously treated myelodysplastic syndromes, primary myelofibrosis, recurrent adult acute lymphoblastic leukemia, recurrent adult acute myeloid leukemia, recurrent adult burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult grade iii lymphomatoid granulomatosis, recurrent adult hodgkin lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult t-cell leukemia/lymphoma, recurrent cutaneous t-cell non-hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent mycosis fungoides/sezary syndrome, recurrent small lymphocytic lymphoma, recurrent/refractory childhood hodgkin lymphoma, refractory chronic lymphocytic leukemia, refractory hairy cell leukemia, relapsing chronic myelogenous leukemia, secondary myelodysplastic syndromes, stage i adult burkitt lymphoma, stage i adult diffuse large cell lymphoma, stage i adult diffuse mixed cell lymphoma, stage i adult diffuse small cleaved cell lymphoma, stage i adult hodgkin lymphoma, stage i adult immunoblastic large cell lymphoma, stage i adult lymphoblastic lymphoma, stage i adult t-cell leukemia/lymphoma, stage i childhood hodgkin lymphoma, stage i chronic lymphocytic leukemia, stage i cutaneous t-cell non-hodgkin lymphoma, stage i grade 1 follicular lymphoma, stage i grade 2 follicular lymphoma, stage i grade 3 follicular lymphoma, stage i mantle cell lymphoma, stage i marginal zone lymphoma, stage i multiple myeloma, stage i mycosis fungoides/sezary syndrome, stage i small lymphocytic lymphoma, stage ii adult hodgkin lymphoma, stage ii adult t-cell leukemia/lymphoma, stage ii chronic lymphocytic leukemia, stage ii cutaneous t-cell non-hodgkin lymphoma, stage ii multiple myeloma, stage ii mycosis fungoides/sezary syndrome, stage iii adult burkitt lymphoma, stage iii adult diffuse large cell lymphoma, stage iii adult diffuse mixed cell lymphoma, stage iii adult diffuse small cleaved cell lymphoma, stage iii adult hodgkin lymphoma, stage iii adult immunoblastic large cell lymphoma, stage iii adult lymphoblastic lymphoma, stage iii adult t-cell leukemia/lymphoma, stage iii chronic lymphocytic leukemia, stage iii cutaneous t-cell non-hodgkin lymphoma, stage iii grade 1 follicular lymphoma, stage iii grade 2 follicular lymphoma, stage iii grade 3 follicular lymphoma, stage iii mantle cell lymphoma, stage iii marginal zone lymphoma, stage iii multiple myeloma, stage iii mycosis fungoides/sezary syndrome, stage iii small lymphocytic lymphoma, stage iv adult burkitt lymphoma, stage iv adult diffuse large cell lymphoma, stage iv adult diffuse mixed cell lymphoma, stage iv adult diffuse small cleaved cell lymphoma, stage iv adult hodgkin lymphoma, stage iv adult immunoblastic large cell lymphoma, stage iv adult lymphoblastic lymphoma, stage iv adult t-cell leukemia/lymphoma, stage iv chronic lymphocytic leukemia, stage iv cutaneous t-cell non-hodgkin lymphoma, stage iv grade 1 follicular lymphoma, stage iv grade 2 follicular lymphoma, stage iv grade 3 follicular lymphoma, stage iv marginal zone lymphoma, stage iv mycosis fungoides/sezary syndrome, stage iv small lymphocytic lymphoma
ICD codes: C96.9, D47.9, C96.Z, D47.Z9, Z80.7, Z85.79, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C83.57, C83.50, C91.01, C91.02, C83.52, C83.56, C83.53, C90.01, C90.21, C90.31, C92.31, C95.91, F10.11, F10.21, R19.5, H35.09, M26.50, M26.59, Q99.8, R06.89, R06.9, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C83.57, C83.50, C91.01, C91.02, C83.52, C83.56, C83.53, F80.81, F84.3, F93.8, F93.9, R62.0, E71.520, F64.2, J82.83, K20.0, K52.82, I42.3, J82.81, J82.82, L98.3, C93.11, C93.12, C93.10, L98.2, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, D46.Z, D46.9, C94.6, D46.C, D47.3, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, D89.810, D89.811, D89.813, D89.812, C93.31, C93.32, C93.30, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, D46.Z, D46.9, C94.6, D46.C, D75.81, C94.41, C94.42, C94.40, C83.57, C83.50, C91.01, C91.02, C83.52, C83.56, C83.53, G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, A87.2, K52.832, D72.111, C91.11, C91.12, C91.10, D46.4, D46.1, D46.A, D46.0, D46.20, D46.21, D46.22, M94.1, A68.9, A68.0, A68.1, M35.6, D46.Z, D46.9, C94.6, D46.C, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, C91.11, C91.12, C91.10, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, C90.01, C90.02, C90.00, D68.61, D69.41, D81.4, E24.1, E26.01, E26.81, E34.0, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, C91.11, C91.12, C91.10, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, C90.01, C90.02, C90.00, D68.61, D69.41, D81.4, E24.1, E26.01, E26.81, E34.0, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, C91.11, C91.12, C91.10, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, C90.01, C90.02, C90.00, D68.61, D69.41, D81.4, E24.1, E26.01, E26.81, E34.0, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, C91.11, C91.12, C91.10, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, D68.61, D69.41, D81.4, E24.1, E26.01, E26.81, E34.0, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: beclomethasone dipropionate, placebo, tacrolimus, methotrexate
SMILES: [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)COC(=O)CC)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, COC1=CC2=C(C(OC)=C1OC)C1=CC=C(OC)C(=O)C=C1C(CC2)NC(C)=O, CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O
Eligibility criteria:

        Inclusion

          -  Allogeneic HCT with marrow or growth-factor mobilized blood cells from an HLA-A, B, C,
             DRB1, and HLA-DQB1-allele matched or single-allele or antigen mismatched related or
             unrelated donor

          -  Use of myeloablative pre-transplant conditioning regimen with > 800 cGy total body
             irradiation and cyclophosphamide, or high-dose busulfan and cyclophosphamide

          -  Use of methotrexate and tacrolimus for prevention of GVHD after allogeneic HCT

          -  Informed consent document signed

        Exclusion

          -  Cord blood transplant recipients

          -  Use of T cell depletion or rabbit antithymocyte globulin to prevent acute GVHD

          -  Treatment with rabbit antithymocyte globulin or alemtuzumab within 3 months before the
             date of HCT

          -  Participation in another therapeutic trial where the primary endpoint is related to
             acute GVHD

          -  Hospitalization at the beginning of the pre-transplant conditioning regimen because of
             pre-existing medical complications

          -  Glucocorticoid treatment at prednisone-equivalent doses > 0.2 mg/kg/day

          -  Known intolerance to BDP

          -  Anticipated inability to tolerate oral administration of study drug tablets for any
             reason during the first two weeks after HCT

          -  Body weight < 35 kg (lower-dose formulations are not available for subjects with lower
             body weight)

          -  Pregnancy or breast feeding

          -  Women of child-bearing potential who are unwilling to use a reliable method of
             contraception

          -  Incarceration