Clinical trial NCT01220297 (phase 2, status: terminated)
Conditions: hematologic diseases, acute-graft-versus-host disease, leukemia, non-hodgkin lymphoma (nhl), hodgkin lymphoma
ICD codes: E70.338, E70.339, P09.3, O28.0, P61.8, P61.9, T45.8X1A, D89.810, D89.812, 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
Drugs: sirolimus, mycophenolate mofetil (mmf), carmustine, etoposide, cyclophosphamide (cyclo, cy), ftbi
SMILES: CC(=O)CC(C1=CC=CC=C1)C1=C(O)C2=C(OC1=O)C=CC=C2, COC(=O)\C=C\C(O)=O, ClCCNC(=O)N(CCCl)N=O, OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1, ClCCN(CCCl)P1(=O)NCCCO1
Reason stopped: 
    low accrual
  
Eligibility criteria:

        INCLUSION CRITERIA

          -  Acute myelogenous leukemia (AML), beyond 2nd remission or relapsed/refractory disease,
             age 2 to 60 years

          -  AML, in first or subsequent remission or relapsed/refractory disease, age 51 to 60
             years of age

          -  AML with multilineage dysplasia

          -  Acute lymphoblastic leukemia (ALL), beyond 2nd remission or relapsed/refractory
             disease, age 2 to 60 years

          -  ALL, age 51 - 60 years in first or subsequent remission or relapsed/refractory disease

          -  Chronic myeloid leukemia (CML), beyond 2nd chronic phase or in blast crisis

          -  Myelodysplastic syndrome (MDS), including World Health Organization
             (WHO)classifications of refractory anemia with excess blasts-1 (RAEB-1), RAEB-2 and
             therapy-related MDS

          -  MDS with poor long-term survival including myeloid metaplasia and myelofibrosis

          -  Myeloproliferative disorders

          -  High-risk non-Hodgkin lymphoma (NHL) in 1st emission

          -  Relapsed or refractory NHL

          -  Hodgkin lymphoma (HL) beyond first remission

          -  Males and females of any ethnic background, 2 to 60 years of age

          -  Karnofsky Performance Status (KPS) ≥ 70% or Lansky performance status > 70% for
             patients < 16 years of age.

          -  Related, matched-donor identified [6/6 human leukocyte antigen (HLA)-A, B and DRB1]

          -  Willingness to take oral medications during the transplantation period

          -  Ability to understand and the willingness to sign a written informed consent document

        EXCLUSION CRITERIA

          -  Prior myeloablative allogeneic or autologous hematopoietic stem cell transplant (HSCT)

          -  HIV infection

          -  Pregnant

          -  Lactating

          -  Evidence of uncontrolled active infection

          -  Serum creatinine > 1.5 mg/dL or 24-hour creatinine clearance < 50 mL/min

          -  Direct bilirubin, Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >
             2 x upper limit of normal (ULN)

          -  Carbon monoxide diffusing capacity (DlCO) < 60% predicted (adults) OR and in-room air
             oxygen saturation < 92% (children)

          -  Left ventricular ejection fraction < 45% (adults) OR shortening fraction <
             26%(children)

          -  Fasting cholesterol > 300 mg/dL or Triglycerides > 300 mg/dL while on lipid-lowering
             agents.

          -  Receiving investigational drugs unless cleared by the Principal Investigator (PI).

          -  Prior malignancies except basal cell carcinoma or treated carcinoma in-situ.

          -  Cancer treated with curative intent ≤ 5 years (EXCEPTION BY PI DISCRETION) (Cancer
             treated with curative intent > 5 years will be allowed).