Clinical trial NCT01350258 (phase 1/phase 2, status: terminated)
Conditions: hematologic malignancies, acute leukemia, myelodysplastic syndromes (mds) other than ra or rars subtypes, hodgkin's lymphoma, non-hodgkin's lymphoma, myeloma, chronic myelogenous (or myeloid) leukemia (cml) resistant to sti therapy
ICD codes: E70.338, E70.339, P09.3, O28.0, P61.8, P61.9, T45.8X1A, C91.01, C91.02, C92.01, C92.02, C92.41, C92.42, C92.51, 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, C90.01, C90.02, C90.00, Z19.2, A41.02, A49.02, J15.212, Z86.14, Z22.322, B95.62
Drugs: fludarabine, thiotepa, melphalan
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, CN(C)CCOC(C)(C1=CC=CC=C1)C1=CC=CC=N1, N[C@@H](CC1=CC=C(C=C1)N(CCCl)CCCl)C(O)=O
Reason stopped: 
    poor accrual
  
Eligibility criteria:

        Inclusion Criteria:

          1. Any patient with a high-risk hematologic or oncologic diagnosis in which allogeneic
             HSCT is thought to be beneficial, and in whom front-line therapy has already been
             applied. High risk is defined as:

               -  Acute leukemia in 3rd or greater CR or with persistent disease

               -  Myelodysplastic syndrome (MDS) other than RA or RARS subtypes.

               -  Hodgkin's or Non-Hodgkin's lymphoma in 3rd or greater remission or with
                  persistent disease.

               -  Myeloma in 3rd or greater remission or with less than PR to most recent therapy.

               -  Chronic myelogenous (or myeloid) leukemia (CML) resistant to STI therapy

          2. Patients must have a related donor who is at least a 4 antigen match at the HLA-A; B;
             C; DR loci.

          3. Patients must adequate organ function:

               -  LVEF of > or = 50%

               -  DLCO > or = 50% of predicted corrected for hemoglobin

               -  Adequate liver function as defined by a serum bilirubin < or = 1.8, AST or ALT <
                  or = 2.5X upper limit of normal

               -  GFR of > or = 60 mL/min/1.73m2

          4. Performance status > or = 80% (TJU Karnofsky) for patients > or = 60 years old or > or
             = 70% for patients < 60.

          5. HCT-CI Score < or = 4 points for patients > or = 60 years old or < or = 5 points for
             patients < 60.

          6. Patients must be willing to use contraception if they have childbearing potential

          7. Able to give informed consent

        Exclusion Criteria:

          1. Performance status < 80% (TJU Karnofsky) for patients > or = 60 years old or < 70% for
             patients < 60.

          2. HCT-CI Score > 4 points for patients > or = 60 years old or > 5 points for patients <
             60.

          3. HIV positive

          4. Active involvement of the central nervous system with malignancy

          5. Inability to obtain informed consent

          6. Pregnancy

          7. Patients with life expectancy of < 6 months for reasons other than their underlying
             hematologic/oncologic disorder

          8. Patients who have received alemtuzumab within 8 weeks of the transplant admission, or
             who have recently received horse or rabbit ant-thymocyte globulin and have an ATG
             level of > or = 2 ugm/ml

          9. Patients with evidence of another malignancy, exclusive of a skin cancer that requires
             only local treatment, should not be enrolled on this protocol

        Donor Selection All donors are selected and screened for their ability to provide adequate
        infection-free apheresis products for the patient in a manner that does not put the donor
        at risk for negative consequences. Donor selection will be in compliance with 21 CFR 1271
        and TJU BMT Program SOP CP: P009.03.