Clinical trial NCT00143559 (phase 2, status: completed)
Conditions: leukemia, acute lymphoblastic leukemia, acute myeloid leukemia, chronic myeloid leukemia, juvenile myelomonocytic leukemia, myelodysplastic syndrome, paroxysmal nocturnal hemoglobinuria, hodgkin's lymphoma, non-hodgkin lymphoma
ICD codes: C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C91.01, C91.02, C91.00, C92.A1, C92.A2, C92.61, C92.62, C92.A0, C92.60, C92.11, C92.12, C92.21, C92.22, C92.10, C92.20, C93.31, C93.32, C93.30, D46.9, D46.C, D46.Z, D59.5, 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: systematic chemotherapy and antibodies
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC
Eligibility criteria:

        Inclusion Criteria:

        Eligible participants were assigned to one of two different strata dependent on diagnosis,
        disease status and/or past transplant experience. Both strata received the same
        intervention but will be followed and analyzed separately.

          -  Group A must have one of the following diagnosis

               -  Acute lymphoid leukemia (ALL) in second or subsequent remission or high risk in
                  first remission

               -  Acute myeloid leukemia (AML) in remission or with ≤ 25% blasts in bone marrow

               -  Chronic myeloid leukemia (CML)

               -  Juvenile myelomonocytic leukemia (JMML)

               -  Myelodysplastic syndrome (MDS)

               -  Paroxysmal nocturnal hemoglobinuria (PNH)

               -  Hodgkin's (HD) or non-Hodgkin's lymphoma (NHL) in second or subsequent remission
                  after autologous HSCT, or unable to have hematopoietic stem cells collected for
                  autologous HSCT

          -  Group B must have one of the following refractory diagnosis (chemoresistant relapse or
             primary induction failure)

               -  Acute lymphoid leukemia (ALL)

               -  Acute myeloid leukemia (AML) ≥ 25% blast in bone marrow

               -  Secondary AML / MDS

               -  Chronic myeloid leukemia (CML) in accelerated phase or blast crisis

               -  Juvenile myelomonocytic leukemia (JMML)

               -  Myelodysplastic syndrome (MDS)

               -  Hodgkin's (HD) or non-Hodgkin's lymphoma (NHL) with residual disease followed by
                  autologous HSCT or who have chemo-resistant disease

               -  Or patients who have undergone prior allogeneic HSCT or who have a co-morbid
                  condition that in the medical opinion of the Transplant Faculty makes standard
                  myeloablation prohibited

          -  At least 2 and less than or equal to 21 years of age

          -  Lacks suitable HLA-identical sibling or matched available unrelated donor and has a
             mismatched family member donor that is available, HIV negative and at least 18 years
             old

          -  Cardiac shortening fraction ≥ 25%

          -  Creatinine clearance ≥ 40 cc/min/1.73m^2

          -  FVC ≥ 40% of predicted or pulse oximetry ≥ 92% on room air

          -  Direct bilirubin ≤ 3 mg/dL or SGPT ≤ 500 U/L

          -  Karnofsky or Lansky (age dependent) performance score of ≥ 50

        Exclusion Criteria:

          -  Known allergy to murine products

          -  Lactating (female patient)

          -  Pregnancy (female patient)

          -  Active central nervous system (CNS) leukemia