Clinical trial NCT00241358 (phase 1/phase 2, status: completed)
Conditions: leukemia, myeloid, acute, leukemia, myelogenous, chronic, leukemia, lymphoblastic, acute, lymphocytic leukemia, chronic, myelodysplastic syndromes, multiple myeloma, lymphoma, non-hodgkin, hodgkin disease
ICD codes: C92.A1, C92.A2, C92.61, C92.62, C92.A0, C92.60, C91.01, C91.02, C91.00, C91.11, C91.12, C91.10, D46.9, D46.C, D46.Z, C90.01, C90.02, C90.00, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, C81.77, C81.97, C81.17, C81.27, C81.37, C81.47, C81.70
Drugs: amd3100
SMILES: C(N1CCCNCCNCCCNCC1)C1=CC=C(CN2CCCNCCNCCCNCC2)C=C1
Eligibility criteria:

        Inclusion Criteria:

        Donor criteria:

          -  Donor is 18 to 70 years of age inclusive

          -  If female and of child-bearing age, must be:

               -  non-pregnant,

               -  not breast feeding and

               -  using adequate contraception

          -  Donor is a 6/6 HLA-matched sibling willing to donate peripheral blood stem cell for
             transplant

          -  Donor must be willing to provide written informed consent.

          -  Adequate cardiac function with no history of congestive heart failure and no history
             of atrial fibrillation or ventricular tachyarrhythmia.

          -  Adequate renal function as defined by a serum creatinine clearance of ≥75% of normal
             (Cockcroft-Gault equation)

          -  Adequate hepatic function as defined by a total bilirubin <2x normal or absence of
             hepatic fibrosis/cirrhosis

          -  Adequate neurologic function as defined by:

               -  No evidence of a severe central or peripheral neurologic abnormality.

               -  No history of cerebrovascular accident or seizure disorder requiring
                  anticonvulsant medication

          -  Must be HIV-1 & 2 antibody, HIV-1 antigen, and HTLV-I & II antibody sero-negative, by
             FDA licensed test.

          -  Must have an ECOG performance status of 0 or 1

          -  Must demonstrate ability to be compliant with study regimen.

          -  Must not have an active infection at the time of study entry

          -  Not have active alcohol or substance abuse within 6 months of study entry

          -  Not currently enrolled in another investigational agent study

          -  Not have any medical condition, which, in the opinion of the clinical investigator,
             would interfere with his/her evaluation

        Recipient criteria:

          -  18 to 65 years of age inclusive

          -  Willing and has a 6/6 HLA-matched sibling willing to donate PBSC for transplant

          -  Provide signed informed consent

          -  If female and of child-bearing age, must be:

               -  non-pregnant,

               -  not breast feeding, and

               -  using adequate contraception

        Patient must have one of the following diagnoses:

          -  AML in 1st or subsequent remission or in relapse

          -  ALL in 1st or subsequent remission or in relapse

          -  MDS and intermediate 1 or 2, or high risk by the International Prognostic Scoring
             System

          -  CML in accelerated or second chronic phase

          -  NHL or HD in 2nd or greater complete remission, partial remission,or refractory
             relapse

          -  CLL Rai Stage 2-4, failing at least 2 prior regimens

          -  MM Stage 2-3

          -  Adequate cardiac function with a left ventricular ejection fraction ≥ 40%

          -  Adequate pulmonary function defined as:

               -  No severe or symptomatic restrictive or obstructive lung disease, and

               -  formal pulmonary function testing showing an forced expiratory volume at 1 second
                  (FEV1) ≥50% of predicted and a diffusion capacity of the lung for carbon monoxide
                  (DLCO) ≥40% of predicted, corrected for hemoglobin

          -  Adequate renal function as defined by a serum creatinine clearance of ≥75% of normal
             (Cockcroft-Gault equation)

          -  Adequate hepatic function as defined by a total bilirubin <2x normal or absence of
             hepatic fibrosis/cirrhosis

          -  Adequate neurologic function as defined by no evidence of a severe central or
             peripheral neurologic abnormality. Patients with a history of previous central nervous
             system tumor involvement are eligible provided they are without symptoms or signs and
             the CNS is now free of disease on lumbar puncture and CT scan of the brain

          -  No evidence of active infection at the time of the transplant preparative regimen or
             at the time of transplantation

          -  Patient must be HIV-1 & 2 antibody, HIV-1 antigen, and HTLV-I & II antibody
             sero-negative, by FDA licensed test

          -  ECOG performance status of 0 or 1

          -  Must demonstrate ability to be compliant with medical regimen

          -  Not have active alcohol or substance abuse within 6 months of study entry

          -  Not be concurrently enrolled on another study involving an investigational agent

          -  Not have any medical condition, which, in the opinion of the clinical investigator,
             would interfere with the evaluation of the patient