Treatment of Single or Double Umbilical Cord Trans + Graft-versus-host Disease (GVHD) Prophylaxis w/ Tacrolimus & Mycophenolate Mofetil

Inclusion Criteria

• •Patient and UCB Unit Selection:
• •Only one of the following should be present:
• •Acute leukemia (lymphocytic or myeloid or undifferentiated or biphenotypic) in complete remission 2 or beyond
• •Acute lymphocytic leukemia, Philadelphia chromosome positive in complete remission 1 or beyond
• •Acute myeloid leukemia in complete remission 1 if it has evolved from a myeloproliferative disorder (MPD) or myelodysplastic syndrome (MDS).
• •Acute leukemia in complete remission 1 if there is a failure to recover normal blood counts or the development of MDS following induction chemotherapy.
• •Therapy related acute leukemia in complete remission 1 or beyond
• •Chronic myeloid leukemia (CML) chronic phase-1 (imatinib failures, imatinib intolerance), or any CML beyond first chronic phase
• •Myelodysplastic syndromes (Intermediate -1 or higher risk by IPSS)
• •Therapy related MDS (irrespective of IPSS)
• •Multiple myeloma must have had prior chemotherapy or autologous transplant
• •Chronic lymphocytic leukemia must have failed two lines of conventional therapy but still chemosensitive to third line therapy.
• •Chemosensitive Non-Hodgkin's lymphoma or Hodgkin's lymphoma in CR or PR after failing induction therapy.
• •High risk acute leukemia/lymphoma eg Nk/T cell, HTLV associated leukemia/lymphoma, other T cell lymphoma/leukemia in first best response
• •For patients with acute leukemia-they must be in a remission (less than 5% leukemic marrow blasts) at time of study entry.
• •Karnofsky score of \> 70%
• •Estimated creatinine clearance of \> 60 ml/min
• •Left ventricular ejection fraction of \>50%
• •Pulmonary function test with DLCO, FEV1 and FVC of \>60%
• •Total bilirubin and SGOT of \< 3.0 x upper limits of normal
• •Note: Age 18- 40 years for adult myeloablative conditioning Age \> 40 -50 years for adult reduced intensity conditioning
• •Karnofsky or Lansky score of \> 70%
• •Estimated Creatinine clearance of \> 60 ml/min
• •Left ventricular ejection fraction of \>50%
• •Pulmonary function test with FEV1 and FVC of \>60% (for patients \>6 years of age)
• •Total bilirubin and SGOT of \< 3.0 x upper limits of normal
• •Note: All pediatric patients will receive myeloablative conditioning
• •No available HLA identical or 1 antigen/allele mismatched (Class I-A, B or Class II DR locus) related donor
• •At least a HLA 4/6 match (Class I-A, B by low resolution, Class II-DR by high resolution) to recipient
• •For double UCB SCT each unit should be at least a 4/6 match (Class I-A,B by low resolution, Class II-DR by high resolution) to recipient, and should be at least a 4/6 match (Class I-A,B by low resolution, Class II-DR by high resolution) to each other
• •For Single UCB SCT: the unit will have ≥ 3.5 X 107 NC/kg of recipient body weight (For pediatric patients a cell dose ≥ 3.0 X 107 NC/kg of recipient body weight is acceptable). Recipient body weight will be determined as per standard guidelines.
• •For Double UCB SCT: (done only if no single UCB unit ≥ 3.5 X 107 NC/kg of recipient body weight is available for adults, and ≥ 3.0 X 107 NC/kg of recipient body weight is available for pediatric patients )
• •The larger of the two units (UCB1) will have a minimum cell dose of 2.0 X 107 NC/kg of recipient body weight. The smaller of the two units (UCB2) will have a minimum of 0.5 X 107 NC/kg of recipient body weight.
• •The total cell dose UCB1 + UCB2 will be ≥ 2.5 X 107 NC/kg of recipient body weight.
• •Adult patients eligible for a double UCB SCT but without an appropriate second UCB unit will be enrolled in the study if their single UCB unit contains ≥ 2.5 x 107 NC/kg recipient body weight.