This is a phase II trial using a non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen with modifications based on factors including diagnosis, disease status, and prior treatment. Single or double unit selected according to current University of Minnesota umbilical cord blood graft selection algorithm.
Name: Fludarabine
Name: Cyclophosphamide
Name: MMF
Name: Sirolimus
Name: TBI
Name: Umbilical cord blood cell infusion
Name: ATG
Description: Simple proportions will be used to estimate the probability of grade II-IV actue GVHD.
Measure: Probability of Acute Graft Versus Host Disease (GVHD) Time: Day 100Description: Percentage of patients with grade III-IV acute GVHD.
Measure: Incidence of Acute GVHD Time: Day 100Description: Percentage of subjects with donor chimerism.
Measure: Chimerism Time: Day 21Description: Percentage of subjects with donor chimerism.
Measure: Chimerism Time: Day 100Description: Percentage of subjects with donor chimerism.
Measure: Chimerism Time: Day 180Description: Percentage of subjects with donor chimerism.
Measure: Chimerism Time: 1 year post transplantDescription: Percentage of subjects with neutrophil engraftment.
Measure: Neutrophil Engraftment Time: Day 42Allocation: Non-Randomized
Parallel Assignment
There is one SNP
t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1 - 30 years of age or older at diagnosis - White blood cell counts of greater than 30,000/mcL (B-ALL) or greater than 100,000/mcL (T-ALL) at diagnosis - CNS leukemia involvement during the course of disease - Slow cytologic response (>10% lymphoblasts in bone marrow on Day 14 of induction therapy) - Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy - Biphenotypic/Undifferentiated/Prolymphocytic Leukemias in first or subsequent CR - Chronic myelogenous leukemia in chronic or accelerated phase, or CML blast crisis in morphological remission (<5% blasts): Chronic phase patients must have failed at least two tyrosine kinase inhibitors, been intolerant to all available TKIs, or have T315I mutation. --- T315I ---