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Report for Clinical Trial NCT02722668
 Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene 
      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
Description: Both Arms: 30 mg/m^2 IV over 1 hour Day -6 to Day -2
 Type: Drug
Group Labels:  2  ATG  No ATG  
 Name: Cyclophosphamide
Description: Arm 1: 50 mg/kg IV over 2 hours Day -6
 Type: Drug
Group Labels:  2  ATG  No ATG  
 Name: MMF
Description: Both Arms:
Mycophenolate mofetil (MMF) 3 gram/day IV/PO for patients who are ≥ 40 kg divided in 2 or 3 doses. In obese patients (>125% IBW) 15 mg/kg every 12 hours may be considered. Pediatric patient (<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours beginning Day -3. MMF dosing will be monitored and altered as clinically appropriate based on institutional guidelines. Patients will be eligible for MMF dosing and pharmacokinetics studies.
Stop MMF at Day +30 or 7 days after engraftment, whichever day is later, if no acute graft versus host disease (GVHD). (Definition of engraftment is 1st day of 3 consecutive days of absolute neutrophil count [ANC) ≥ 0.5 x 109 /L]). If no donor engraftment, do not stop MMF.
 Type: Drug
Group Labels:  2  ATG  No ATG  
 Name: Sirolimus
Description: Both Arms:
Adult Dosing: Sirolimus will be administered starting at Day -3 with 8-12 mg oral loading dose followed by single dose 4 mg/day with a target serum concentration of 3 to 12 mg/mL by high-performance liquid chromatography (HPLC) and will be monitored per institutional guidelines. In the absence of acute GVHD sirolimus may be tapered starting at Day +100 and eliminated by Day +180 post-transplantation.
Pediatric Dosing: Sirolimus will be administered starting on Day -3 with an oral loading dose of 10 mg followed by maintenance dosing of 2.5 mg/m^2/day (Maximum total daily dose of 4mg) as per institutional guidelines. Target serum concentration goals are 3 to 12 mg/mL by high-performance liquid chromatography (HPLC) and will be monitored per institutional guidelines.
 Type: Drug
Group Labels:  2  ATG  No ATG  
 Name: TBI
Description: Both Arms: 200 cGy on Day -1
 Type: Radiation
Group Labels:  2  ATG  No ATG  
 Name: Umbilical cord blood cell infusion
Description: Both Arms: Day 0
 Type: Biological
Group Labels:  2  ATG  No ATG  
 Name: ATG
Description: Arm 2: 15 mg/kg IV every 12 hours Day -6 to Day -4
 Type: Biological
  Primary Outcomes 
 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 100
    Secondary Outcomes 
 Description: Percentage of patients with grade III-IV acute GVHD.
 Measure: Incidence of Acute GVHD
 Time: Day 100
 Measure: Transplant related mortality
 Time: 6 months post transplant
 Description: Percentage of subjects with donor chimerism.
 Measure: Chimerism
 Time: Day 21
 Description: Percentage of subjects with donor chimerism.
 Measure: Chimerism
 Time: Day 100
 Description: Percentage of subjects with donor chimerism.
 Measure: Chimerism
 Time: Day 180
 Description: Percentage of subjects with donor chimerism.
 Measure: Chimerism
 Time: 1 year post transplant
 Description: Percentage of subjects with neutrophil engraftment.
 Measure: Neutrophil Engraftment
 Time: Day 42
  
Purpose: Treatment
Allocation: Non-Randomized
Parallel Assignment 
There is one SNP
SNPs
1 T315I 
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 ---