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Report for Clinical Trial NCT02722668
Developed by Shray Alag, 2020.
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 ---