This is a single center pilot study of a non-myeloablative umbilical cord blood transplant for the treatment of a hematological malignancy with a single infusion of T regulatory (Treg) given shortly after UCB transplantation.
Name: Infusion of Treg
Description: Measured by the length of Treg survival after infusion of Treg
Measure: Efficacy of Intervention Time: 2 yearsDescription: Probability of grade II-IV aGVHD
Measure: Grade II-IV aGVHD Time: Assessed weekly until day 100, then day 180, 360Description: Probability of grade III-IV aGVHD
Measure: Grade III-IV aGVHD Time: Assessed weekly until day 100, then day 180, 360Description: Evaluated with descriptive statistics and plots or cumulative incidence curves if enough evaluable patients are available for time-to-event endpoints.
Measure: Treatment related mortality (TRM) Time: 6 monthsDescription: Evaluated with descriptive statistics and plots or cumulative incidence curves if enough evaluable patients are available for time-to-event endpoints.
Measure: Relapse Time: 1 yearDescription: Evaluated with descriptive statistics and plots or cumulative incidence curves if enough evaluable patients are available for time-to-event endpoints.
Measure: Incidence of viral and fungal infections Time: 1 yearDescription: The proportion of patients with detectable Treg cells at day 14 post infusion
Measure: Detectable Treg cells Time: Day 14Description: The proportion of patients with immune reconstitution. Continuous endpoints will be described by medians, ranges and interquartile ranges as well as means and standard deviations if normally distributed.
Measure: Immune reconstitution Time: Assessed at Day 4, weekly for 8 weeksDescription: Incidence of Adverse Events
Measure: Treg Cell Infusion Toxicity Time: 48 hours post infusionDescription: Length of Treg survival after infusion of Treg.
Measure: Treg Survival Time: 24 hours post infusionDescription: The incidence of chimerism in patients treated
Measure: Chimerism Time: Day +100Description: The probability of survival, one year post-treatment
Measure: Survival Time: 1 yearDescription: The incidence of neutrophil recovery in treated patients
Measure: Neutrophil Recovery Time: Day 42Description: The incidence of platelet recovery in treated patients
Measure: Platelet Recovery Time: 1 yearDescription: The incidence of chronic GVHD in treated patients after one year
Measure: Chronic GVHD Time: 1 yearAllocation: N/A
Single Group Assignment
There is one SNP
Chronic phase patients must have failed at least two different tyrosine-kinase inhibitors (TKIs), or been intolerant to all available TKIs or have T315I mutation. --- T315I ---