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: Count of patients who survived 2 years post intervention
Measure: Number of Participants Survived Time: 2 yearsDescription: Probability of grade II-IV aGVHD
Measure: Number of Participants With Grade II-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: Number of Participants Experiencing 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: Number of Participants Who Experienced 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: Number of Participants With Incidence of Bacterial, Viral and Fungal Infections Time: 1 yearDescription: The proportion of patients with detectable Treg cells at day 14 post infusion
Measure: Number of Participant With Detectable Treg Cells at d14 Time: 14 daysDescription: 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: Number of Participants With Immune Reconstitution Time: Assessed at Day 4, weekly for 8 weeksDescription: Incidence of Adverse Events
Measure: Number of Participants Experiencing Treg Cell Infusion Toxicity Time: 48 hours post infusionDescription: Length of Treg survival after infusion of Treg.
Measure: Length of Treg Survival Time: 24 hours post infusionDescription: The incidence of chimerism in patients treated
Measure: Percentage of Donor Cell Chimerism Time: Day +100Description: The probability of survival, one year post-treatment
Measure: Number of Participants Survived One Year Post-transplant Time: 1 yearDescription: The incidence of neutrophil recovery, that is return of neutrophil counts to ≥ 5 X 10^8/L in treated patients
Measure: Number of Participants With Neutrophil Recovery Time: Day 42Description: The incidence of platelet recovery (return of platelet counts to > 20,000/μL) in treated patients
Measure: Number of Participants With Platelet Recovery Time: 1 yearDescription: The incidence of chronic GVHD in treated patients after one year
Measure: Number of Participants With 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 ---