Adoptive TReg Cell for Suppression of aGVHD After UCB HSCT for Heme Malignancies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02991898|
Recruitment Status : Terminated (Considering new technology for product.)
First Posted : December 14, 2016
Results First Posted : July 24, 2020
Last Update Posted : September 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia Burkitt Lymphoma Natural Killer Cell Malignancies Chronic Myelogenous Leukemia Myelodysplastic Syndromes Large-cell Lymphoma Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Marginal Zone B-Cell Lymphoma Follicular Lymphoma Lymphoplasmacytic Lymphoma Mantle-Cell Lymphoma Prolymphocytic Leukemia Hodgkin Lymphoma Multiple Myeloma Acute Myelogenous Leukemia Biphenotypic Leukemia Undifferentiated Leukemia||Biological: Infusion of Treg||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adoptive Transfer of T Regulatory Cell for Suppression of Acute Graft-vs-Host-Disease After an Umbilical Cord Blood Transplant for Hematologic Malignancies|
|Actual Study Start Date :||February 16, 2017|
|Actual Primary Completion Date :||June 20, 2019|
|Actual Study Completion Date :||June 20, 2019|
Experimental: Treg Infusion
The Treg cell infusion is given no sooner than 1 hour, but within 24 hours after the 2nd cord blood infusion
Biological: Infusion of Treg
Allopurinol on day -7 to day 0 Cyclophosphamide 50 mg/kg IV over 2 hours on day -6 Fludarabine 30mg/m2 IV over 1 hour on day -6, -5, -4, -3, and -2 Total Body Irradiation 200 cGy as a single dose
Sirolimus 8mg-12mg oral loading dose followed by single dose 4mg/day. Levels are to be monitored 3 times/week in the first week, weekly until day +60, and as clinically indicated until day +100 post-transplantation.
Mycophenolate Mofetil (MMF) 3 gram/day IV/PO divided in 2 or 3 doses. Stop MMF at day +30 or 7 days after neutrophil recovery, whichever day is later, if no acute GVHD.
DUCBT followed Tregs - double umbilical cord blood transplant (FIRST) followed by the Treg cell infusion (SECOND) no sooner than 1 hour, but within 24 hours after the 2nd cord blood infusion.
Other Name: T regulatory cells
- Number of Participants Survived [ Time Frame: 2 years ]Count of patients who survived 2 years post intervention
- Number of Participants With Grade II-IV aGVHD [ Time Frame: Assessed weekly until day 100, then day 180, 360 ]Probability of grade II-IV aGVHD
- Number of Participants Experiencing Treatment Related Mortality (TRM) [ Time Frame: 6 months ]Evaluated with descriptive statistics and plots or cumulative incidence curves if enough evaluable patients are available for time-to-event endpoints.
- Number of Participants Who Experienced Relapse [ Time Frame: 1 year ]Evaluated with descriptive statistics and plots or cumulative incidence curves if enough evaluable patients are available for time-to-event endpoints.
- Number of Participants With Incidence of Bacterial, Viral and Fungal Infections [ Time Frame: 1 year ]Evaluated with descriptive statistics and plots or cumulative incidence curves if enough evaluable patients are available for time-to-event endpoints.
- Number of Participant With Detectable Treg Cells at d14 [ Time Frame: 14 days ]The proportion of patients with detectable Treg cells at day 14 post infusion
- Number of Participants With Immune Reconstitution [ Time Frame: Assessed at Day 4, weekly for 8 weeks ]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.
- Number of Participants Experiencing Treg Cell Infusion Toxicity [ Time Frame: 48 hours post infusion ]Incidence of Adverse Events
- Length of Treg Survival [ Time Frame: 24 hours post infusion ]Length of Treg survival after infusion of Treg.
- Percentage of Donor Cell Chimerism [ Time Frame: Day +100 ]The incidence of chimerism in patients treated
- Number of Participants Survived One Year Post-transplant [ Time Frame: 1 year ]The probability of survival, one year post-treatment
- Number of Participants With Neutrophil Recovery [ Time Frame: Day 42 ]The incidence of neutrophil recovery, that is return of neutrophil counts to ≥ 5 X 10^8/L in treated patients
- Number of Participants With Platelet Recovery [ Time Frame: 1 year ]The incidence of platelet recovery (return of platelet counts to > 20,000/μL) in treated patients
- Number of Participants With Chronic GVHD [ Time Frame: 1 year ]The incidence of chronic GVHD in treated patients after one year
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991898
|United States, Minnesota|
|Masonic Cancer Center at University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Claudio Brunstein, MD, PhD||Masonic Cancer Center, University of Minnesota|