Adoptive TReg Cell for Suppression of aGVHD After UCB HSCT for Heme Malignancies
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|ClinicalTrials.gov Identifier: NCT02991898|
Recruitment Status : Suspended (Safety)
First Posted : December 14, 2016
Last Update Posted : March 29, 2018
|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)|
|Estimated Enrollment :||10 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|
|Estimated Primary Completion Date :||January 2025|
|Estimated Study Completion Date :||January 2025|
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 signle 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
- Efficacy of Intervention [ Time Frame: 2 years ]Measured by the length of Treg survival after infusion of Treg
- Grade II-IV aGVHD [ Time Frame: Assessed weekly until day 100, then day 180, 360 ]Probability of grade II-IV aGVHD
- Grade III-IV aGVHD [ Time Frame: Assessed weekly until day 100, then day 180, 360 ]Probability of grade III-IV aGVHD
- 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.
- 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.
- Incidence of 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.
- Detectable Treg cells [ Time Frame: Day 14 ]The proportion of patients with detectable Treg cells at day 14 post infusion
- 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.
- Toxicity [ Time Frame: 48 hours post infusion ]Toxicity and adverse events will be classified according to NCI's Common Terminology Criteria for Adverse Events V 4.0 (CTCAE).
- Treg Survival [ Time Frame: 24 hours post infusion ]Length of Treg survival after infusion of Treg.
- Chimerism [ Time Frame: Day +100 ]The incidence of chimerism in patients treated
- Survival [ Time Frame: 1 year ]The probability of survival, one year post-treatment
- Neutrophil Recovery [ Time Frame: Day 42 ]The incidence of neutrophil recovery in treated patients
- Platelet Recovery [ Time Frame: 1 year ]The incidence of platelet recovery in treated patients
- 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|