This study was designed to evaluate the safety and tolerability of HSC835 for clinical use as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA) conditioning.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
9
HSC835 is a stem cell therapy product providing a source of Hematopoietic stem cell (HSC).
Novartis Investigative Site
Minneapolis, Minnesota, United States
Absence of Graft Failure at Day 42
This endpoint was to study safety and tolerability of HSC835 as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA) conditioning.
Time frame: 42 days
Incidence of Neutrophil Recovery Within 42 Days
Engraftment is defined as the first of three consecutive days with ANC \> 0.5 x 109/L.
Time frame: 42 days
Incidence of Non-relapse Mortality (NRM) Within 100 Days and One Year
NRM includes all patients who died from any other cause except relapse of the underlying disease during the study duration.
Time frame: 1 year
Incidence of Overall Survival Within One Year
Overall survival is the proportion of patients who were alive at the end of the one year study period.
Time frame: 1 year
Incidence of Relapse-free Survival Within One Year
Patients are considered to have achieved relapse-free survival if they had not experienced either relapse or death (of any cause) at the end of the study.
Time frame: 1 year
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