Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-25 @ 2:32 PM
NCT ID:
NCT02500550
Group ID:
EG000
Title:
ATIR101
Description:
ATIR101: T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment). Two intravenous infusions with 2x10E6 viable T-cells/kg approximately 42 days apart (unless the second dose is reduced or halted for safety reasons).
Haploidentical hematopoietic stem cell transplantation (HSCT): CD34-selected HSCT from a haploidentical donor. In order to prepare the patient for the HSCT one of the following myeloablative conditioning regimens is recommended:
* Total Body Irradiation (TBI) regime
* Non-TBI regime
(See below for details)
TBI regime: • Fractionated TBI 200 cGy twice daily for 3 days on Day -10 to -8 (1200 cGy in 6 fractions)
* Fludarabine 30 mg/m2 IV once daily for 5 days on Day -7 to -3
* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7
* Anti-thymocyte globulin (ATG; Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.
Non-TBI regime: • Fludarabine; 30 mg/m2 IV once daily for 5 days on Day -8 to -4
* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7
* Melphalan; 60 mg/m2 IV once daily for 2 days on Day -2 and -1
* ATG (Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.
Deaths Number Affected:
7
Deaths Number At Risk:
None
Serious Number Affected:
7
Serious Number At Risk:
15
Other Number Affected:
8
Other Number At Risk:
15
Study:
NCT02500550
Results Section:
NCT02500550
Adverse Events Module:
NCT02500550