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 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:40 PM
NCT ID:
NCT05579769
Group ID:
EG000
Title:
TBI/Cy Regimen
Description:
Patients with lymphoid malignancies will receive Total Body Irradiation (TBI)/Cyclophosphamide (Cy).
Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries.
Participants receive 8 doses TBI. Cyclophosphamide, IV. Rabbit ATG, IV. Males with lymphoid lineage leukemia will receive an additional testicular boost concurrent with TBI.
Patients who receive a bone marrow product from MSD will not receive rATG.
G-CSF: Use of GCSF is not recommended except after day +21 when a single dose not exceeding 2.5mcg/kg may be given after rounding off if APC is \>500 cells/mm3, and ANC is\<500 cells/mm3 to mobilize cells.
Mesna: Mesna will be given IV approximately 15 minutes prior to each dose of cyclophosphamide and approximately 3, 6, 9, and 12 hours after each dose of cyclophosphamide.
GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG.
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
2
Serious Number At Risk:
2
Other Number Affected:
2
Other Number At Risk:
2
Study:
NCT05579769
Results Section:
NCT05579769
Adverse Events Module:
NCT05579769