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:
EG001
Title:
TBF Regimen
Description:
Patients with myeloid, bi-phenotypic, bilineage or undifferentiated leukemia will receive thiotepa, busulfan, and fludarabine (TBF). Patients will receive TBF regimen when TBI is not appropriate.
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 Thiotepa, IV. Busulfan, IV. Fludarabine, IV. Rabbit ATG, IV.
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.
Levetiracetam IV will be prescribed as seizure prophylaxis for recipients receiving busulfan.
GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
1
Other Number Affected:
1
Other Number At Risk:
1
Study:
NCT05579769
Results Section:
NCT05579769
Adverse Events Module:
NCT05579769