Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
211^At-BC8-B10 Before Stem Cell Transplant for High-Risk Leukemias and MDS
NCT03128034Phase 2
Key facts
- Status
- Recruiting
- Start
- Oct 2017
- Primary completion
- Jun 2027
- Countries
- 1
- Sponsor
- Fred Hutchinson Cancer Center
- Modality
- Monoclonal Antibodies
- Drugs
- [211At]BC8-B10
- Conditions
- acute myeloid leukemia (AML)acute lymphoblastic leukemia (ALL)myelodysplastic syndrome (MDS)mixed phenotype acute leukemia (MPAL)
01
Overview
Phase 2, open-label, single-arm trial of [211At]BC8-B10 in acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS) and 1 more, sponsored by Fred Hutchinson Cancer Center. Primary endpoint: Incidence of dose limiting toxicity at 60 days. Started Oct 2017; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Treatment (211^At-BC8-B10, PBSC)
Patients receive 211^At-BC8-B10, fludarabine, TBI, PBSC transplant, and GVHD prophylaxis.
03
Who it enrols
Adult patients (18-75) with high-risk AML, ALL, MDS, or MPAL, with adequate organ function and an HLA-matched donor, excluding those with severe cardiac/pulmonary/hepatic dysfunction, HIV, or prior myeloablative transplant.
04
Endpoints
Primary
Incidence of dose limiting toxicity
Secondary
Engraftment
Chimerism
Non-relapse mortality
Acute graft versus host disease
Achievement of remission
Duration of remission
Overall survival
Disease-free survival
Beyond the preview
Go deeper on NCT03128034.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT03128034.