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BMT for Refractory SLE
NCT02080195Phase 2
Key facts
- Status
- Terminated
- Start
- Sep 2016
- Primary completion
- Mar 2017
- Countries
- 1
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center
- Modality
- Monoclonal Antibodies, Stem Cell Therapies, Small Molecules
- Drugs
- Allogeneic Bone Marrow Transplant-Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins-B-cell lymphoma-chronic lymphocytic leukemia
- Conditions
- systemic lupus erythematosus (SLE)
01
Overview
Phase 2, open-label, single-arm trial of Allogeneic Bone Marrow Transplant-Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins-B-cell lymphoma-chronic lymphocytic leukemia in systemic lupus erythematosus (SLE), sponsored by Sidney Kimmel Comprehensive Cancer Center. Primary endpoint: Feasibility of the Conditioning Regimen and Post Transplantation Cyclophosphamide at 1 year. Started Sep 2016; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Nonmyeloablative Conditioning and BMT
Experimental arm receiving conditioning followed by allogeneic BMT and GVHD prophylaxis.
03
Who it enrols
Patients with refractory SLE (meeting ACR or SLICE criteria) with organ involvement who failed corticosteroids and at least one other immunosuppressant.
04
Endpoints
Primary
Feasibility of the Conditioning Regimen and Post Transplantation Cyclophosphamide
Secondary
RIFLE Score
Survival
Graft Failure
Acute Graft Versus Host Disease
Chronic Graft Versus Host Disease
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