drugset / Trial / NCT02462252
Phase IIA Open Label Study to Evaluate Efficacy and Safety of BL-8040 Followed by (hATG), Cyclosporine and Methyprednisolone in Adult Subjects With Aplastic Anemia or Hypoplastic Myelodysplastic Syndrome
NaSingle-groupOpen-labelTreatment
Summary
An open label single arm study to assess efficacy and safety of BL-8040 on top of standard immunotherapy regimen of hATG, cyclosporine and steroids in patients with Hypoplastic MDS and AA over the course of a six month (180 day) treatment period.
Timeline
- Start
- 2015-10
- Primary completion
- 2020-11
- Completion
- 2020-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Motixafortide | Peptide | 0.75 mg/kg | Subcutaneous |
| Background | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 35 mg/kg | Intravenous |
| Background | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 40 mg/kg | Intravenous |
| Background | Cyclosporine | Peptide | 5 mg/kg | Oral |
| Background | Methylprednisolone | Other / unclassified | 35 mg/kg | Intravenous |
| Background | Methylprednisolone | Other / unclassified | 40 mg/kg | Intravenous |