NCT03357159

Anti T-lymphocyte Immunoglobulin With Post Transplant Cyclophosphamide to Prevent GVHD Post Allogeneic Transplantation

A Phase II Study of Neovii Anti-human T-lymphocyte Immunoglobulin (ATLG, Grafalon®) With Post Transplant Escalated Doses of Post-transplant-Cyclophosphamide to Prevent Acute and Chronic GVHD Post Allogeneic Stem Cell Transplantation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Investigators hypothesize that combination of ATLG with PTCy in matched or mismatched unrelated hematopoietic stem cell transplantation will reduce acute and chronic GVHD incidence. Furthermore it will allow shortening of the length of post-transplantation immunosuppression with calcineurin inhibitor (CNI) administration (currently administrated in addition to ATG as GVHD prophylaxis in daily common practice)

Conditions

• Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	In the first phase escalated doses of post-transplant cyclophosphamide up to a maximal dose of 50 mg/kg , the second phase will use the MTD cyclophosphamide dose identified in the first phase.
DRUG	anti-human T-lymphocyte immunoglobulin (ATLG)	15mg/kg total (5mg/kg day) on days -3 to -1 pre transplantation

Timeline

• Start date: 2018-09-06
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2017-11-29
• Last updated: 2023-11-28

Locations

1 site across 1 country: Israel