drugset / Trial / NCT00524784

Open-Label Study Designed to Evaluate the Safety and Preliminary Efficacy of ApoCell for the Prevention of Acute GvHD

NCT00524784 ↗

Phase 1/2 Unknown 12 enrolled Hadassah Medical Organization
Non-randomizedSingle-groupOpen-labelPrevention

Summary

Bone marrow transplantation (BMT) has revolutionized the treatment of hematopoietic malignancies.Unfortunately, graft versus host disease (GvHD) remains a major toxicity that greatly limits the application and efficacy of BMT.Current standard prophylaxis and therapy for acute GvHD include mainly the use of immunosuppressive drugs that help less than 50% of the patients and are associated with increased infection risk. ApoCell treatment is anticipated to be a prophylactic measure for acute GvHD by inducing tolerance in the donor effector cells, leading to a potentially significant decrease in GVHD.

Timeline

Start
2009-06
Primary completion
2012-12
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Subject ApoCell Cell therapy 35 cells/kg Intravenous
Subject ApoCell Cell therapy 70 cells/kg Intravenous
Subject ApoCell Cell therapy 140 cells/kg Intravenous
Subject ApoCell Cell therapy 210 cells/kg Intravenous