NCT05181540

A Study of the Effects of AB-205 in Patients With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation

A Phase 3 Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of AB-205 Plus Standard of Care Versus Placebo Plus Standard of Care in Adults With Lymphoma Undergoing High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (HDT-AHCT) (E-CELERATE)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Angiocrine Bioscience · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

High-dose chemotherapy followed by blood stem cell transplantation is administered to lymphoma patients with an intention to cure. However, high-dose chemotherapy simultaneously causes damage to healthy tissues that frequently result in severe complications that lead to hospitalization and can be life threatening. These severe complications involve the blood, immune, gastro-intestinal systems, and other vital organs. The purpose of this study is to determine if experimental therapy AB-205 (study drug) can prevent or reduce the occurrence and duration of the severe chemotherapy related complications when compared to placebo in patients with lymphoma undergoing treatment with high-dose chemotherapy and blood stem cell transplantation. All patients, whether treated with AB-205 or placebo, will receive standard preventive and supportive care therapies.

Conditions

• Hodgkin Lymphoma
• Non Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	AB-205	Allogeneic genetically engineered human umbilical vein endothelial cells
OTHER	Placebo	Placebo

Timeline

• Start date: 2022-02-21
• Primary completion: 2023-12-29
• Completion: 2025-01-31
• First posted: 2022-01-06
• Last updated: 2025-02-04

Locations

28 sites across 1 country: United States

Regulatory

• FDA-regulated drug study