A Study of the Effects of AB-205 in Patients With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation
NCT05181540 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130
Last updated 2025-02-04
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
- BIOLOGICAL
-
AB-205
Allogeneic genetically engineered human umbilical vein endothelial cells
- OTHER
-
Placebo
Placebo
Sponsors & Collaborators
-
California Institute for Regenerative Medicine (CIRM)
collaborator OTHER -
Angiocrine Bioscience
lead INDUSTRY
Principal Investigators
-
Paul Finnegan, MD · Angiocrine Bioscience, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-21
- Primary Completion
- 2023-12-29
- Completion
- 2025-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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