Trial of AB-205 in Adults With Lymphoma Undergoing High-Dose Therapy and Autologous Stem Cell Transplantation
- Conditions
- Hodgkin LymphomaNon-hodgkin Lymphoma
- Interventions
- Biological: AB-205
- Registration Number
- NCT03925935
- Lead Sponsor
- Angiocrine Bioscience
- Brief Summary
A phase 1, open label, multi-center trial of AB-205 in adults with Hodgkin or non-Hodgkin lymphoma who are in chemo-sensitive remission undergoing high-dose therapy, with or without radiation, and autologous stem cell transplantation (HDT-ASCT). Subjects will receive AB-205 infusion following autologous stem cell transfusion on Day 0.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Experimental AB-205 Up to 3 sequential dose escalation cohorts of AB-205
- Primary Outcome Measures
Name Time Method Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5 24 hours
- Secondary Outcome Measures
Name Time Method Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5 100 days Overall survival 100 and 365 days post-ASCT Time to lymphoid recovery 14, 28 and 100 days post-ASCT Time to platelet engraftment First of seven consecutive days after ASCT of platelet count ≥ 20,000/μL without transfusion support Severity and duration of grade ≥ 3 mucosal toxicities including oropharyngeal mucositis, nausea, vomiting, and/or diarrhea. Day 0 to hospital discharge Time to neutrophil engraftment First of three consecutive days after ASCT of absolute neutrophil count (ANC) > 500/μL Progression-free survival 100 and 365 days post-ASCT Non-relapse mortality 100 and 365 days post-ASCT
Trial Locations
- Locations (9)
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
The University of California San Francisco
🇺🇸San Francisco, California, United States
UC Davis Comprehensive Cancer Center
🇺🇸Sacramento, California, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
MD Anderson
🇺🇸Houston, Texas, United States
UC San Diego Moores Cancer Center
🇺🇸San Diego, California, United States