Clinical Trial
Phase 1b/2a Evaluation of the Safety and Tolerability of SYN-004 in Adult Allogeneic Hematopoietic Cell Transplantation (Allo-HCT) Recipients
Cancer Type
Leukemia, Myeloma, and Hematologic
Protocol Number
202011117
Principal Investigator
Learn more about this study at
clinicaltrials.gov
For more information contact us here:
Phone
800-600-3606Brief Summary
Study Objectives:
1. To evaluate the safety and tolerability of oral SYN-004 in adult allogeneic HCT (allo-HCT) recipients who develop fever after conditioning therapy and are treated with IV β-lactam antibiotics meropenem (MER), piperacillin tazobactam (PIP/TAZO), or cefepime (FEP).
2. To evaluate potential absorption of oral SYN-004 into the systemic circulation of allo-HCT recipients and potential SYN-004-mediated alterations to systemic levels and efficacy of IV MER, PIP/TAZO or FEP.
3. To evaluate potential protective effects of SYN-004 on the intestinal microbiome of allo-HCT recipients treated with IV MER, PIP/TAZO or FEP.
4. To obtain preliminary information on potential therapeutic benefits and patient outcomes of SYN-004 in allo-HCT recipients treated with IV MER, PIP/TAZO or FEP
Protocol Interventions
Biological: SYN-004, Ribaxamase or Placebo
Learn About Clinical Trials
Clinical trials are research studies that help us find new ways to prevent, diagnose, and treat cancer. If you are interested in participating in a clinical trial, our team will help you find a study that is right for you. Call us to speak with a Siteman care coordinator.