Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma
Condition(s) studied
Investigational drug(s) / intervention(s)
ONO-4685: ONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued until disease progression or unacceptable toxicity is observed
Study summary
This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 in patients with relapsed or refractory T cell Lymphoma
Eligibility
Primary outcome measure(s)
- Incidence, nature, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs). — Through study completion, an average of 1 year
Adverse events with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 used as a guide for the grading of severity. - Estimate of Maximum Tolerate Dose (MTD) — Up to 3 weeks
MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | |
| City of Hope | Duarte | California | |
| University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center | Orange | California | |
| Stanford Cancer Institute | Palo Alto | California | |
| Yale Cancer Center | New Haven | Connecticut | |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | |
| Dana Farber Cancer Institute | Boston | Massachusetts | |
| Karmanos Cancer Institute | Detroit | Michigan | |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | |
| Hackensack University Medical Center - John Theurer Cancer Center | Hackensack | New Jersey | |
| Roswell Park Cancer Institute | Buffalo | New York | |
| New York-Presbyterian/Columbia University Irving Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC) | New York | New York | |
| Memorial Sloan-Kettering Cancer Center | New York | New York | |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | |
| Cleveland Clinic | Cleveland | Ohio | |
| Oregon Health & Science University | Portland | Oregon | |
| University of Pennsylvania - Perelman Center | Philadelphia | Pennsylvania | |
| Vanderbilt University - Ingram Cancer Center | Nashville | Tennessee | |
| UT Southwestern Medical Center | Dallas | Texas | |
| MD Anderson | Houston | Texas | |
| Fred Hutchinson Cancer Center | Seattle | Washington |
More Ono Pharmaceutical Co., Ltd. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05079282 on ClinicalTrials.gov ↗ ← All trials in the USA