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Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma

Status
Active
Cancer Type
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05079282
Protocol IDs
ONO-4685-03 (primary)
NCI-2022-03223
Study Sponsor
Ono Pharmaceutical Company Limited

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

  1. Patients aged = 18 years at time of screening
  2. Written informed consent by the patient or the patients' legally authorized representative prior to screening
  3. Patients with histologically or cytologically confirmed diagnosis of one of the following subtypes of T-cell lymphoma:
  4. Peripheral T-cell lymphoma (PTCL): Angioimmunoblastic T-cell lymphoma (AITL), PTCL, not otherwise specified (PTCL-NOS), nodal PTCL with T-follicular helper (TFH) and follicular T-cell lymphoma (FTCL)
  5. Cutaneous T-cell lymphoma (CTCL) (stages II-B, III, and IV): Mycosis fungoides (MF) and Sezary syndrome (SS)
  6. Patients must have received at least 2 prior systemic therapies
  7. Patients with PTCL must have at least 1 measurable lesion (Cheson BD, 2014)
  8. Patients with CTCL must have assessable disease by response criteria for CTCL (Olsen EA, 2011)
  9. Eastern Cooperative Oncology Group Performance Status (ECOG PS) = 0-2
  10. Life expectancy of at least 3 months
  11. Adequate bone marrow, renal and hepatic functions

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.