Georgia's Online Cancer Information Center

Find A Clinical Trial

A Study of Tolinapant in Combination With Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma (R/R PTCL)

Status
Closed
Cancer Type
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05403450
Protocol IDs
ASTX660-03 (primary)
NCI-2022-10432
2021-005338-40
Study Sponsor
Astex Pharmaceuticals, Inc.

Summary

The primary purpose of the study is to assess safety, and to identify the recommended phase 2
dose (RP2D) of tolinapant in combination with oral decitabine/cedazuridine in Phase 1 and to
assess preliminary efficacy as determined by overall response rate (ORR) in Phase 2.

Eligibility

  1. Participants with expected life expectancy of >12 weeks.
  2. Participants must have histologically confirmed R/R PTCL (local pathology report) as defined by 2016 World Health Organization (WHO) classification. The following subtypes are eligible for the study:
  3. Extranodal natural killer (NK)/T-cell lymphoma nasal type.
  4. Enteropathy-associated T-cell lymphoma.
  5. Monomorphic epitheliotropic intestinal T-cell lymphoma.
  6. Hepatosplenic T-cell lymphoma.
  7. Subcutaneous panniculitis-like T-cell lymphoma.
  8. Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS).
  9. Angioimmunoblastic T-cell lymphoma.
  10. Follicular peripheral T-cell lymphoma.
  11. Nodal peripheral T-cell with T-follicular helper (THF) phenotype.
  12. Anaplastic large-cell lymphoma (ALCL).
  13. Participants must have evidence of progressive disease and must have received at least two prior systemic therapies.
  14. Participants must have measurable disease by contrast-enhanced diagnostic CT (at least 1 nodal lesion >1.5 centimeters (cm) or extranodal lesions >1.0 cm).
  15. Participants with CD30-positive disease must have received, be ineligible for, or intolerant to brentuximab vedotin.
  16. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  17. Acceptable organ function as per protocol.
  18. Women of childbearing potential (according to recommendations of the Clinical Trial Facilitation Group [CTFG]) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
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.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.