Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT04615468
Eligibility Criteria:
Inclusion Criteria:
* 1\. Understood and signed an informed consent form; 2. 18 years and older, Eastern Cooperative Oncology Group(ECOG) performance status score of 0 to 2, life expectancy ≥ 3 months; 3. Diagnosis of peripheral T-cell lymphoma (PTCL); 4. Has received at least one line systemic treatment and disease progression after the last treatment; 5. Has at least one measurable lesion; 6. Adequate organ system function; 7. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration.
Exclusion Criteria:
* 1\. Other types of T-cell lymphoma; 2. Has central nervous system violation; 3. Has received other PI3K inhibitors or CAR-T treatments; 4. Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration; 5. Has type I diabetes or uncontrolled type II diabetes; 6. Has history of interstitial lung disease; 7. Has history of interstitial lung disease; 8. Has multiple factors affecting oral medication; 9. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1; 10. Has received systemic steroid treatment within 7 days before the first dose; 11. Has received other systemic anti-tumor medications within 4 weeks before the first administration, or still within the 5 half-life of the medication, which occurs first; 12. Has active infections which need drug treatment; 13. Has received surgery, or unhealed wounds within 4 weeks before the first administration; 14. Has a history of autologous hematopoietic stem cell transplant within 3 months; 15. Has a history of allogeneic hematopoietic stem cell transplant; 16. Grade II or higher cardiovascular disease within 6 months before the first administration; 17. QTCF \> 480ms, left ventricular ejection fraction (LVEF)\<50%; 18. Urinary protein ≥ 2 +, and 24-hour urinary protein quantity\>1g within 7 days; 19. Has active hepatitis B or C; 20. Has psychotropic substances abuse or a mental disorder; 21.Has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04615468
Study Brief:
Protocol Section:
NCT04615468