PI3Kδ Inhibitor Parsaclisib Combined with Chidamide for the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma

Launched by HENAN CANCER HOSPITAL · Oct 17, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with relapsed or refractory peripheral T-cell lymphoma, a type of cancer that affects the immune system. The trial is testing a combination of two medications: Parsaclisib, which is designed to block a specific pathway that helps cancer cells grow, and Chidamide, which is a type of treatment that works on the immune system. The goal is to see how well this combination works in helping patients whose cancer has not responded to other treatments.

To be eligible for this trial, participants should be between 18 and 75 years old and must have been diagnosed with one of the specific types of peripheral T-cell lymphoma. They should have already received at least one round of treatment for their cancer and have measurable signs of the disease. Participants will need to provide informed consent, which means they agree to follow the study rules and understand what the trial involves. Throughout the trial, participants will receive regular check-ups and monitoring to assess their health and the effectiveness of the treatment. It's important for potential participants to discuss with their doctors to see if this trial is a suitable option for them.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 to 75 years old (including 18 and 75)
• • 2. Agreeing to sign the written informed consents
• • 3. Diagnosed as peripheral T-cell lymphoma, including peripheral T-cell lymphoma, unspecified type, anaplastic large cell lymphoma (ALK negative or positive), angioimmunoblastic T-cell lymphoma, enteropathy Related T-cell lymphoma, hepatosplenic T-cell lymphoma, γ/δ T-cell lymphoma, NK/T-cell lymphoma, and other subtypes of PTCL that the investigator judges to be suitable for participating in this study
• • 4. Received at least first-line anti-tumor therapy in the past, whether or not Chidamide has been used
• • 5. Having at least one measurable lesions
• • 6. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2
• • 7. Life expectancy no less than 3 months
• • 8. enough main organ function
• • 9. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
• • 10. Agreeing to follow the trail protocol requirements
• Exclusion Criteria:
• • 1. Types other than peripheral T-cell lymphoma listed in the enrollment criteria
• • 2. Diagnosed as central nervous system lymphoma
• • 3. Received palliative treatment for other malignant tumors in the past 2 years
• • 4. Uncontrolled active infection
• • 5. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
• • 6. The non-hematological toxicity caused by the previous anti-tumor treatment has not recovered to ≤1 grade, and the hematological toxicity has not recovered to ≤2 grade
• • 7. Patients with a history of mental illness
• • 8. Those who are known to be allergic to the active ingredients or excipients of the drug parsaclisib and chidamide
• • 9. Received PI3Kδ inhibitor treatment in the past
• • 10. Received autologous hematopoietic or allogeneic hematopoietic stem cell transplantation within 3 months
• • 11. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) \>2
• • 12. There are factors that affect the absorption of oral drugs
• • 13. Pregnant or lactating women
• • 14. Researchers determine unsuited to participate in this trial