PI3Kδ Inhibitor Parsaclisib Combined With Chidamide for the Treatment of Relapsed/Refractory Peri… (NCT05083208) | Clinical Trial Compass
TerminatedPhase 1
PI3Kδ Inhibitor Parsaclisib Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma
Stopped: The clinical development of parsaclisib was stopped by it's manufacturer.
China12 participantsStarted 2022-02-20
Plain-language summary
This is a prospective single-arm, multicenter, phase Ib clinical trial of PI3Kδ inhibitor Parsaclisib combined with chidamide for the treatment of relapsed/refractory peripheral T-cell lymphoma.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age between 18 to 75 years old (including 18 and 75)
✓. Agreeing to sign the written informed consents
✓. 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
✓. Received at least first-line anti-tumor therapy in the past, whether or not Chidamide has been used
✓. Having at least one measurable lesions
✓. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2
✓. Life expectancy no less than 3 months
✓. enough main organ function
Exclusion criteria
✕. Types other than peripheral T-cell lymphoma listed in the enrollment criteria
✕. Diagnosed as central nervous system lymphoma
✕. Received palliative treatment for other malignant tumors in the past 2 years
✕. Uncontrolled active infection
What they're measuring
1
Safety and Tolerability of Parsaclisib in Combination with Chidamide
Timeframe: Approximately 2 years
2
Recommended Phase 2 Dose (RP2D) of Parsaclisib in Combination with Chidamide
. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
✕. 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
✕. Patients with a history of mental illness
✕. Those who are known to be allergic to the active ingredients or excipients of the drug parsaclisib and chidamide