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

Henan Cancer Hospital

Status and phase: Terminated; Phase 1

Conditions: Peripheral T-Cell Lymphoma

Treatments: Drug: Chidamide; Drug: Parsaclisib

Study type: Interventional

Funder types: Other

Identifiers

NCT05083208

HNSZLYYML06

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

PI3Kδ inhibitor Parsaclisib plus Chidamide

Experimental group

Description:

Parsaclisib is taken orally every day continuously, at approximately the same time every day, without food restriction, once a day. Chidamide is taken fixed 20mg twice a week with an interval of no less than 3 days, and taken 30 minutes after breakfast.

Treatment:

Drug: Parsaclisib

Drug: Chidamide