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

NCT ID: NCT05083208

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-20
• Study Completion Date: 2025-08-01

Brief 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.

Conditions

Peripheral T-Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PI3Kδ inhibitor Parsaclisib plus Chidamide

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.

Group Type: EXPERIMENTAL

Parsaclisib

Intervention Type: DRUG

Phase Ib: Parsaclisib is taken orally every day continuously, at approximately the same time every day, without food restriction, once a day. This stage follows the traditional "3+3" model. Parsaclisib is set at 10 mg/day, 15 mg/day, 20 mg/day 3 dose groups, starting from 10 mg/day, each group included 3 subjects. The final dose determined at this stage will be used in the Phase II study. Patients without progression or unacceptable toxicity after 8 weeks enter maintenance treatment.

Maintain treatment: 2.5mg orally every day continuously, at approximately the same time every day, without food restriction, once a day until disease progression, death or unacceptable toxicity developments.

Chidamide

Intervention Type: DRUG

Phase Ib: Chidamide is taken fixed 20mg twice a week with an interval of no less than 3 days, and taken 30 minutes after breakfast, until progression or intolerance.

Interventions

Parsaclisib

Phase Ib: Parsaclisib is taken orally every day continuously, at approximately the same time every day, without food restriction, once a day. This stage follows the traditional "3+3" model. Parsaclisib is set at 10 mg/day, 15 mg/day, 20 mg/day 3 dose groups, starting from 10 mg/day, each group included 3 subjects. The final dose determined at this stage will be used in the Phase II study. Patients without progression or unacceptable toxicity after 8 weeks enter maintenance treatment.

Maintain treatment: 2.5mg orally every day continuously, at approximately the same time every day, without food restriction, once a day until disease progression, death or unacceptable toxicity developments.

Intervention Type: DRUG

Chidamide

Phase Ib: Chidamide is taken fixed 20mg twice a week with an interval of no less than 3 days, and taken 30 minutes after breakfast, until progression or intolerance.

Intervention Type: DRUG

Other Intervention Names

IBI376; PI3K inhibitor

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yanyan Liu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanyan Liu, M.D. Ph.D

Role: STUDY_DIRECTOR

Henan Cancer Hospital

Locations

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, China

Countries

China

Other Identifiers

HNSZLYYML06

Identifier Type: -

Identifier Source: org_study_id