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

NCT05083208 | Terminated Phase 1 DMC

• 1 other identifier: HNSZLYYML06
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Relapsed/Refractory Peripheral T-cell Lymphoma; PI3Kδ inhibitor; Chidamide

Outcome Measures

Primary Outcomes (2)

• Safety and Tolerability of Parsaclisib in Combination with Chidamide

  This outcome measure will evaluate the safety and tolerability of parsaclisib when administered in combination with chidamide. Safety will be assessed by monitoring adverse events (AEs), dose-limiting toxicities (DLTs), and other clinically significant toxicities according to the Common Terminology Criteria for Adverse Events (CTCAE). Tolerability will be assessed based on the occurrence and severity of AEs during the trial, as well as the ability of patients to complete the treatment regimen without discontinuation due to adverse effects.

  Approximately 2 years

• Recommended Phase 2 Dose (RP2D) of Parsaclisib in Combination with Chidamide

  This outcome measure will determine the recommended Phase 2 dose (RP2D) of parsaclisib when combined with a fixed dose of 20 mg of chidamide administered twice weekly (BIW). The RP2D will be determined based on dose escalation, safety data, and the tolerability observed in the Phase Ib portion of the study. The RP2D will be the highest dose level at which no more than 33% of patients experience dose-limiting toxicities (DLTs) within the first treatment cycle.

  Approximately 2 years

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  Through study completion, approximately 2 years

• Complete Response Rate (CRR)

  Through study completion, approximately 2 years

• 1-year progression-free survival

  from the day of the first cycle of treatment to the date of confirmed progressive disease or death, whichever occurs first, up to 2 years after last patient's enrollment (each cycle is 28 days).

• 1-year overall survival

  from date of the first cycle of treatment to the date of death from any cause, assessed up to 2 years after last patient's enrollment (each cycle is 28 days).

Other Outcomes (2)

• Correlation between baseline tumor gene mutation profile and clinical efficacy (CRR, PFS, OS)

  Through study completion, approximately 2 years

• Correlation between tumor microenvironment characteristics assessed by single-cell sequencing, flow cytometry and clinical efficacy (CRR, PFS, OS)

  Through study completion, approximately 2 years

Study Arms (1)

PI3Kδ inhibitor Parsaclisib plus Chidamide

EXPERIMENTAL

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.

Drug: Parsaclisib; Drug: Chidamide

Interventions

Parsaclisib 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.

Also known as: IBI376, PI3K inhibitor

PI3Kδ inhibitor Parsaclisib plus Chidamide

Chidamide 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.

PI3Kδ inhibitor Parsaclisib plus Chidamide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• Agreeing to follow the trail protocol requirements

You may not qualify if:

• 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
• 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
• Received PI3Kδ inhibitor treatment in the past
• Received autologous hematopoietic or allogeneic hematopoietic stem cell transplantation within 3 months
• World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) \>2
• There are factors that affect the absorption of oral drugs
• Pregnant or lactating women
• Researchers determine unsuited to participate in this trial

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

parsaclisib; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yanyan Liu, M.D. Ph.D

  Henan Cancer Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 18, 2021
• First Posted: October 19, 2021
• Study Start: February 20, 2022
• Primary Completion: June 30, 2024
• Study Completion: August 1, 2025
• Last Updated: December 2, 2025

Record last verified: 2024-05

Locations

CN (1)