Clinical trial

A Single Arm, Multi-center, Phase Ib/II Clinical Trial of PI3Kδ Inhibitor Parsaclisib Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma

Name

HNSZLYYML06

Description

This is a prospective single-arm, multicenter, phase Ib/II clinical trial of PI3Kδ inhibitor Parsaclisib combined with chidamide for the treatment of relapsed/refractory peripheral T-cell lymphoma.

Trial arms

Trial start

2022-02-20

Estimated PCD

2024-06-30

Trial end

2027-01-01

Status

Recruiting

Phase

Early phase I

Treatment

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. Phase II: Induced treatment: Received the initial dose of Parsaclisib determined in Phase Ib within the first 8 weeks (including the treatment received in Phase Ib). 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. The maximum treatment time of Parsaclisib is no more than 2 years.

Arms:

PI3Kδ inhibitor Parsaclisib plus Chidamide

Other names:

IBI376, PI3K inhibitor

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. Phase II: Chidamide is taken fixed 20mg twice a week with an interval of no less than 3 days, and taken 30 minutes after breakfast until disease progression, death or unacceptable toxicity developments.

Arms:

PI3Kδ inhibitor Parsaclisib plus Chidamide

Size

Primary endpoint

objective response rate

every 8 or 12 weeks from the day of the first cycle to 2 years after the last patient's enrollment (each cycle is 28 days).

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 28, 'type': 'ESTIMATED'}}

Updated at

2024-05-07

1 organization

Organization

Henan Cancer Hospital