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

Peripheral T-Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05083208
• Other study ID #: HNSZLYYML06
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 20, 2022
• Est. completion date: January 2027

Study information

• Verified date: May 2024
• Source: Henan Cancer Hospital
• Contact: Yanyan Liu, M.D. Ph.D
• Phone: +8613818176375
• Email: yyliu[@]zzu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: January 2027
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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, ?/d 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 PI3Kd 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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T-Cell Lymphoma

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
China	Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate	the total proportion of patients with complete response (CR) and partial response (PR)	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).
Secondary	2-year progression-free survival	the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first	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).
Secondary	2-year overall survival	from date of first day of treatment to the date of death by any cause	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).
Secondary	incidence and relationship with study drugs of grade 3-4 adverse events	the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v4.03	from the date of the first cycle of treatment to 2 years after last patient's enrollment (each cycle is 28 days).