Clinical trial NCT05083208: PI3Kδ Inhibitor Parsaclisib Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Peripheral T-Cell Lymphoma
Keywords: Relapsed/Refractory Peripheral T-cell Lymphoma
PI3Kδ inhibitor
Chidamide
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2021-10-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: objective response rate
timeFrame: 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 outcomes:
measure: 2-year progression-free survival
timeFrame: 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).
measure: 2-year overall survival
timeFrame: 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).
measure: incidence and relationship with study drugs of grade 3-4 adverse events
timeFrame: from the date of the first cycle of treatment to 2 years after last patient's enrollment (each cycle is 28 days).
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Yanyan Liu, M.D. Ph.D
role: STUDY_DIRECTOR
References: