Back to resultsPI3Kδ Inhibitor Parsaclisib Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma
Primary Purpose
Peripheral T-Cell Lymphoma
Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Parsaclisib
Chidamide
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral T-Cell Lymphoma focused on measuring Relapsed/Refractory Peripheral T-cell Lymphoma, PI3Kδ inhibitor, Chidamide
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PI3Kδ inhibitor Parsaclisib plus Chidamide
Arm Description
Phase Ib (Explored the appropriate dose of Parsaclisib in combination with 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. Phase II: Induced treatment: Received the initial dose of Parsaclisib determined in Phase Ib within the first 8 weeks. Maintain treatment: 2.5mg 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.
Outcomes
Primary Outcome Measures
objective response rate
the total proportion of patients with complete response (CR) and partial response (PR)
Secondary Outcome Measures
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
2-year overall survival
from date of first day of treatment to the date of death by any cause
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
Full Information
NCT ID
NCT05083208
First Posted
September 18, 2021
Last Updated
December 26, 2021
Sponsor
Henan Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05083208
Brief Title
PI3Kδ Inhibitor Parsaclisib Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma
Official Title
A Single Arm, Single-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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henan Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a prospective single-arm, single-center, phase Ib/II clinical trial of PI3Kδ inhibitor Parsaclisib combined with chidamide for the treatment of relapsed/refractory peripheral T-cell lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T-Cell Lymphoma
Keywords
Relapsed/Refractory Peripheral T-cell Lymphoma, PI3Kδ inhibitor, Chidamide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PI3Kδ inhibitor Parsaclisib plus Chidamide
Arm Type
Experimental
Arm Description
Phase Ib (Explored the appropriate dose of Parsaclisib in combination with 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.
Phase II:
Induced treatment: Received the initial dose of Parsaclisib determined in Phase Ib within the first 8 weeks.
Maintain treatment: 2.5mg 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.
Intervention Type
Drug
Intervention Name(s)
Parsaclisib
Other Intervention Name(s)
IBI376, PI3K inhibitor
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Chidamide
Intervention Description
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.
Primary Outcome Measure Information:
Title
objective response rate
Description
the total proportion of patients with complete response (CR) and partial response (PR)
Time Frame
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 Outcome Measure Information:
Title
2-year progression-free survival
Description
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
Time Frame
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).
Title
2-year overall survival
Description
from date of first day of treatment to the date of death by any cause
Time Frame
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).
Title
incidence and relationship with study drugs of grade 3-4 adverse events
Description
the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v4.03
Time Frame
from the date of the first cycle of treatment to 2 years after last patient's enrollment (each cycle is 28 days).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanyan Liu, M.D. Ph.D
Phone
+8613818176375
Email
yyliu@zzu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yanyan Liu, M.D. Ph.D
Phone
+8613838176375
Email
yyliu@zzu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanyan Liu, M.D. Ph.D
Organizational Affiliation
Henan Cancer Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
City
Zhengzhou
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanyan Liu, M.D. Ph.D
Phone
+8613838176375
Email
yyliu@zzu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yanyan Liu, M.D. Ph.D
Phone
+8613818176375
Email
yyliu@zzu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yanyan Liu, M.D. Ph.D
12. IPD Sharing Statement
Learn more about this trial
PI3Kδ Inhibitor Parsaclisib Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma
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