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Prospective, Single Arm, Single Center Study of Duvelisib Combined With Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma (PTCL)

Primary Purpose

Newly Diagnosed Peripheral T-cell Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Duvelisib, Chidamide
Sponsored by
Liling Zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Newly Diagnosed Peripheral T-cell Lymphoma focused on measuring Duvelisib, Chidamide, Peripheral T-cell Lymphoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - 1.Age: 18-70 Years (Contains boundary values 18 and 70); 2.The newly diagnosed PTCL confirmed by histopathology is one of the following subtypes; a) Angioimmunoblastic T-cell lymphoma (AITL); b) Follicular T helper cell lymphoma (T-FHCL); Including but not limited to the above two subtypes; 3.ECOG ≤ 3; 4.At least one measurable or evaluable tumor lesion according to the Lugano-2014 standard; 5.Expected survival ≥ 3 months; 6.Subjects fully understand and voluntarily participate in this study and sign informed consent; Exclusion Criteria: - 1.Subjects who have previously received systemic treatment for lymphoma or currently undergoing anticancer treatment; 2.Subjects with central nervous system (CNS) lymphoma or lymphoma involving CNS; 3.Significant active heart disease within the past 6 months, including: New York Heart Association (NYHA) Class III/IV congestive heart failure unstable angina pectoris or angina requiring surgical or medication intervention, and/or myocardial infarction; 4.Uncontrolled systemic fungal, bacterial, or viral infections (defined as persistent signs/symptoms related to infection that have not improved despite the use of appropriate antibiotics, antiviral therapy, and/or other treatments); 5.Human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection and history of severe skin reaction; 6.Subjects with any other active malignant tumor at the time of screening, except for adequately treated cervical Carcinoma in situ or breast cancer Carcinoma in situ, skin Basal-cell carcinoma or local skin squamous cell carcinoma; 7.Pregnant women, lactating women, patients who refused to take effective contraceptive measures during the study; 8.Any serious uncontrolled systemic disease; 9.increasing the risk of the subject or interfering with the test results determined by the investigator;

Sites / Locations

  • Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Duvelisib-Chidamide

Arm Description

Patients with newly diagnosed PTCL were treated with a combination of Duvelisib and Chidamide. The dose of Duvelisib was 25mg twice a day. Every 4 weeks (28 days) is a cycle with a total of 2 cycles.

Outcomes

Primary Outcome Measures

Safety: Hematologic and non-hematologic toxicities (NCI CTCAE v5.0)
To identify the incidence of AE and SAE in clinical trial

Secondary Outcome Measures

Objective response rate (ORR)
To evaluate the efficacy of anti-lymphoma
Complete remission rate (CR)
To evaluate the efficacy of anti-lymphoma
Duration of Response(DOR)
To evaluate the efficacy of anti-lymphoma
Progression free survival (PFS)
To evaluate the efficacy of anti-lymphoma
Overall survival (OS)
To evaluate the efficacy of anti-lymphoma

Full Information

First Posted
July 16, 2023
Last Updated
July 27, 2023
Sponsor
Liling Zhang
Collaborators
CSPC Ouyi Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05976997
Brief Title
Prospective, Single Arm, Single Center Study of Duvelisib Combined With Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma (PTCL)
Official Title
Prospective, Single Arm, Single Center Study of Duvelisib Combined With Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma (PTCL)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Liling Zhang
Collaborators
CSPC Ouyi Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This is a prospective, single arm, single center study to evaluate the efficacy and safety of Duvelisib combined with Chidamide in the treatment of newly diagnosed peripheral T-cell lymphoma.
Detailed Description
This is a prospective, single arm, single center study, including two phases. It plans to recruit36 patients with clinically diagnosed primary PTCL who will be treated with Duvelisib and Chidamide. In the first phase Duvelisib is Oral administration at a dose of 25mg twice a day, and every 4 weeks (28 days) was a cycle. Next administration will be depend on whether the efficacy reaches CR in the second phase.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newly Diagnosed Peripheral T-cell Lymphoma
Keywords
Duvelisib, Chidamide, Peripheral T-cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Duvelisib-Chidamide
Arm Type
Experimental
Arm Description
Patients with newly diagnosed PTCL were treated with a combination of Duvelisib and Chidamide. The dose of Duvelisib was 25mg twice a day. Every 4 weeks (28 days) is a cycle with a total of 2 cycles.
Intervention Type
Drug
Intervention Name(s)
Duvelisib, Chidamide
Intervention Description
Duvelisib, 25mg, BID, PO; Chidamide, 20mg, BIW, PO;
Primary Outcome Measure Information:
Title
Safety: Hematologic and non-hematologic toxicities (NCI CTCAE v5.0)
Description
To identify the incidence of AE and SAE in clinical trial
Time Frame
from the initiation of the first dose to 28 days after the last dose
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
To evaluate the efficacy of anti-lymphoma
Time Frame
up to 26 weeks
Title
Complete remission rate (CR)
Description
To evaluate the efficacy of anti-lymphoma
Time Frame
up to 26 weeks
Title
Duration of Response(DOR)
Description
To evaluate the efficacy of anti-lymphoma
Time Frame
The time from the first assessment as CR or PR to the first assessment as PD or death (due to any cause),assessed up to 12 months
Title
Progression free survival (PFS)
Description
To evaluate the efficacy of anti-lymphoma
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months
Title
Overall survival (OS)
Description
To evaluate the efficacy of anti-lymphoma
Time Frame
From date of randomization until the date of death from any cause, assessed up to 20 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - 1.Age: 18-70 Years (Contains boundary values 18 and 70); 2.The newly diagnosed PTCL confirmed by histopathology is one of the following subtypes; a) Angioimmunoblastic T-cell lymphoma (AITL); b) Follicular T helper cell lymphoma (T-FHCL); Including but not limited to the above two subtypes; 3.ECOG ≤ 3; 4.At least one measurable or evaluable tumor lesion according to the Lugano-2014 standard; 5.Expected survival ≥ 3 months; 6.Subjects fully understand and voluntarily participate in this study and sign informed consent; Exclusion Criteria: - 1.Subjects who have previously received systemic treatment for lymphoma or currently undergoing anticancer treatment; 2.Subjects with central nervous system (CNS) lymphoma or lymphoma involving CNS; 3.Significant active heart disease within the past 6 months, including: New York Heart Association (NYHA) Class III/IV congestive heart failure unstable angina pectoris or angina requiring surgical or medication intervention, and/or myocardial infarction; 4.Uncontrolled systemic fungal, bacterial, or viral infections (defined as persistent signs/symptoms related to infection that have not improved despite the use of appropriate antibiotics, antiviral therapy, and/or other treatments); 5.Human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection and history of severe skin reaction; 6.Subjects with any other active malignant tumor at the time of screening, except for adequately treated cervical Carcinoma in situ or breast cancer Carcinoma in situ, skin Basal-cell carcinoma or local skin squamous cell carcinoma; 7.Pregnant women, lactating women, patients who refused to take effective contraceptive measures during the study; 8.Any serious uncontrolled systemic disease; 9.increasing the risk of the subject or interfering with the test results determined by the investigator;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liling Zhang, M.D
Phone
15871725926
Email
15871725926lily1228@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liling Zhang, M.D
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liling Zhang, M.D
Phone
15871725926
Email
15871725926lily1228@sina.com
First Name & Middle Initial & Last Name & Degree
Liling Zhang, M.D

12. IPD Sharing Statement

Learn more about this trial

Prospective, Single Arm, Single Center Study of Duvelisib Combined With Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma (PTCL)

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