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Trial Title:
Prospective, Single Arm, Single Center Study of Duvelisib Combined With Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma (PTCL)
NCT ID:
NCT05976997
Condition:
Newly Diagnosed Peripheral T-cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Conditions: Keywords:
Duvelisib
Chidamide
Peripheral T-cell Lymphoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Duvelisib, Chidamide
Description:
Duvelisib, 25mg, BID, PO; Chidamide, 20mg, BIW, PO;
Arm group label:
Duvelisib-Chidamide
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.
Criteria for 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Contact:
Last name:
Liling Zhang, M.D
Phone:
15871725926
Email:
15871725926lily1228@sina.com
Investigator:
Last name:
Liling Zhang, M.D
Email:
Principal Investigator
Start date:
May 8, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
Liling Zhang
Agency class:
Other
Collaborator:
Agency:
CSPC Ouyi Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Huazhong University of Science and Technology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05976997
