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

NCT05976997 | Unknown Phase 2

• 1 other identifier: CSPC-KBT-PTCL-C01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Newly Diagnosed Peripheral T-cell Lymphoma

Keywords

Duvelisib; Chidamide; Peripheral T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Safety: Hematologic and non-hematologic toxicities (NCI CTCAE v5.0)

  To identify the incidence of AE and SAE in clinical trial

  from the initiation of the first dose to 28 days after the last dose

Secondary Outcomes (5)

• Objective response rate (ORR)

  up to 26 weeks

• Complete remission rate (CR)

  up to 26 weeks

• Duration of Response（DOR）

  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

• Progression free survival (PFS)

  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

• Overall survival (OS)

  From date of randomization until the date of death from any cause, assessed up to 20 months

Study Arms (1)

Duvelisib-Chidamide

EXPERIMENTAL

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.

Drug: Duvelisib, Chidamide

Interventions

Duvelisib, Chidamide DRUG

Duvelisib, 25mg, BID, PO; Chidamide, 20mg, BIW, PO;

Duvelisib-Chidamide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-70 Years (Contains boundary values 18 and 70);
• 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;
• ECOG ≤ 3;
• At least one measurable or evaluable tumor lesion according to the Lugano-2014 standard;
• Expected survival ≥ 3 months;
• Subjects fully understand and voluntarily participate in this study and sign informed consent;

You may not qualify if:

• Subjects who have previously received systemic treatment for lymphoma or currently undergoing anticancer treatment;
• Subjects with central nervous system (CNS) lymphoma or lymphoma involving CNS;
• 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;
• 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);
• Human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection and history of severe skin reaction;
• 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;
• Pregnant women, lactating women, patients who refused to take effective contraceptive measures during the study;
• Any serious uncontrolled systemic disease;
• increasing the risk of the subject or interfering with the test results determined by the investigator;

Sponsors & Collaborators

• Liling Zhang: lead
• CSPC Ouyi Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

duvelisib; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Liling Zhang, M.D

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liling Zhang, M.D

CONTACT

15871725926; 15871725926lily1228@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: August 4, 2023
• Study Start: May 8, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: August 4, 2023

Record last verified: 2023-07

Locations

CN (1)