Linperlisib in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma

NCT05949944 | Recruiting Phase 1

• 1 other identifier: B2023-183
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This phase Ib/II, single arm, open label, multicenter study is conducted to evaluate the efficacy and safety of linperlisib in combination with CHOP for newly diagnosed PTCL patients, and explore the reasonable dosage of linperlisib when combined with CHOP regimen.

Conditions

Peripheral T-cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT, Phase Ib)

  To identify the DLT

  The first cycle of linperlisib in combination with R-CHOP regimen (21 days)

• Complete remission rate (CR rate) based on the 2014 Lugano evaluation criteria (Phase II)

  To investigate the antitumor efficacy

  Up to 18 weeks

Secondary Outcomes (6)

• Overall response rate (ORR)

  Up to 18 weeks

• Duration of complete remission

  From date of complete remission to the study treatment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

• Duration of remission (DOR)

  From date of remission to the study treatment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

• Progression free survival (PFS)

  From date of the first injection until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

• Overall survival (OS)

  From date of the first injection until the date of death from ant cause, assessed up to 24 months

Study Arms (1)

Linperlisib in combination with CHOP

EXPERIMENTAL

Patients will receive six cycles of induction therapy of linperlisib in combination with CHOP regimen. All patients with CR and PR after induction therapy receive linperlisib maintenance therapy every 28 days until disease progression or other reasons lead to discontinuation, and the duration of linperlisib maintenance does not exceed 24 months.

Drug: Linperlisib in combination with CHOP

Interventions

Linperlisib in combination with CHOP DRUG

Patients will receive six cycles of induction therapy of linperlisib in combination with CHOP regimen. All patients with CR and PR after induction therapy receive linperlisib maintenance therapy every 28 days until disease progression or other reasons lead to discontinuation, and the duration of linperlisib maintenance does not exceed 24 months.

Linperlisib in combination with CHOP

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed PTCL, including peripheral T-cell lymphoma non-specific type (PTCL NOS), angioimmunoblastic T-cell lymphoma (AITL), enteropathy related T-cell lymphoma and liver spleen T-cell lymphoma;
• Has not received anti-tumor treatment in the past;
• Age ≥18 years old, regardless of gender;
• Whole body physical condition score (ECOG) 0-2;
• Expected survival time\>3 months;
• Adequate bone marrow and organ functions;
• Not accompanied by hemophagocytic syndrome; If the patient is accompanied by clinically diagnosed hemophagocytic syndrome, after targeted anti hemophagocytic syndrome drug treatment, the researcher evaluates the patient's general physical condition to determine whether they can be enrolled.
• Volunteer to participate in clinical research and sign an informed consent form, willing to follow and capable of completing all trial procedures.

You may not qualify if:

• Received PI3K inhibitor treatment before enrollment;
• A history of other primary invasive malignant tumors that have not been relieved or have not been relieved for more than 3 years;
• Involvement of the central nervous system (meninges or brain parenchyma);
• Individuals who are known to have allergies to any medication in the study
• Participated in clinical trials of other drugs within 4 weeks prior to the start of the study;
• Pregnant or lactating women;
• Individuals with active infections, excluding fever related to tumor B symptoms;
• Concomitant diseases and medical history:
• There are many factors affecting oral medicine (such as inability to swallow, chronic diarrhea and Bowel obstruction);
• Individuals with a history of abuse of psychotropic substances who are unable to quit or have mental disorders;
• Subjects with any severe and/or uncontrollable diseases, including:
• Poor blood pressure control (systolic blood pressure ≥ 150mm Hg or diastolic blood pressure ≥ 100 mmHg);
• Suffering from ≥ Level 2 myocardial ischemia or infarction, arrhythmia (including QTc ≥ 450ms (male), QTc ≥ 470ms (female)), and ≥ Level 2 congestive heart failure (New York Heart Association (NYHA) classification);
• Active interstitial pneumonia or other chronic lung diseases, leading to severe impairment of lung function, defined as FEV1 and DLCOc\<60% of normal predicted values; A history of interstitial pneumonia caused by COVID-19.
• Liver abnormalities:

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

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

Central Study Contacts

Qingqing Cai, MD. PhD.

CONTACT

0086-20-87342823; caiqq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 18, 2023
• Study Start: August 15, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

CN (1)