Linperlisib Combination With Cyclophosphamide, Prednisone, and Thalidomide (CPT) in R/R NHL

NCT07195799 | Recruiting Phase 2

• 1 other identifier: 2024-SR-219
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, open-label, non-randomized, multi-cohort study to evaluate the efficacy and safety of linperlisib combined with cyclophosphamide, prednisone, and thalidomide (CPT) regimen in the treatment of relapsed and/or refractory non-Hodgkin lymphoma.

Conditions

Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Best Objective Response Rate

  The rate of best overall response is the proportion of patients who achieve their best recorded response (complete or partial) to treatment at any time during the study.

  On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 10, Day 1 of Cycle 13, Day 1 of Cycle 16, Day 1 of Cycle 19, Day 1 of Cycle 22, and Day 1 of Cycle 25 (each cycle is 28 days)

Secondary Outcomes (7)

• Complete remission rate

  On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 10, Day 1 of Cycle 13, Day 1 of Cycle 16, Day 1 of Cycle 19, Day 1 of Cycle 22, and Day 1 of Cycle 25 (each cycle is 28 days)

• Disease control rate

  On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 10, Day 1 of Cycle 13, Day 1 of Cycle 16, Day 1 of Cycle 19, Day 1 of Cycle 22, and Day 1 of Cycle 25 (each cycle is 28 days)

• Duration of Response

  On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 10, Day 1 of Cycle 13, Day 1 of Cycle 16, Day 1 of Cycle 19, Day 1 of Cycle 22, and Day 1 of Cycle 25 (each cycle is 28 days)

• Time To Response

  On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 10, Day 1 of Cycle 13, Day 1 of Cycle 16, Day 1 of Cycle 19, Day 1 of Cycle 22, and Day 1 of Cycle 25 (each cycle is 28 days)

• Progression-free survival

  From the first dose of treatment until the date of progression or date of death from any cause, whichever came first.

Study Arms (6)

PTCL

EXPERIMENTAL

Drug: Linperlisib combined with CPT regimen

NK/TCL

EXPERIMENTAL

Drug: Linperlisib combined with CPT regimen

CLL

EXPERIMENTAL

Drug: Linperlisib combined with CPT regimen

MZL

EXPERIMENTAL

Drug: Linperlisib combined with CPT regimen

MCL

EXPERIMENTAL

Drug: Linperlisib combined with CPT regimen

FL

EXPERIMENTAL

Drug: Linperlisib combined with CPT regimen

Interventions

Linperlisib combined with CPT regimen DRUG

Linperlisib: 80mg QD during the cycle 1-2，80mg QD for the first 7 days of cycle 3-6 (each cycle is 28 days) Cyclophosphamide: 50mg QD during the cycle 1-6 (each cycle is 28 days) Prednisone: 20mg QD during the cycle 1-6 (each cycle is 28 days) Thalidomide: 50mg QD during the cycle 1-6 (each cycle is 28 days) After six cycles, patients with CR or PR continue to receive linperlisib at a dose of 80mg for the first 7 days every cycle (each cycle is 28 days) until disease progression, intolerable toxicity, investigator judgment that treatment should be discontinued, or subject withdrawal of consent, whichever occurred first.

CLL

Eligibility Criteria

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

You may qualify if:

• Male or female, ≥18 years old;
• Histologically confirmed diagnosis of FL/PTCL/NKTCL/CLL /MZL/MCL;
• Except for CLL (using the 2018 iwCLL criteria), patients must have at least one measurable lesion/evaluable lesion that meets the 2014 version of Lugano lymphoma evaluation criteria;
• FL patients:
• Should be relapsed after second-line or more systemic therapy (CD20 monoclonal antibody and at least one alkylating agent, including but not limited to bendamustine, fludarabine, cyclophosphamide, isocyclophosphamide, etc.); 5. PTCL patients:
• Have previously received at least one-line systemic treatment, have disease progression during or after the most recent treatment, or confirmed no objective response with adequate treatment;
• Includes the following subtypes: PTCL-NOS, AITL, ALK+ALCL, ALK-ALCL，EATL; patients with ALCL must have previously received CD30-targeted therapy or be ineligible for CD30-targeted therapy; 6. NK/TCL patients:
• \) Have previously received at least one line systemic treatment, have disease progression during or after the most recent treatment, or have confirmed no objective response with adequate treatment; 2) Have previously received a regimen containing Pegaspargase or L-Pegaspargase; 7. CLL patients:
• Have measurable lesions (peripheral blood B lymphocytes ≥5×10\^9/L, or enlarged lymph node (baseline LDi ≥ 1.5cm), or hepatomegaly or splenomegaly due to CLL);
• Patients with resistance or intolerance following prior first-line or above therapy (regiments containing BTK inhibitors or BCL-2 inhibitors);
• Treatment should be initiated when at least one indication for treatment according to IWCLL guideline are present; 8. MZL patients: Should have previously received at least two-line systemic therapy containing CD20 monoclonal antibodies and have not achieved at least partial response (PR) after recent systemic therapy, or have confirmed disease progression after treatment, and investigators judge that effective and standard treatment options are lacking; 9. MCL patients:
• Previous second-line or higher treatment regimen including:
• at least first-line immunotherapy or chemical immunotherapy containing anti-CD20 monoclonal antibody; Or anti-CD20 mab combined with BTK inhibitors;
• have been treated with at least one appropriate BTK inhibitor and BCL-2 inhibitor (monotherapy or in combination with other antineoplastic agents); 10. ECOG PS: 0\~2; 11. Expected survival ≥ 3 months; 12. Good organ function; 13. The washout period from the end of any previous antineoplastic therapy, including radiation therapy, chemotherapy, hormone therapy, surgery, or molecular-targeted therapy until participate in the trial should be at least 28 days or five half-life of the drug, whichever was shorter; 14. Fertile male and female subjects are willing to use effective contraceptive measures throughout the study period and for six months after the last dose; 15. Volunteer to participate in clinical studies and sign informed consent, willing to follow and able to complete all trial procedures.

You may not qualify if:

• Patients with any of the following conditions are not eligible to participate in this study:
• Had been progressed on PI3K inhibitor before enrollment;
• Any other anti-tumor therapy within 4 weeks;
• The presence of third-space effusion (e.g., massive pleural effusion and ascites) that could not be controlled by drainage or other methods;
• Involvement of the central nervous system (meninges or brain parenchyma);
• Long-term use of corticosteroids exceeding 30mg/day of prednisone or its equivalent;
• Inability to swallow, chronic diarrhea or intestinal obstruction, or other factors affecting drug intake and absorption;
• Individuals with a history of allergies or known hypersensitivity to any component of the regimen;
• A history of any cardiac disease, including: (1) angina; (2) arrhythmias requiring clinical intervention; (3) myocardial infarction; (4) heart failure; (5) any other cardiac conditions deemed unsuitable for participation in this trial by the investigator;
• Active viral, bacterial, or fungal infections requiring treatment (such as pneumonia);
• Uncontrolled diabetes, pulmonary fibrosis, acute lung disease, interstitial lung disease, or liver failure;
• Individuals with HBV or HCV infection (defined as positive for HbsAg and/or HbcAb with detectable HBV DNA copies) or positive for active hepatitis C (HCV) antibodies;
• A history of immunodeficiency, including positive HIV testing, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation, or a history of allogeneic bone marrow or hematopoietic stem cell transplantation;
• Received autologous hematopoietic stem cell transplantation within 90 days prior to the first dose of study treatment;
• Could not receive preventive treatment for pneumocystis, HSV, or HZV at screening;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Huayuan ZHU, MD, phD

CONTACT

+86-13813810650; huayuan.zhu@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: September 29, 2025
• Study Start: December 31, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 29, 2025

Record last verified: 2024-12

Locations

CN (1)