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Linperlisib Combination With Cyclophosphamide, Prednisone, and Thalidomide (CPT) in R/R NHL | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

A Multicenter Prospective Study of Linperlisib Combination With Cyclophosphamide, Prednisone, and Thalidomide (CPT) in Relapsed and/or Refractory Non-Hodgkin Lymphoma

NCT07195799•The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female, ≥18 years old;
•2. Histologically confirmed diagnosis of FL/PTCL/NKTCL/CLL /MZL/MCL;
•3. 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;
•4. 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:
•1. 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;
•2. 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:
•1\) 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:
•1. 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);
•2. Patients with resistance or intolerance following prior first-line or above therapy (regiments containing BTK inhibitors or BCL-2 inhibitors);
+4 more criteria

Exclusion Criteria

•1. Had been progressed on PI3K inhibitor before enrollment;
•2. Any other anti-tumor therapy within 4 weeks;
•3. The presence of third-space effusion (e.g., massive pleural effusion and ascites) that could not be controlled by drainage or other methods;
•4. Involvement of the central nervous system (meninges or brain parenchyma);
•5. Long-term use of corticosteroids exceeding 30mg/day of prednisone or its equivalent;
•6. Inability to swallow, chronic diarrhea or intestinal obstruction, or other factors affecting drug intake and absorption;
•7. Individuals with a history of allergies or known hypersensitivity to any component of the regimen;
•8. 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;
•9. Active viral, bacterial, or fungal infections requiring treatment (such as pneumonia);
•10. Uncontrolled diabetes, pulmonary fibrosis, acute lung disease, interstitial lung disease, or liver failure;
+14 more criteria

Locations (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Key Dates

Start Date

December 31, 2024

Primary Completion Date

December 31, 2027

Completion Date

December 31, 2027

Last Updated

September 29, 2025

Enrollment

180

ESTIMATED participants

Conditions

Non-Hodgkin Lymphoma

Interventions