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

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

Interventions

DRUG

Linperlisib combined with CPT regimen

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.

DRUG

Linperlisib combined with CPT regimen

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.

DRUG

Linperlisib combined with CPT regimen

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.

DRUG

Linperlisib combined with CPT regimen

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.

DRUG

Linperlisib combined with CPT regimen

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.

DRUG

Linperlisib combined with CPT regimen

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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-31

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• China

Study Locations