Actively Recruiting
Linperlisib Combination With Cyclophosphamide, Prednisone, and Thalidomide (CPT) in R/R NHL
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-09-29
180
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Linperlisib Combination With Cyclophosphamide, Prednisone, and Thalidomide (CPT) in R/R NHL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, 18 years old or older
- Histologically confirmed diagnosis of FL, PTCL, NKTCL, CLL, MZL, or MCL
- At least one measurable or evaluable lesion according to 2014 Lugano lymphoma criteria (except CLL)
- FL patients relapsed after second-line or more systemic therapy including CD20 monoclonal antibody and alkylating agents
- PTCL patients with prior systemic treatment and disease progression or no response; includes specified subtypes; ALCL patients must have received or be ineligible for CD30-targeted therapy
- NKTCL patients with prior systemic treatment including Pegaspargase or L-Pegaspargase and disease progression or no response
- CLL patients with measurable lesions and resistance or intolerance to prior therapies including BTK or BCL-2 inhibitors; treatment initiation as per IWCLL guidelines
- MZL patients with at least two prior systemic therapies including CD20 monoclonal antibodies and insufficient response or disease progression
- MCL patients with prior second-line or higher treatment including anti-CD20 immunotherapy and BTK/BCL-2 inhibitors
- ECOG performance status of 0 to 2
- Expected survival of at least 3 months
- Good organ function
- At least 28 days washout from previous antineoplastic therapy
- Fertile participants willing to use effective contraception during study and for six months after last dose
- Voluntary participation with signed informed consent and willingness to complete all study procedures
You will not qualify if you...
- Prior progression on PI3K inhibitors
- Any other anti-cancer therapy within 4 weeks before enrollment
- Uncontrolled third-space effusions like massive pleural effusion or ascites
- Central nervous system involvement (meninges or brain)
- Long-term corticosteroid use exceeding 30mg prednisone daily or equivalent
- Conditions affecting drug intake or absorption such as inability to swallow, chronic diarrhea, or intestinal obstruction
- History of allergies or hypersensitivity to study drugs
- History of significant cardiac disease including angina, arrhythmias, myocardial infarction, or heart failure
- Active infections requiring treatment
- Uncontrolled diabetes, pulmonary fibrosis, acute/interstitial lung disease, or liver failure
- Hepatitis B or C infection with active viral replication
- Immunodeficiency conditions including HIV or history of organ or stem cell transplant
- Autologous hematopoietic stem cell transplant within 90 days prior to study
- Inability to receive preventive treatment for pneumocystis, herpes simplex, or herpes zoster
- Major surgery within 2 weeks before starting treatment
- Unresolved adverse events from prior treatments greater than grade 1
- Active bleeding or clotting disorders
- Pregnancy, breastfeeding, or positive pregnancy test
- Presence of severe concomitant diseases
- Other malignancies within last 5 years except specific skin and cervical cancers
- Live attenuated vaccines within 30 days prior to first dose
- Grade 3b follicular lymphoma or follicular lymphoma transformed to diffuse large B-cell lymphoma
- T-cell lymphoma or NK/T-cell lymphoma with hemophagocytic syndrome
- Any other conditions judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
H
Huayuan ZHU, MD, phD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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