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New treatment option for Non-Hodgkin Lymphoma
Official title Linperlisib Combination With Cyclophosphamide, Prednisone, and Thalidomide (CPT) in R/R NHL
ClinicalTrials.gov ID: NCT07195799
What this study is testing
What is Linperlisib combined with CPT regimen?
Linperlisib combined with CPT regimen is an investigational medicine, being studied as a potential treatment for non-hodgkin lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- FL patients: Should be relapsed after second-line or more systemic therapy (CD20 monoclonal antibody and at least one alkylating agent, including but...
- Have previously received at least one-line systemic treatment, have disease progression during or after the most recent treatment, or confirmed no...
You likely can't join 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;
See the full eligibility criteria
Who can join
- 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...
- 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: 1) Have...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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;
- Major surgery within 2 weeks before starting treatment;
- Any adverse event related to prior treatment, but has not recovered to grade ≤ 1;
- Existing active bleeding or new thrombotic disease, or have a history of bleeding tendency;
- Pregnant or breastfeeding female patients, or women of childbearing potential with a positive baseline pregnancy test;
- Concomitant diseases (such as severe hypertension, diabetes, thyroid disease, etc.);
- Other malignancies within the last 5 years, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
- Received live attenuated vaccines within 30 days prior to the first dose;
- Histologically or cytologically confirmed patients with grade 3b follicular lymphoma, and known follicular lymphoma transformed into diffuse large B-cell lymphoma;
- T-cell lymphoma and NK/T-cell lymphoma with hemophagocytic syndrome;
- Other situations deemed unsuitable for inclusion in the study by the researcher.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.