(CHANT)Real World Study of Duvelisib in the Treatment of Non-Hodgkin's Lymphoma (NHL)

Study Overview
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Brief Summary
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This is a multicenter, non-interventional and prospective real-world study to evaluate the efficacy and safety of Duvelisib capsules in patients with non-Hodgkin's lymphoma.

Detailed Description
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This is a multicenter, non-interventional and prospective real-world study to evaluate the efficacy and safety of Duvelisib administered to subjects who have been diagnosed with non-Hodgkin's lymphoma that is relapsed or refractory, including but not limited to the following subtypes : a) Follicular lymphoma(FL); b) Chronic lymphocytic leukemia/small lymphocytic lymphoma or Richter syndrome(CLL/SLL or RS); c) Marginal zone lymphoma(MZL); d) Peripheral T-cell lymphoma(PTCL); e) Diffuse large B-cell lymphoma(DLBCL).

Official Title
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(CHANT)A Prospective, Multicenter, Non-interventionistic Real-world Study of Duvelisib Capsules in the Treatment of Non-Hodgkin's Lymphoma (NHL).

Conditions
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Follicular Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Richter Syndrome, Marginal Zone Lymphoma, Peripheral T Cell Lymphoma, Diffuse Large B Cell Lymphoma

Intervention / Treatment
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* Drug: Duvelisib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To participate in the study voluntarily and sign the informed consent (ICF), with good compliance and cooperative visits; Patients must be ≥ 18 years of age (Based on the date of signing the informed Consent (ICF)); Pathologically or Histologically confirmed NHL including but not limited to the following subtypes: Follicular lymphoma (FL); Chronic lymphocytic leukemia/small lymphocytic lymphoma or Richter syndrome (CLL/SLL or RS); Marginal zone lymphoma (MZL); Peripheral T-cell lymphoma (PTCL); Diffuse large B-cell lymphoma (DLBCL). Patients who have received at least one systemic chemotherapy and have relapsed at the end of the treatment or progressed during treatment; Must have adequate organ function defined by the following laboratory parameters: Bone marrow function: Absolute neutrophil count (ANC) ≥ 0.5 × 10^9/L, Platelet count (PLT) ≥ 25 × 10^9/L, blood transfusion can be used before medication; Liver and kidney function: Aspartate transaminase (AST) and alanine aminotransferase (ALT)≤5.0 × ULN; Estimated creatinine clearance value ≥30 milliliters/minute (as determined by the Cockcroft-Gault method). Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; Patients with infections should be treated first and then considered for enrollment when the infection is under control. Exclusion Criteria: Female subjects who are pregnant or breastfeeding; Estimated lifetime is less than 3 months; In the investigator's judgment, patients who require but are unable to receive prophylactic treatment for Pneumocystis or herpes simplex virus (HSV) prior to trial drug treatment; History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function; Prior history of drug-induced colitis or drug-induced interstitial pneumonia; Known hypersensitivity to Duvelisib or its excipients; Administration of medications or foods that are strong inhibitors or inducers of CYP3A beginning 2 weeks prior to the first dose of Duvelisib; According to the judgement of the researcher, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All enrolled patients.<br>All patient who signed the consent form for participation to the study. | Drug: Duvelisib<br>* This is a real-word. The treatment options are individualized according to the diagnosis and treatment experience of doctors in each center, diagnosis and treatment specifications and individual conditions of patients.<br>* Other names: Copiktra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AE) | The safety of the drug was evaluated by NCI-CTC AE 5.0 standard. | From the first day of medication to 30 days after the last dose] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | Defined as the best response of complete response/remission (CR) or partial response/remission (PR). | up to 6 cycles of therapy (each cycle is 28 days)] | 
| Duration of remission (DOR) | Time from reaching CR or PR for the first time to disease progression. | 4 year | 
| Progression-Free-Survival (PFS) | From date of inclusion to date of progression, relapse, or death from any cause. | 4 year | 
| Overall survival (OS) | From the date of inclusion to date of death, irrespective of cause. | 4 year | 
| Quality of life (QOL) | The quality of life scale, ranging from 0 to 100. A score of 0 represents the worst health and a score of 100 represents the best health. | 4 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NHL; Duvelisib