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

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

NCT ID: NCT05923502

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

Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, Large B-Cell, Diffuse

Conditions: Keywords:
NHL; Duvelisib

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Drug
Intervention name: Duvelisib
Description: 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.
Arm group label: All enrolled patients.

Other name: Copiktra

Summary: 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: 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).

Criteria for eligibility:

Study pop:
Population 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).

Sampling method: Non-Probability Sample
Criteria:
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: 1. Follicular lymphoma (FL); 2. Chronic lymphocytic leukemia/small lymphocytic lymphoma or Richter syndrome (CLL/SLL or RS); 3. Marginal zone lymphoma (MZL); 4. Peripheral T-cell lymphoma (PTCL); 5. 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: 1. 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; 2. Liver and kidney function: Aspartate transaminase (AST) and alanine aminotransferase (ALT)≤5.0 × ULN; 3. 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: October 20, 2023

Completion date: November 30, 2027

Lead sponsor:
Agency: Ruijin Hospital
Agency class: Other

Source: Ruijin Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05923502