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

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Препарат Duvelisib
  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.

Первичные конечные точки

• Adverse events (AE) [Срок оценки: From the first day of medication to 30 days after the last dose]]

Вторичные конечные точки (5)

• Overall Response Rate (ORR) [Срок оценки: up to 6 cycles of therapy (each cycle is 28 days)]]
• Duration of remission (DOR) [Срок оценки: 4 year]
• Progression-Free-Survival (PFS) [Срок оценки: 4 year]
• Overall survival (OS) [Срок оценки: 4 year]
• Quality of life (QOL) [Срок оценки: 4 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05923502 · CSPC-PI3K-NHL-K01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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