(CHANT)Real World Study of Duvelisib in the Treatment of Non-Hodgkin's Lymphoma (NHL)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Duvelisib.
- Who it may be relevant to
- Registry conditions: Follicular Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Richter Syndrome, Marginal Zone Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
(CHANT)A Prospective, Multicenter, Non-interventionistic Real-world Study of Duvelisib Capsules in the Treatment of Non-Hodgkin's Lymphoma (NHL).
Overview
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).
Interventions
- Drug 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.
Primary outcome measures
- Adverse events (AE) [Time frame: From the first day of medication to 30 days after the last dose]]
Secondary outcome measures (5)
- Overall Response Rate (ORR) [Time frame: up to 6 cycles of therapy (each cycle is 28 days)]]
- Duration of remission (DOR) [Time frame: 4 year]
- Progression-Free-Survival (PFS) [Time frame: 4 year]
- Overall survival (OS) [Time frame: 4 year]
- Quality of life (QOL) [Time frame: 4 year]
Eligibility 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:
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05923502 · CSPC-PI3K-NHL-K01