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

Shanghai Jiao Tong University

Status

Not yet enrolling

Conditions

Marginal Zone Lymphoma

Follicular Lymphoma

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Richter Syndrome

Diffuse Large B Cell Lymphoma

Peripheral T Cell Lymphoma

Treatments

Drug: Duvelisib

Study type

Observational

Funder types

Other

Identifiers

NCT05923502

CSPC-PI3K-NHL-K01

Details and patient eligibility

About

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.

Full 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).

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.