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

NCT ID: NCT05923502

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-20
• Study Completion Date: 2027-11-30

Brief 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).

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

All enrolled patients.

All patient who signed the consent form for participation to the study.

Duvelisib

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Copiktra

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:

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Weili

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weili Zhao, PhD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Central Contacts

Weili Zhao, PhD

Role: CONTACT

zwl_trial@163.com

021-64370045

Other Identifiers

CSPC-PI3K-NHL-K01

Identifier Type: -

Identifier Source: org_study_id