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

Not yet recruiting

• Conditions: Marginal Zone Lymphoma; Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Peripheral T Cell Lymphoma; Diffuse Large B Cell Lymphoma; Richter Syndrome; Follicular Lymphoma
• Interventions: Drug: Duvelisib

• Registration Number: NCT05923502
• Lead Sponsor: Ruijin Hospital

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).

Study Timeline

• Study First Submitted: 2023-06-20
• Study First Submitted QC: 2023-06-20
• Study First Posted: 2023-06-28
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Study Start: 2023-10-20
• Last Update Posted: 2023-10-23
• Primary Completion: 2027-11-30
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All enrolled patients.	Duvelisib	All patient who signed the consent form for participation to the study.

Primary Outcome Measures

Name	Time	Method
Adverse events (AE)	From the first day of medication to 30 days after the last dose]	The safety of the drug was evaluated by NCI-CTC AE 5.0 standard.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	4 year	From the date of inclusion to date of death, irrespective of cause.
Overall Response Rate (ORR)	up to 6 cycles of therapy (each cycle is 28 days)]	Defined as the best response of complete response/remission (CR) or partial response/remission (PR).
Quality of life (QOL)	4 year	The quality of life scale, ranging from 0 to 100. A score of 0 represents the worst health and a score of 100 represents the best health.
Duration of remission (DOR)	4 year	Time from reaching CR or PR for the first time to disease progression.
Progression-Free-Survival (PFS)	4 year	From date of inclusion to date of progression, relapse, or death from any cause.