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

Follicular Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05923502
• Other study ID #: CSPC-PI3K-NHL-K01
• Status: Not yet recruiting
• Start date: October 20, 2023
• Est. completion date: November 30, 2027

Study information

• Verified date: October 2023
• Source: Ruijin Hospital
• Contact: Weili Zhao, PhD
• Phone: 021-64370045
• Email: zwl_trial[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 30, 2027
• Est. primary completion date: November 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
• Diffuse Large B Cell Lymphoma
• Follicular Lymphoma
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Non-Hodgkin
• Lymphoma, T-Cell, Peripheral
• Marginal Zone Lymphoma
• Peripheral T Cell Lymphoma
• Richter Syndrome

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events (AE)	The safety of the drug was evaluated by NCI-CTC AE 5.0 standard.	From the first day of medication to 30 days after the last dose]
Secondary	Overall Response Rate (ORR)	Defined as the best response of complete response/remission (CR) or partial response/remission (PR).	up to 6 cycles of therapy (each cycle is 28 days)]
Secondary	Duration of remission (DOR)	Time from reaching CR or PR for the first time to disease progression.	4 year
Secondary	Progression-Free-Survival (PFS)	From date of inclusion to date of progression, relapse, or death from any cause.	4 year
Secondary	Overall survival (OS)	From the date of inclusion to date of death, irrespective of cause.	4 year
Secondary	Quality of life (QOL)	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.	4 year