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

NCT05923502 | Not Yet Recruiting DMC FDA Drug

• 1 other identifier: CSPC-PI3K-NHL-K01
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

NHL; Duvelisib

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall Response Rate (ORR)

  up to 6 cycles of therapy (each cycle is 28 days)]

• Duration of remission (DOR)

  4 year

• Progression-Free-Survival (PFS)

  4 year

• Overall survival (OS)

  4 year

• Quality of life (QOL)

  4 year

Study Arms (1)

All enrolled patients.

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

Drug: Duvelisib

Interventions

Duvelisib 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.

Also known as: Copiktra

All enrolled patients.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Conditions

Lymphoma, Follicular; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, B-Cell, Marginal Zone; Lymphoma, T-Cell, Peripheral; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin

Interventions

duvelisib

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, B-Cell; Lymphoma, T-Cell

Study Officials

• Weili Zhao, PhD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weili Zhao, PhD

CONTACT

021-64370045; zwl_trial@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: June 28, 2023
• Study Start: October 20, 2023
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: October 23, 2023

Record last verified: 2023-10