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

October 18, 2023 updated by: Zhao Weili, Ruijin Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All enrolled patients.
All patient who signed the consent form for participation to the study.
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.
Other Names:
  • Copiktra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (AE)
Time Frame: 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.
From the first day of medication to 30 days after the last dose]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: 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).
up to 6 cycles of therapy (each cycle is 28 days)]
Duration of remission (DOR)
Time Frame: 4 year
Time from reaching CR or PR for the first time to disease progression.
4 year
Progression-Free-Survival (PFS)
Time Frame: 4 year
From date of inclusion to date of progression, relapse, or death from any cause.
4 year
Overall survival (OS)
Time Frame: 4 year
From the date of inclusion to date of death, irrespective of cause.
4 year
Quality of life (QOL)
Time Frame: 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.
4 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Investigators

  • Principal Investigator: Weili Zhao, PhD, Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 20, 2023

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

June 20, 2023

First Submitted That Met QC Criteria

June 20, 2023

First Posted (Actual)

June 28, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPC-PI3K-NHL-K01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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