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NCT Number: NCT05923502

(CHANT)Real World Study of Duvelisib 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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

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.

Treatment and study plan

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.

Other names: Copiktra

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. Duration of remission (DOR)

    Time frame: 4 year

    Time from reaching CR or PR for the first time to disease progression.

  3. Progression-Free-Survival (PFS)

    Time frame: 4 year

    From date of inclusion to date of progression, relapse, or death from any cause.

  4. Overall survival (OS)

    Time frame: 4 year

    From the date of inclusion to date of death, irrespective of cause.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Weili Zhao, PhD

CONTACT

[email protected]

021-64370045

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 28, 2023
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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