Clinical trial NCT05923502: (CHANT)Real World Study of Duvelisib in the Treatment of Non-Hodgkin's Lymphoma (NHL)
Official title: (CHANT)A Prospective, Multicenter, Non-interventionistic Real-world Study of Duvelisib Capsules in the Treatment of Non-Hodgkin's Lymphoma (NHL).
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse events (AE)
timeFrame: From the first day of medication to 30 days after the last dose]
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: up to 6 cycles of therapy (each cycle is 28 days)]
measure: Duration of remission (DOR)
timeFrame: 4 year
measure: Progression-Free-Survival (PFS)
timeFrame: 4 year
measure: Overall survival (OS)
timeFrame: 4 year
measure: Quality of life (QOL)
timeFrame: 4 year
Other outcomes:
Locations:
Study officials:
affiliation: Ruijin Hospital
name: Weili Zhao, PhD
role: PRINCIPAL_INVESTIGATOR
References: