Clinical trial · Observational
(CHANT)Real World Study of Duvelisib in the Treatment of Non-Hodgkin's Lymphoma (NHL)
(CHANT)A Prospective, Multicenter, Non-interventionistic Real-world Study of Duvelisib Capsules in the Treatment of Non-Hodgkin's Lymphoma (NHL).
NCT05923502CI-TRIAL-00070677not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Marginal Zone Lymphoma | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Peripheral T Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
| Richter Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Duvelisib | Drug | Duvelisib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- All enrolled patients.
- description
- All patient who signed the consent form for participation to the study.
- interventionNames
- Drug: Duvelisib
Primary outcomes (1)
- measure
- Adverse events (AE)
- timeFrame
- From the first day of medication to 30 days after the last dose]
- description
- The safety of the drug was evaluated by NCI-CTC AE 5.0 standard.
Secondary outcomes (5)
- measure
- Overall Response Rate (ORR)
- timeFrame
- up to 6 cycles of therapy (each cycle is 28 days)]
- description
- Defined as the best response of complete response/remission (CR) or partial response/remission (PR).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.