NCT05923502Not yet recruiting
(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).
Source: ClinicalTrials.gov · Last updated 23 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 20 Jun 2023
- Start date
- 20 Oct 2023
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- Ruijin Hospital
- NCT number
- NCT05923502
What you commit to
- Study type: Observational
- Planned participants: 200
- From 20 Oct 2023 to the primary completion date, 30 Nov 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- 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.
Other illness
- Known hypersensitivity to Duvelisib or its excipients;
Other
- Female subjects who are pregnant or breastfeeding;
- Estimated lifetime is less than 3 months;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.