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

Launched by RUIJIN HOSPITAL · Jun 20, 2023

Keywords

ClinConnect Summary

The CHANT study is looking into the use of Duvelisib, a medication in capsule form, for treating various types of non-Hodgkin's lymphoma (NHL), which is a type of cancer that affects the lymphatic system. This study will take place at multiple locations and aims to see how effective and safe Duvelisib is for patients who have already undergone at least one round of chemotherapy but are experiencing relapses or progression of their disease.

To be eligible for this study, participants need to be at least 18 years old and have a confirmed diagnosis of one of the NHL subtypes, such as follicular lymphoma or diffuse large B-cell lymphoma. They also need to have adequate organ function and a performance status that indicates they can carry out daily activities. Participants can expect to be involved in regular check-ups and monitoring throughout the study, but it's important to know that the trial is not yet recruiting participants at this time. If you're considering participation, you'll need to voluntarily agree and sign a consent form, and if you have certain health conditions or are pregnant or breastfeeding, you may not be able to join.

Gender

ALL

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.