RITUXIMAB for Diffuse large B-cell lymphoma

Inclusion criteria

• {"criterion_text":"- Able to provide written informed consent form approved by the National Ethics Committee (NEC) prior to the initiation of any screening or study-specific procedures and able to understand and to comply with the requirements of the study and the schedule of assessments.\n- Adequate renal function defined as creatinine clearance ≥ 30 mL/min (Appendix G). The same CrCl cutoff applies in case of documented renal involvement by lymphoma\n- Adequate hepatic function per local laboratory reference range, unless secondary to lymphoma, as follows: Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.0 x ULN; Bilirubin ≤ 2 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)\n- Subject must be able to adhere to the study visit schedule and other protocol requirements\n- Subject must be able to swallow capsules or tablets\n- Life expectancy ≥ 3 months\n- Male subjects must practice complete abstinence or agree to use specified contraceptive methods during sexual contact with a female of childbearing potential while participating in the study, for at least 28 days following investigational product discontinuation, even if he has undergone a successful vasectomy. Furthermore, they do not have to donate sperm during the study and for at least 28 days after receiving the last dose of study drug. If applicable, male subjects must receive study specific Pregnancy Prevention Plan (PPP).\n- Histologically documented diagnosis of DLBCL as defined in the 5th edition of the World Health Organization (WHO) classification (2022)\n- Previously untreated\n- Frail patients defined as follows (Appendix A-D): Age ≥ 80 years: activity of daily living (ADL) < 6 residual functions and/or Instrumental activity of daily living (IADL) < 8 residual functions and/or cumulative illness rating scale (CIRS) > 5 comorbidities of grade 2 and/or one or more comorbidities of grade 3-4\n- Patient not eligible to anthracycline-based chemotherapy\n- Ann Arbor Stage I – IV (Appendix E)\n- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 3 (Appendix F)\n- At least one site of measurable nodal disease at baseline [≥ 1.5 cm] in the longest transverse diameter as determined by CT scan\n- Adequate hematological counts defined as follows: WBC > 2.5 x 10^9/L with ANC > 1.0 x 10^9/L unless due to bone marrow involvement by lymphoma; Platelet count ≥ 75 x 10^9/L unless due to bone marrow involvement by lymphoma; Hemoglobin ≥ 10 g/dL unless anemia related to active lymphoma"}

Exclusion criteria

• {"criterion_text":"- Histological diagnosis different from DLBCL\n- Central nervous system (CNS) involvement with lymphoma\n- Significant history of cardiac, neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent\n- Any history of other active malignancies within 5 years prior to study entry, except for adequately treated in situ carcinoma of the cervix uterine, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, previous malignancy confined and surgically resected with curative intent\n- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: a. Uncontrolled and/or active systemic infection (viral, bacterial or fungal), including active ongoing infection from SARS-CoV-2; b. Chronic or acute hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV i.e. hepatitis B surface (HBs) antigen (Ag) negative, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative, may participate; patients with positive anti-HBc antibody from previous infection or inactive carriers are eligible only with HBV-DNA negative and with concomitant treatment with Lamivudine or Tenofovir; c. Patients with presence of HCV antibody are eligible only if PCR negative for HCV-RNA\n- Human immunodeficiency virus (HIV) seropositivity\n- Absence of caregivers in non-autonomous patients"}

Primary endpoints

• {"endpoint_text":"- Progression free survival (PFS)","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Overall response rate (partial response, PR + complete response, CR) after the 6th cycle","definition_or_measurement_approach":"Overall response rate defined as partial response (PR) + complete response (CR) assessed after the 6th cycle."}
• {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Rate of treatment discontinuation due to AE or treatment intolerance","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in QoL assessment from baseline at 6 months and 12 months by EORTC QLQ C-30 and FACT-Lym questionnaires","definition_or_measurement_approach":"Quality of life measured by EORTC QLQ C-30 and FACT-Lym questionnaires at 6 and 12 months."}

Italy

Earliest CTIS Part Ii Submission Date

08-01-2025

Latest Decision Or Authorization Date

23-12-2025

Processing Time Days

349

Number Of Sites

20

Number Of Participants

47

Primary sponsor

Full Name

Fondazione Italiana Linfomi Ets

Organisation Type

Patient organisation/association

Country Of Registered Address

Italy