Obinutuzumab for Chronic lymphocytic leukemia | Small lymphocytic lymphoma

Inclusion criteria

• {"criterion_text":"- Age >=18 years\n- Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocyte lymphoma (SLL) according to iwCLL diagnostic criteria\n- Previously untreated active disease requiring treatment according to iwCLL criteria\n- ECOG PS 0 or 1\n- Lymph node disease measurable (longest diameter> 1.5 cm) by CT\n- Adequate blood count defined as: Absolute neutrophil count (ANC)> 750 cells / μL (750 cells / mm3 or 0.75 x 109 / L), Platelet count> 30,000 / μL (30,000 cells / mm3 or 30 x 109 / L), Hemoglobin> 8.0 g / dL\n- Adequate liver and kidney function defined as: Serum aspartate transaminase (AST) or alanine transaminase (ALT) =3.0 x upper limit of normal (ULN) , Estimated Creatinine Clearance (CrCl) =30 mL / min (Cockcroft-Gault), Bilirubin =1.5 x ULN (unless increased bilirubin is due to Gilbert's syndrome or of non-hepatic origin)\n- Prothrombin time (PT) / International normal ratio (INR) <1.5 x ULN and PTT (activated partial thromboplastin time [aPTT]) <1.5 x ULN (unless abnormalities are related to coagulopathy or bleeding disorder)"}

Exclusion criteria

• {"criterion_text":"- Any prior therapy (including but not limited to chemotherapy, targeted therapy, immunomodulatory therapy, radiotherapy, and / or monoclonal antibody) used to treat CLL or SLL.\n- Concomitant use of warfarin or other vitamin K antagonists.\n- Major surgery within 4 weeks of the first dose of study drug\n- Patients with del (17p) and / or TP53 mutation according to centralized laboratory assessment.\n- History of other malignancies, except: Malignant tumor treated with curative intent and with no known active disease present for =3 prior to first dose of study drug and deemed low risk of recurrence by treating physician, Malignant skin neoplasm not adequately treated or lentigo maligna with no evidence of disease, Adequately treated carcinoma in situ with no evidence of disease.\n- Known or suspected history of Richter's transformation.\n- Known hypersensitivity to one or more study drugs.\n- Known bleeding disorders (eg von Willebrand disease or haemophilia).\n- History of stroke or intracranial haemorrhage within 6 months prior to enrollment.\n- Known history of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV) or hepatitis B virus (HBV) infection. Individuals who are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who test positive for PCR will be excluded.\n- Inability to swallow capsules / tablets or malabsorption syndrome, any disease that significantly affects gastrointestinal function, or resection of the stomach or small intestine, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction."}

Primary endpoints

• {"endpoint_text":"- Percentage of patients with MRD <10-4 in BM at +30 follow-up days after completion of therapy","definition_or_measurement_approach":"Evaluate the percentage of BM MRD <10-4 in BM at +30 days of follow-up after ibrutinib (Cycles 1-24) and obinutuzumab (Cycle 13 Days 1,2,8,15; Cycles 14-18 Day 1) (measurement: MRD in bone marrow at +30 days after completion of therapy)."}

Italy

Earliest CTIS Part Ii Submission Date

10-07-2024

Latest Decision Or Authorization Date

05-08-2024

Processing Time Days

26

Number Of Sites

6

Number Of Participants

53

Primary sponsor

Full Name

Ospedale San Raffaele S.r.l.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy