Clinical trial with Ibrutinib and Venetoclax for patients with Relapsed/Refractory Chronic Lymphocytic Leukemia

Phase 1

• Conditions: Relapsed or Refractory Chronic Lymphocytic Leukemia; Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]

• Registration Number: CTIS2024-514686-19-00
• Lead Sponsor: Ospedale San Raffaele S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-02
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Documented CLL requiring treatment according to the IWCLL criteria (Hallek et al. 2008), Relapsed/refractory CLL patients who received at least 1 prior therapy, Adequate bone marrow function without transfusion < 2 weeks of screening as follows: a. Absolute neutrophil count (ANC) =1.0 x 109/L (growth factors administration is allowed) b. Platelets =30 x 109/L. If thrombocytopenia due to BM involvement, platelets should be = 20 x 109/L c. Hemoglobin value =8.0 g/dl

Exclusion Criteria

Transformation of CLL to aggressive NHL (Richter’s transformation or pro-lymphocytic leukemia), Known central nervous system (CNS) involvement, Inadequate renal function: CrCl <30 mL/min, Previous treatment with BTK and/or BCL2 inhibitors (patients previously treated with PI3K inhibitors are eligible), Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia, Requires the use of warfarin, marcumar, or phenprocoumon (potential drug-drug interaction increasing exposure of warfarin or phenprocoumon): low molecular weight drugs e.g. heparin are acceptable, Treatment, administration or consumption of any of the following within 3 days prior to the first dose of venetoclax (see also Appendix G). a. Strong Cytochrome P450 3A (CYP3A) inhibitors b. Moderate CYP3A inhibitors c. Moderate or strong CYP3A inducers d. PI3K inhibitors (e.g. Idelalisib); e. Grapefruit or grapefruit products f. Seville oranges (including marmalade containing Seville oranges) g. Star fruit, Known history of human immunodeficiency virus (HIV) or active with hepatitis B virus (HBV) or hepatitis C virus (HCV). Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded., History of other malignancies, except: a. Malignancy treated with curative intent and with no known active disease present for =3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician. b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. c. Adequately treated carcinoma in situ without current evidence of disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified