Relapsed or Refractory Chronic Lymphocytic Leukemia MedDRA version: 21.0 Level: LLT Classification code 10008957 Term: Chronic lymphatic leukemia System Organ Class: 100000004864
Conditions
Interventions
Product Name: VENETOCLAX
Product Code: [ABT-199]
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: ABT-199
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numbe
Sponsors
OSPEDALE SAN RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Documented CLL requiring treatment according to the IWCLL criteria (Hallek et al. 2008) 2. Relapsed/refractory CLL patients who received at least 1 prior therapy 3. Adequate bone marrow function without transfusion =65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: 1. Transformation of CLL to aggressive NHL (Richter’s transformation or pro-lymphocytic leukemia) 2. Known central nervous system (CNS) involvement 3. Inadequate renal function: CrCl <30 mL/min 4. Previous treatment with BTK and/or BCL2 inhibitors (patients previously treated with PI3K inhibitors are eligible) 5. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia 6. 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 7. 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 8. 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. 9. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of the addition of ibrutinib to venetoclax in terms of minimal residual disease (MRD) negativity in patients with relapsed/refractory CLL;Secondary Objective: 1) To evaluate the safety of the addition of ibrutinib to venetoclax in patients with relapsed/refractory CLL 2) To evaluate the efficacy of the addition of ibrutinib to venetoclax in terms of overall response rate, partial and complete response rate, progression-free survival, duration of response and overall survival in patients with relapsed/refractory CLL ;Primary end point(s): ¿Minimal residual disease (MRD) negativity rate evaluated by multi-colour flow cytometry analysis (limit of detection 10-4) within the treatment period;Timepoint(s) of evaluation of this end point: during treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Complete response (CR) rate 2) Progression-free survival (PFS) rate at 12 months 3) PFS 4) Overall response rate (ORR) 5) Duration of response (DOR) 6) Overall Survival (OS); 7) Safety [type, frequency, and severity of adverse events (AEs) and relationship of AEs], premature withdrawals. ;Timepoint(s) of evaluation of this end point: during treatment period and follow up | — |
Countries
Italy
Contacts
Public Contactufficio data management
ospedale san raffaele
Outcome results
None listed