Previously Untreated Chronic Lymphophatic Leukaemia MedDRA version: 21.0 Level: LLT Classification code 10009310 Term: CLL System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Venclyxto
Product Name: venclyxto
Product Code: [venclyxto]
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: venetoclax
CAS Number: 1257044-40-8
Current Sponsor code: vene
Sponsors
OSPEDALE SAN RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 but =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous treatment for CLL/SLL 2. History of other malignant malignancies, except in situ carcinoma or malignant cancers treated with curative intent 3. Known story or suspected transformation of Richter 4. Hypersensitivity known to one or more drugs in the study 5. Inadequate kidney function: CrCl <30 ml/min 6. Autoimmune hemolytic anemia or uncontrolled autoimmune platelets 7. Need for warfarin or derivatives therapy 8. Treatment within 7 days before the first dose of the drug in the study with one of the following: a. Steroid therapy with antineoplastic intent B. Moderate or powerful cytochrome inhibitors P450 3A (CYP3A) (see Appendix G for examples) C. Moderate or strong CYP3A inducers (see Appendix G for examples) 9. Administration or consumption of any of the following within 3 days before the first dose of the drug in the study: a. Pompelmo or grapefruit products B. Seville oranges (including jam containing Seville oranges) c. Carambola 10. Known history of human immunodeficiency virus (HIV) or active infection with hepatitis B virus (HBV) or hepatitis C (HCV). Subjects who are positive for HBcAb, HBsAb or the hepatitis C antibody should have a negative result of the polymerase chain reaction (PCR) prior to enlistment. Those who test positive for PCR will be excluded. 11. Note hypersensitivity to one or more drugs in the study 12. Known hemorrhagic disorders (e.g. von Willebrand's disease) or haemophilia 13. History of stroke or intracranial bleeding in the 6 months prior to enlistment 14. Major surgery within 4 weeks of first dose of the drug in the study 15. Cardiovascular disease currently active and clinically significant such as uncontrolled arrhythmia or congestive heart failure of class 3 or 4 as defined by the functional classification of the New York Heart Association or a history of myocardial infarction, unstable angina
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the effectiveness of the sequential combination of venetoclax, delayed rituximab and ibrutinib in terms of minimal remaining undetectable disease (uMRD, <10-4) detected with 6-color cytofluorimetry in BM as the best response at any time during treatment up to 3 months after the completion of combined therapy;Secondary Objective: Evaluate the effectiveness of the sequential combination of venetoclax, delayed rituximab and ibrutinib in terms of: - uMRD detected with 6-color cytofluorytry in PB as the best response at any time during treatment up to 3 months after the completion of combined therapy - Overall response (best response) - Full answer, CR (best answer) - Partial response, PR (best answer) - Progression-free survival - Global Survival;Primary end point(s): uMRD (<10-4) evaluated by 6-color cytofluorymetry in BM as the best response at any time during treatment up to 3 months after supplementation of combination therapy (VR or VR followed by VI);Timepoint(s) of evaluation of this end point: 72 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 72 months;Secondary end point(s): uMRD (<10-4) evaluated by 6-color cytofluorymetry in PB as the best response at any time during treatment up to 3 months after supplementation of combination therapy (VR or VR followed by VI) | — |
Countries
Italy
Contacts
Public ContactProgramma di Ricerca Strategica sul
Ospedale San Raffaele
Outcome results
None listed