Resumen

This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The time on study treatment was approximately one year and the follow-up period will be up to 9 years

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Documented previously untreated CLL according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria
CLL requiring treatment according to IWCLL criteria
Total Cumulative Illness Rating Scale (CIRS score) greater than (\>) 6
Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening as per protocol, unless cytopenia is due to marrow involvement of CLL
Adequate liver function
Life expectancy \> 6 months
Agreement to use highly effective contraceptive methods per protocol

Criterios de exclusión

Transformation of CLL to aggressive Non-Hodgkin's lymphoma (Richter's transformation or pro-lymphocytic leukemia)
Known central nervous system involvement
Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML)
An individual organ/ system impairment score of 4 as assessed by the CIRS definition limiting the ability to receive the treatment regimen of this trial with the exception of eyes, ears, nose, throat organ system
Participants with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
Inadequate renal function
History of prior malignancy, except for conditions as listed in the protocol if participants have recovered from the acute side effects incurred as a result of previous therapy
Use of investigational agents or concurrent anti-cancer treatment within the last 4 weeks of registration
Participants with active bacterial, viral, or fungal infection requiring systemic treatment within the last two months prior to registration
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
Hypersensitivity to chlorambucil, obinutuzumab, or venetoclax or to any of the excipients
Pregnant women and nursing mothers
Positive test results for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen \[HBsAg\] serology) or positive test result for hepatitis C (hepatitis C virus \[HCV\] antibody serology testing)
Participants with known infection with human immunodeficiency virus (HIV) or human T-cell leukemia virus-1 (HTLV-1)
Requires the use of warfarin, marcumar, or phenprocoumon
Received agents known to be strong and moderate Cytochrome P450 3A inhibitors or inducers within 7 days prior to the first dose of study drug

Intervenciones

drug

Chlorambucil

Chlorambucil 0.5 milligrams per kilogram (mg/kg) orally at Day 1 and Day 15 at of each 28 day cycle for 12 cycles.

drug

Venetoclax

Venetoclax, oral tablet: 20 mg daily during Cycle 1, Day 22-28; 50 mg daily during Cycle 2, Day 1-7; 100 mg daily during Cycle 2, Day 8-14; 200 mg daily during Cycle 2, Day 15-21; 400 mg daily during Cycle 2, Day 22-28 and on Day 1-28 for all subsequent cycles until the end of Cycle 12.

drug

Obinutuzumab

Obinutuzumab, IV infusion: 100 mg or 1000 mg, depending on splitting rules, at Cycle 1, Day 1 (if 100 mg was received on Day 1, 900 mg will be administered on Cycle 1, Day 2); 1000 mg at Cycle 1, Day 8 and Day 15; 1000 mg at Day 1 for all subsequent cycles until the end of Cycle 6

A Prospective, Open-Label, Multicenter Randomized Phase III Trial to Compare The Efficacy and Safety of A Combined Regimen of Obinutuzumab and Venetoclax Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients With CLL and Coexisting Medical Conditions

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Chlorambucil

Venetoclax

Obinutuzumab

Ubicaciones

Hospital Italiano

Patrocinadores