Prospective, open-label, phase IIb/III study to evaluate the risk of SLT and optimization of venetoclax initiation in combination with obinutuzumab or acalabrutinib with different ramp-up periods in previously treatment-naive CLL patients

THE PRIMARY OBJECTIVE IS TO ASSESS THE INCIDENCE OF TREATMENT-EMERGENT LABORATORY TLS ACCORDING TO HOWARD'S CRITERIA (APPENDIX D) OR HYPERKALEMIA (POTASSIUM > 6.0 MMOL/L) REQUIRING CLINICAL INTERVENTION AS ASSESSED BY THE INDEPENDENT REVIEW COMMITTEE (IRC) IN PREVIOUSLY UNTREATED CLL SUBJECTS WHO HAVE REACHED A MEDIAN LEVEL (ANY LYMPH NODE). (CRI) IN PREVIOUSLY UNTREATED CLL PATIENTS WITH A MEDIAN EXTENT (ANY LYMPH NODE [LN] OF 5 CM). LYMPH NODES [LN] FROM 5 CM TO < 10 CM OR ABSOLUTE LYMPHOCYTE COUNT [ALC] = 25 &TIMES; 109 /L) TUMOR BURDEN WITH CRCL OF AT LEAST 80 ML/MIN OR LOW TUMOR BURDEN (ALL LN < 5 CM AND ALC < 25 &TIMES; 109 /L) (REGARDLESS OF CRCL LEVEL) AFTER CYTOREDUCTION THERAPY, DURING THE VENETOCLAX BOOST PERIOD (5, 6 OR 7 WEEKS).