Participants evaluated for therapeutic clinical response according to National Cancer Institute (NCI) response criteria, 28 days after 4 or 6 treatment cycles. Response confirmation involved bone marrow biopsy and aspirate performed 2 months after final treatment. CR requires for at least 2 months: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count (CBC); confirmed by bone marrow aspirate and biopsy 2 months later with lymphocytes <30% of nucleated cells and procedure repeated in 4 weeks if hypocellular.

ITT population (all enrolled and registered subjects).

Participant had either complete response (CR) or partial response (PR) at 28 days after last treatment cycle (date of OR) and at Months 2 follow-up. PR requires for at least 2 months: 50% decrease from Baseline in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence or absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin, or 50% improvement from Baseline for these parameters without transfusions, nodular CR or persistent anemia/thrombocytopenia unrelated to disease.

ITT Population (all subjects enrolled and registered).

Percentage of participants alive 1 year after the first dose date, described as Kaplan-Meier estimate at 1 year

Safety Population (all subjects treated)

Percentage of participants who survived progression-free at 1 year, described as Kaplan-Meier estimate at 1 year

ITT population (all subjects enrolled and registered). As three subjects never received study medication, they were to be censored at day 1 for all time-to-event analyses. Thus, the Kaplan-Meier estimates beyond day one are the same for both, the ITT and the safety population.

Participant had either complete response (CR) or partial response (PR) at different observation times (after 90 days; after 180 days; after 270 days). PR requires for at least 2 months: 50% decrease from Baseline in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence or absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin, or 50% improvement from Baseline for these parameters without transfusions, nodular CR or persistent anemia/thrombocytopenia unrelated to disease.

Subjects who achieved Overall Response (OR) defined as number of subjects who achieved CR + number of subjects who achieved PR

Presence of MRD was assessed by laboratory testing of molecular responses in blood and bone marrow samples.

All participants for whom CR was confirmed