Alemtuzumab/Fludarabine for Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)

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.

Time frame: 28 days after last cycle with confirmation 2 months later

Population: ITT population (all enrolled and registered subjects).

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

Time frame: When CR is confirmed

Population: All participants for whom CR was confirmed

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.

Time frame: 28 days after last cycle with confirmation 2 months later

Population: 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

Time frame: 1 year after start of treatment

Population: Safety Population (all subjects treated)

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.

Time frame: from first date of confirmed response until relapse, or death, or study data cutoff date, whichever is earlier

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

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

Time frame: 1 year after start of treatment

Population: 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.