Low Dose Alemtuzumab for Consolidation and Maintenance of Patients With B-Cell Chronic Lymphocytic Leukemia

Inclusion Criteria:

* B-CLL diagnosis taken consideration of NCI criteria.
* In case of CR: positive MRD status
* At least achieving a PR to the last line of antitumor therapy given and than at least PR is still present after a follow-up of 3-6 months after the last antitumor course (wash-out period)
* Age \>18 years and \< 75 years.
* WHO performance status 0-II.
* ANC ≥1.0 x 109/L
* Platelet count ≥50 x 109/L
* Negative pregnancy test in fertile females
* Anticipated life expectancy ≥ 12 months
* Signed informed consent
* Fertile men or women of childbearing potential using adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)

Exclusion Criteria:

* Elapsed time of less than 3 months or more than 6 months since last dose of previous antitumor therapy
* Previous Alemtuzumab administration.
* Contraindication for Alemtuzumab
* More than 2 previous treatment regimens
* SD or PD on last antitumor therapy
* Persistent CLL symptoms in clinical need of further antitumor therapy
* History of severe pneumocytis carinii infection (PCP)
* HIV positive
* Active hepatitis or a history of prior viral hepatitis B or hepatitis C, or positive hepatitis B serologies without prior immunization
* Active viral, fungal or bacterial infection.
* Active autoimmune hemolytic anemia or active autoimmune thrombocytopenia.
* Severe concurrent diseases or mental disorders.
* Significant renal dysfunction ( serum creatinine ≥150 µmol/l or creatinine clearance \< 30 ml/min)
* Significant hepatic dysfunction (total bilirubin or transaminases \>2 times ULN)
* Pregnancy or lactation.
* Active secondary malignancy.
* Participating in other clinical trials.
* Transformation to aggressive B-cell malignancy (e.g., large B-cell lymphoma, Richter's syndrome, or prolymphocytic leukemia (PLL);
* Bulky disease requiring anti-tumor therapy.
* Planned or previous BMT