Clinical trial NCT01392079 (phase 2, status: completed)
Conditions: chronic lymphocytic leukemia
ICD codes: C91.11, C91.12, C91.10
Drugs: alemtuzumab
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          1. The patient has CLL requiring treatment (Binet C or A/B with "active disease"
             according to the NCI criteria).

          2. One or both of the following is true:

               -  The patient's disease is refractory to a previous fludarabine-containing regimen,
                  defined as no CR or PR according to NCI criteria, or progression within 6 months
                  after a fludarabine-containing regime. (N.B.: Within the framework of this trial,
                  the term "fludarabine-refractory" is synonymous to a refractory status to any
                  established purine analogue (i.e. pentostatin, cladribine); this also encompasses
                  bendamustine, as this drug molecule contains both an alkylating and a purine
                  analogue moiety. Acc. to experimental findings and clinical experience, its
                  mechanism of action differs distinctly from that of a pure alkylator (Cheson et
                  al., 2009, Leoni et al., 2008)).

               -  17p deletion is present (irrespective of whether previously treated or
                  untreated).

          3. The patient is at least 18 years of age.

          4. The patient's performance status is 0, 1 or 2 on the WHO/ECOG scale.

          5. Any previous chemotherapy and/or immunotherapy ended at least four weeks before the
             first study treatment with alemtuzumab.

          6. The patient has recovered from all previous chemotherapy and/or immunotherapy.

          7. For fertile men and for women of childbearing potential: Adequate contraception (oral
             contraceptives, intrauterine device or barrier method in conjunction with spermicidal
             jelly).

          8. The patient has given written informed consent to participate in the study.

        Exclusion Criteria:

          1. The patient has received more than five different prior therapeutic regimens.

          2. Any major organ dysfunction is present (e.g. unstable angina pectoris, NYHA III/IV
             heart insufficiency, significant coronary stenoses, uncontrolled diabetes mellitus,
             uncontrolled hypertension, pulmonary disease with hypoxemia, renal failure).

          3. Any of the following laboratory values are found at the screening visit to be >2 × the
             upper limit of the normal range: serum creatinine, serum bilirubin, ASAT, ALAT.

          4. Any active infection is present.

          5. B-PLL or Richter transformation is diagnosed or suspected (e.g. symptoms or cytology).

          6. There is involvement of the central nervous system.

          7. The patient is known to be positive for human immunodeficiency virus (HIV).

          8. CMV viremia is present, as demonstrated by pp65 EA or CMV-DNA.

          9. The patient has previously been treated with alemtuzumab. (Exception: alemtuzumab used
             in a "non-therapeutic" context, i.e. administered as part of a conditioning regimen
             prior to SCT).

         10. The patient has received autologous or allogeneic SCT within the past six months.

         11. The patient is receiving long-term systemic treatment with corticosteroids or has
             received such treatment in the four weeks before first treatment with alemtuzumab.

         12. Any additional active malignancy is present.

         13. The patient has ever had an anaphylactic response to humanized antibodies.

         14. For female patients: The patient is pregnant or lactating.

         15. The patient has a history of drug or alcohol abuse that might lead to inability to
             comply with the protocol.