Clinical trial NCT00321724 (phase 2, status: completed)
Conditions: b-cell chronic lymphocytic leukemia, refractory chronic lymphocytic leukemia
ICD codes: C91.11, C91.12, C91.10, A87.2, K52.832, D72.111, C91.11, C91.12, C91.10
Drugs: cediranib maleate
SMILES: COC1=CC2=C(C=C1OCCCN1CCCC1)N=CN=C2OC1=C(F)C2=C(NC(C)=C2)C=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Histological confirmation of B-cell chronic lymphocytic leukemia (B-CLL)

               -  Peripheral blood lymphocyte count > 5,000/mm³

               -  Small to moderate peripheral blood lymphocytes with ≤ 55% prolymphocytes

               -  Bone marrow aspirate with ≥ 30% lymphoid cells

               -  Monoclonality of B lymphocytes by immunophenotyping, demonstrating all of the
                  following:

                    -  B-cell markers with CD5 antigen in the absence of other pan-T-cell markers
                       (CD3, CD2, etc.)

                    -  CD19 and/or CD20

                    -  Expression of CD23 on the CLL cells OR dim B-cell expression of kappa or
                       lambda light chains

          -  Disease must be refractory to or progressive after treatment with at least 1 course
             containing a purine nucleoside analog (e.g., fludarabine, cladribine, or pentostatin)

          -  Life expectancy > 6 months

          -  ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 50,000/mm³

          -  Hemoglobin ≥ 8 g/dL

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

               -  Patients with Gilbert's syndrome may have a bilirubin ≥ 1.5 times ULN

          -  AST and ALT ≤ 2.5 times ULN

          -  Creatinine ≤ 1.5 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No history of allergies to compounds similar to AZD2171

          -  QTc prolongation < 500 msec

          -  No other significant ECG abnormality

          -  No history of familial long QT syndrome

          -  Proteinuria < 1+ by dipstick OR protein < 1 g/24 hr urine collection

          -  No known HIV positivity

          -  No New York Heart Association (NYHA) class III or IV disease

               -  NYHA class II disease controlled with treatment and monitoring allowed

          -  No other uncontrolled illness including, but not limited to, the following:

               -  Hypertension

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

               -  Psychiatric illness or social situations that would limit compliance

          -  See Disease Characteristics

          -  More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C),
             radiotherapy, anti-vascular endothelial growth factor (VEGF) treatment, or major
             surgery and recovered

          -  More than 30 days since prior investigational agents

          -  No concurrent drugs or biologics with proarrhythmic potential

          -  No other concurrent investigational agents

          -  No other concurrent anticancer therapy