Clinical trial NCT00338494 (phase 1, status: completed)
Conditions: b-cell lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: clofarabine
SMILES: [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C
Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients who are at least 18 years old

          -  Histologically confirmed low grade or intermediate-grade B-cell lymphoma

          -  Relapsed or refractory to at least one standard chemotherapy regimen. Patients who
             have received Rituximab alone without having received a cytotoxic agent are not
             eligible.

          -  Measurable disease, defined by the Cheson lymphoma criteria.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

          -  Life expectancy greater than 12 weeks

          -  Laboratory values obtained ≤2 weeks prior to entry

               -  Absolute neutrophil count (ANC) ≥ 1000 x 10 9/L

               -  White blood cell (WBC) count > 2.5 x 10 9/L

               -  Platelets ≥ 75 x 10 9/L

               -  Hemoglobin (Hg) > 9.0 g/dL

               -  Total bilirubin ≤2.0 mg/dL

               -  Aspartate transaminase (AST)/alanine transaminase (ALT) ≤3 × upper limit of
                  normal (ULN)

               -  Serum creatinine ≤2.0 mg/dL

          -  Normal cardiac function, defined as an ejection fraction ≥45% determined by
             pretreatment radionuclide ventriculography (RVG) or echocardiogram.

          -  Capable of understanding the investigational nature, potential risks and benefits of
             the study, and able to provide valid informed consent.

          -  Female patients of childbearing potential must have a negative serum pregnancy test
             within 2 weeks prior to enrollment.

          -  Male and female patients must use an effective contraceptive method during the study
             and for a minimum of 6 months after study treatment.

        Exclusion Criteria:

          -  Previously untreated B-cell lymphoma.

          -  Received previous treatment with clofarabine.

          -  Patients with known AIDS-related or HIV-positive lymphoma.

          -  Autologous bone marrow or stem cell transplant within 6 months of study entry.

          -  Prior radiotherapy to the only site of measurable disease.

          -  Any medical condition that requires chronic use of oral high-dose corticosteroids
             greater than 20 mg/day prednisone.

          -  Active autoimmune thrombocytopenia.

          -  Use of investigational agents within 30 days or any anticancer therapy within 3 weeks
             before study entry. The patient must have recovered from all acute toxicities from any
             previous therapy.

          -  Patients with an active, uncontrolled systemic infection considered to be
             opportunistic, life threatening, or clinically significant at the time of treatment or
             with a known or suspected fungal infection (ie, patients on parenteral antifungal
             therapy).

          -  Active secondary malignancy.

          -  Pregnant or lactating patients.

          -  Any significant concurrent disease, illness, or psychiatric disorder that would
             compromise patient safety or compliance, interfere with consent, study participation,
             follow up, or interpretation of study results.

          -  Patients with active or untreated central nervous system (CNS) lymphoma.