Exclusion Criteria
Patients who have received prior combination treatment with cyclophosphamide and fludarabine either concurrently or sequentially.
boolean
Patients who are refractory to fludarabine (or any nucleoside analogue). Refractory is defined as not achieving at least a PR for a minimum duration of 6 months.
boolean
Patients who have had prior treatment with interferon, rituximab or another monoclonal antibody
boolean
Patients who have had a prior allogeneic BMT or autologous BMT or peripheral stem cell transplant (PBSCT) or patients who are considered to be candidates for allogeneic or autologous BMT or PSCT as assessed by his/her treating physician
boolean
Fertile men or women of childbearing potential not using adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile).
boolean
Severe grade 3 or 4 non-hematological toxicity or prolonged (> 2 weeks) cytopenia on prior fludarabine regimen
boolean
Patients with a history of Fludarabine-induced or clinically significant autoimmune cytopenia as assessed by his/her treating physician (Coombs-positive patients without clinical signs of autoimmune hemolytic anemia are eligible for study entry)
boolean
Patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent
boolean
Patients with co - morbid conditions that would require long term use (> 1 month) of systemic corticosteroids during study treatment (e.g. chronic obstructive pulmonary disease [COPD]). Steroid use <= 1 month is permissible
boolean
Patients with active bacterial, viral, or fungal infection requiring systemic therapy
boolean
Patients with a history of severe cardiac disease; e.g. NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachyarrythmias requiring ongoing treatment, or unstable angina
boolean
Seizure disorders requiring anticonvulsant therapy
boolean
Severe chronic obstructive pulmonary disease with hypoxemia
boolean
Uncontrolled diabetes mellitus
boolean
Uncontrolled hypertension
boolean
Transformation to aggressive B-cell malignancy (e.g., large B-cell lymphoma, Richter’s syndrome, or prolymphocytic leukemia (PLL) )
boolean
Known infection with HIV, hepatitis B or hepatitis C
boolean
Treatment with any other investigational agent, or participating in another clinical trial within 30 days prior to entering this study
boolean
Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
boolean
Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
boolean
Eligibility summary
Will the patient participate in the trial?
boolean
Date of consent
date
specify reason
text
Investigator signature
text
Investigator Signature Date
date