Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
With
Biogen
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age ≥18 years
Established diagnosis of B-cell CLL by NCI Working Group criteria
≤1 previous line of chemotherapy
Expected survival \>6 months
Acceptable hematologic status, liver function, renal function, and pulmonary function
Negative serum pregnancy test for both pre-menopausal women and for women who are \< 2 years after the onset of menopause
Written informed consent
You may not be if
Prior treatment with interferon, rituximab or other monoclonal antibody
Prior allogeneic bone marrow transplant (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 their treating physician
Fertile men or women of childbearing potential not using adequate contraception
Severe Grade 3 or 4 non-hematological toxicity or prolonged (\> 2 weeks) Grade 3 or 4 cytopenia on prior fludarabine or nucleoside analogue regimen
History of fludarabine-induced or clinically significant autoimmune cytopenia
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 ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone with curative intent.
Medical conditions requiring long term use (\> 1 month) of systemic corticosteroids
Active bacterial, viral, or fungal infection requiring systemic therapy
