Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Point Therapeutics
Completion date provided represents the completion date of the grant per OOPD records
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Men or women ≥18 years of age
Histopathologically confirmed diagnosis of B-CLL expressing surface CD20 of any detectable intensity
Rai Stage III or IV. Rai Stages I and II with massive or progressive lymphadenopathy or hepatosplenomegaly.
Primary resistance to a fludarabine regimen (no PR or CR) or progressive disease within 1 year of a prior response
ECOG performance status 0, 1, or 2
Written informed consent
You may not be if
Therapy for CLL within 4 weeks of Study Day 1 (including chemotherapy, radiation, immunotherapy, cytokine or biologic \[with the exception of hematopoietic growth factors\]). Patients must have recovered from the adverse effects of prior therapy.
Known primary or secondary malignancy of the central nervous system
Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
Serum creatinine \>2.0mg/dL (\>176 micromol/L)
AST or ALT ≥3 x the upper limit of normal (ULN)
Total bilirubin ≥1.5 x ULN (unless secondary to Gilbert's)
Positive serology for hepatitis B (HBsAg) or hepatitis C (anti-HCV antibody)
Known positivity for HIV
Prior organ allograft
Concurrent comorbid medical conditions that, in the opinion of the investigator, preclude the safe delivery of the experimental treatment
Pregnant or nursing women
Clareo Health | Study of Talabostat and Rituximab in Advanced Chronic Lymphocytic Leukemia (CLL)