Study of Talabostat and Rituximab in Advanced Chronic Lymphocytic Leukemia (CLL)
Data Collection
Chronic Disease+11
+ Hematologic Diseases
+ Immune System Diseases
Treatment Study
Summary
Completion date provided represents the completion date of the grant per OOPD records
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
INCLUSION CRITERIA: * 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 EXCLUSION CRITERIA: * 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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 19 locations
Ocala Oncology Center
Ocala, United StatesGulfcoast Oncology Associates
St. Petersburg, United StatesIndiana Oncology/Hematology Consultants
Indianapolis, United States