Study of Talabostat and Rituximab in Advanced Chronic Lymphocytic Leukemia (CLL)
2 other identifiers
interventional
N/A
1 country
19
Brief Summary
The objective of this study is to assess the efficacy and safety of talabostat and rituximab in patients with advanced CLL who failed to respond, or have progressed following a prior response, to a fludarabine regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2004
CompletedFirst Posted
Study publicly available on registry
June 29, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedMarch 25, 2015
August 1, 2006
June 28, 2004
March 24, 2015
Conditions
Interventions
Eligibility Criteria
You may qualify 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 qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
University of Arkansas for Medical Science
Little Rock, Arkansas, 72205, United States
Ocala Oncology Center
Ocala, Florida, 34474, United States
Gulfcoast Oncology Associates
St. Petersburg, Florida, 33705, United States
Indiana Oncology/Hematology Consultants
Indianapolis, Indiana, 46202, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Hematology/Oncology Centers of the Northern Rockies
Billings, Montana, 59101, United States
Nevada Cancer Institute
Las Vegas, Nevada, 89135, United States
Queens Medical Associates, PC
Fresh Meadows, New York, 11365, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
NYU Medical Center
New York, New York, 10016, United States
James P. Wilmot Cancer Center/University of Rochester
Rochester, New York, 14642, United States
Raleigh Hematology/Oncology Clinic
Cary, North Carolina, 27511, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Cancer Care Associates/Oklahoma City
Oklahoma City, Oklahoma, 73112, United States
Cancer Care Associates--Tulsa
Tulsa, Oklahoma, 74136, United States
Cancer Centers of the Carolinas
Seneca, South Carolina, 29672, United States
Texas Cancer Center/Abilene
Abilene, Texas, 79606-5208, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Virginia Oncology Associates-Lake Wright Cancer Center
Norfolk, Virginia, 23502, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 28, 2004
First Posted
June 29, 2004
Study Completion
September 1, 2007
Last Updated
March 25, 2015
Record last verified: 2006-08