Study of Talabostat and Rituximab in Advanced Chronic Lymphocytic Leukemia (CLL)

Completed · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia

In brief

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.

Key facts

Study ID

NCT00086203

Run by

Point Therapeutics

Expected to finish

2007-09-01

Last updated by the study team

2015-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of Arkansas for Medical Science — Little Rock, Arkansas, United States
• Ocala Oncology Center — Ocala, Florida, United States
• Gulfcoast Oncology Associates — St. Petersburg, Florida, United States
• Indiana Oncology/Hematology Consultants — Indianapolis, Indiana, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Hematology/Oncology Centers of the Northern Rockies — Billings, Montana, United States
• Nevada Cancer Institute — Las Vegas, Nevada, United States
• Queens Medical Associates, PC — Fresh Meadows, New York, United States
• Long Island Jewish Medical Center — New Hyde Park, New York, United States
• NYU Medical Center — New York, New York, United States
• James P. Wilmot Cancer Center/University of Rochester — Rochester, New York, United States
• Raleigh Hematology/Oncology Clinic — Cary, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Cancer Care Associates/Oklahoma City — Oklahoma City, Oklahoma, United States
• Cancer Care Associates--Tulsa — Tulsa, Oklahoma, United States
• Cancer Centers of the Carolinas — Seneca, South Carolina, United States
• Texas Cancer Center/Abilene — Abilene, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Virginia Oncology Associates-Lake Wright Cancer Center — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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