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.

Condition	Treatment or Intervention	Phase
Chronic Lymphocytic Leukemia	Drug: Talabostat (PT-100) tablets  Drug: Rituximab	Phase II

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Eric J. Haltom      617-933-2143 

Arkansas
      University of Arkansas Medical Sciences, Little Rock,  Arkansas,  72205,  United States; Recruiting
Indiana
      Indiana Hematology Oncology Consultants, Indianapolis,  Indiana,  46202,  United States; Recruiting
Montana
      Hematology/Oncology Centers of the Northern Rockies, Billings,  Montana,  59107,  United States; Recruiting
New York
      James P. Wilmot Cancer Center, Rochester,  New York,  14642,  United States; Recruiting
      Long Island Jewish Medical Center, New Hyde Park,  New York,  11040,  United States; Recruiting
      Queens Medical Research, Fresh Meadows,  New York,  11365,  United States; Recruiting
      New York University, New York,  New York,  10016,  United States; Recruiting
North Carolina
      Wake Forest University School of Medicine, Winston Salem,  North Carolina,  27157,  United States; Recruiting
Texas
      MD Anderson Cancer Center, Houston,  Texas,  77030,  United States; Recruiting

Study ID Numbers:  PTH-203
Record last reviewed:  February 2005
Last Updated:  February 8, 2005
Record first received:  June 28, 2004
ClinicalTrials.gov Identifier:  NCT00086203
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08