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

This study is currently recruiting patients.

Sponsored by: Point Therapeutics
Information provided by: Point Therapeutics

Purpose

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

MedlinePlus related topics:  Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Eligibility

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

Criteria

INCLUSION CRITERIA:

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

Location and Contact Information

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

More Information

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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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