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Study of Talabostat and Rituximab in Advanced Chronic Lymphocytic Leukemia (CLL)
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Point Therapeutics
FDA Office of Orphan Products Development
Information provided by: FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier: NCT00086203
  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 Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Talabostat mesylate (PT-100) tablets
Drug: Rituximab
Phase II

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Rituximab Talabostat mesylate Talabostat
U.S. FDA Resources
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 older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00086203

Locations
United States, Arkansas
University of Arkansas for Medical Science
Little Rock, Arkansas, United States, 72205
United States, Florida
Gulfcoast Oncology Associates
St. Petersburg, Florida, United States, 33705
Ocala Oncology Center
Ocala, Florida, United States, 34474
United States, Indiana
Indiana Oncology/Hematology Consultants
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Montana
Hematology/Oncology Centers of the Northern Rockies
Billings, Montana, United States, 59101
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, New York
James P. Wilmot Cancer Center/University of Rochester
Rochester, New York, United States, 14642
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Queens Medical Associates, PC
Fresh Meadows, New York, United States, 11365
NYU Medical Center
New York, New York, United States, 10016
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Raleigh Hematology/Oncology Clinic
Cary, North Carolina, United States, 27511
United States, Oklahoma
Cancer Care Associates/Oklahoma City
Oklahoma City, Oklahoma, United States, 73112
Cancer Care Associates--Tulsa
Tulsa, Oklahoma, United States, 74136
United States, South Carolina
Cancer Centers of the Carolinas
Seneca, South Carolina, United States, 29672
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Texas Cancer Center/Abilene
Abilene, Texas, United States, 79606-5208
United States, Virginia
Virginia Oncology Associates-Lake Wright Cancer Center
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Point Therapeutics
  More Information

Study ID Numbers: PTH-203, FD-R-003021-01
Study First Received: June 28, 2004
Last Updated: August 2, 2006
ClinicalTrials.gov Identifier: NCT00086203  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Chronic lymphocytic leukemia
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Rituximab
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-cell, chronic
Lymphoproliferative Disorders
Leukemia, B-Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009