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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by FDA Office of Orphan Products Development.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00086203
First received: June 28, 2004
Last updated: August 2, 2006
Last verified: August 2006
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by FDA Office of Orphan Products Development:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Ocala Oncology Center
Ocala, Florida, United States, 34474
Gulfcoast Oncology Associates
St. Petersburg, Florida, United States, 33705
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
Queens Medical Associates, PC
Fresh Meadows, New York, United States, 11365
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
NYU Medical Center
New York, New York, United States, 10016
James P. Wilmot Cancer Center/University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Raleigh Hematology/Oncology Clinic
Cary, North Carolina, United States, 27511
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
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
Texas Cancer Center/Abilene
Abilene, Texas, United States, 79606-5208
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Virginia
Virginia Oncology Associates-Lake Wright Cancer Center
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Point Therapeutics
  More Information

No publications provided

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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014