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

Sponsor
Point Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT00086203
Collaborator
(none)
19
Locations

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Completion date provided represents the completion date of the grant per OOPD records

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Completion Date :
Sep 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University of Arkansas for Medical Science Little Rock Arkansas United States 72205
    2 Ocala Oncology Center Ocala Florida United States 34474
    3 Gulfcoast Oncology Associates St. Petersburg Florida United States 33705
    4 Indiana Oncology/Hematology Consultants Indianapolis Indiana United States 46202
    5 Dana Farber Cancer Institute Boston Massachusetts United States 02115
    6 Hematology/Oncology Centers of the Northern Rockies Billings Montana United States 59101
    7 Nevada Cancer Institute Las Vegas Nevada United States 89135
    8 Queens Medical Associates, PC Fresh Meadows New York United States 11365
    9 Long Island Jewish Medical Center New Hyde Park New York United States 11040
    10 NYU Medical Center New York New York United States 10016
    11 James P. Wilmot Cancer Center/University of Rochester Rochester New York United States 14642
    12 Raleigh Hematology/Oncology Clinic Cary North Carolina United States 27511
    13 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    14 Cancer Care Associates/Oklahoma City Oklahoma City Oklahoma United States 73112
    15 Cancer Care Associates--Tulsa Tulsa Oklahoma United States 74136
    16 Cancer Centers of the Carolinas Seneca South Carolina United States 29672
    17 Texas Cancer Center/Abilene Abilene Texas United States 79606-5208
    18 MD Anderson Cancer Center Houston Texas United States 77030
    19 Virginia Oncology Associates-Lake Wright Cancer Center Norfolk Virginia United States 23502

    Sponsors and Collaborators

    • Point Therapeutics

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00086203
    Other Study ID Numbers:
    • PTH-203
    • FD-R-003021-01
    First Posted:
    Jun 29, 2004
    Last Update Posted:
    Mar 25, 2015
    Last Verified:
    Aug 1, 2006
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Lymphoid
    Leukemia, Lymphocytic, Chronic, B-Cell
    Rituximab

    Study Results

    No Results Posted as of Mar 25, 2015