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

March 24, 2015 updated by: Point Therapeutics
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Point Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion

September 1, 2007

Study Registration Dates

First Submitted

June 28, 2004

First Submitted That Met QC Criteria

June 28, 2004

First Posted (ESTIMATE)

June 29, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

August 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTH-203
  • FD-R-003021-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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