Study Evaluating Effects of CX-3543 in Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia

November 3, 2008 updated by: Cylene Pharmaceuticals

A Phase 2, Multi-Center, Open Label Study Evaluating Clinical Efficacy, Safety, and Pharmacodynamic Effects of Quarfloxacin (CX-3543) in Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)

This is a Phase 2, open-label, multicenter, efficacy, safety, and pharmacodynamic study of CX-3543 in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (CLL).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The purpose of this trial is to evaluate the response rate, safety, pharmacodynamic effects, and duration of response of CX-3543 in patients with relapsed or refractory B-cell CLL.

Study Type

Interventional

Enrollment (Anticipated)

25

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
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
    • California
      • Beverly Hills, California, United States, 90211
        • Tower Cancer Research Foundation
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-0001
        • University of New Mexico Cancer Research and Treatment Center
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Oregon Health and Sciences University
    • Texas
      • San Antonio, Texas, United States, 78229
        • Cancer Therapy and Research Center
      • San Antonio, Texas, United States, 78229
        • South Texas Accelerated Research Therapeutics (START)
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Medical 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:

  • Patients with B-cell CLL with indications for treatment by National Cancer Institute (NCI) Working Group criteria.
  • Measurable disease (lymphocytes ≥ 5,000/microliter, or palpable lymphadenopathy or bone marrow involvement > 30%).
  • Males and females 18 years of age or older.
  • Received a minimum of one prior purine analog-based chemotherapy regimen (e.g., fludarabine, cladribine, or pentostatin) and one monoclonal antibody therapy (e.g., Campath or Rituxan) but ≤ 4 chemotherapy regimens.
  • Patients must have central intravenous (IV) access, or agree to the insertion of a central line.
  • All previous cancer therapies, radiation, hormonal therapy and surgery, must have been discontinued at least 28 days prior to the start of treatment. Any cytotoxic chemotherapy must have been discontinued 28 days prior to the start of treatment. Acute toxicities from prior therapy must have resolved to Grade ≤ 1 above baseline.
  • Normal oxygen saturation with pulse oximetry on room air.
  • Hemoglobin ≥ 9 gm/dL (may be post-transfusion).
  • Platelet count ≥ 25,000/microliter.
  • Total bilirubin < 2 X upper limit of normal (ULN), and ALT and AST < 2 x ULN.
  • Serum creatinine within normal limits OR calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above the upper normal limit for the institution
  • ECOG Performance Status ≤ 1.
  • Anticipated survival of at least 3 months.
  • For men and women of child-producing potential, use of effective contraceptive methods during the study and for one month after discontinuation of treatment.
  • Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return to the clinic for required assessments.

Exclusion Criteria:

  • Pregnant or nursing women.
  • Severe chronic obstructive pulmonary disease with hypoxemia or an uncorrectable pulmonary compromise.
  • Seizures not controlled by anticonvulsant therapy.
  • Participation in any investigational drug study within 28 days before quarfloxacin administration.
  • Patients with second malignancy requiring active treatment.
  • Active symptomatic bacterial, fungal, or viral infection including active HIV or viral (A, B, or C) hepatitis.
  • Clinically significant bleeding event within the last 3 months, unrelated to trauma, or underlying condition that would be expected to result in a bleeding diathesis.
  • Patients who have exhibited allergic reactions to a similar structural compound (e.g., fluoroquinolones) or formulation (containing buffers and/or polyethylene glycol).
  • Patients with life- or function-threatening CLL complications (e.g., cord compression, hemolytic crisis, urinary tract obstruction).
  • Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any of the study's endpoints.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety
Efficacy

Secondary Outcome Measures

Outcome Measure
Progression free survival
Pharmacodynamics
Clinical benefit
Study drug blood levels

Collaborators and Investigators

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

Sponsor

Cylene Pharmaceuticals

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 Start

June 1, 2007

Study Completion (ANTICIPATED)

June 1, 2008

Study Registration Dates

First Submitted

June 11, 2007

First Submitted That Met QC Criteria

June 12, 2007

First Posted (ESTIMATE)

June 13, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

November 5, 2008

Last Update Submitted That Met QC Criteria

November 3, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C3-07-001

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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