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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00485966
Recruitment Status : Withdrawn (This study was withdrawn prior to patient enrollment)
First Posted : June 13, 2007
Last Update Posted : November 5, 2008
Information provided by:
Cylene Pharmaceuticals

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
B-Cell Chronic Lymphocytic Leukemia Drug: CX-3543 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : June 2007
Estimated Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: CX-3543
    360 mg/m2 daily x 5 q 21 days

Primary Outcome Measures :
  1. Efficacy
  2. Safety

Secondary Outcome Measures :
  1. Clinical benefit
  2. Pharmacodynamics
  3. Study drug blood levels
  4. Progression free survival

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00485966

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United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, California
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
United States, New Mexico
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131-0001
United States, Oregon
Oregon Health and Sciences University
Portland, Oregon, United States, 97239-3098
United States, Texas
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States, 78229
United States, Wisconsin
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Sponsors and Collaborators
Cylene Pharmaceuticals
Layout table for additonal information Identifier: NCT00485966    
Other Study ID Numbers: C3-07-001
First Posted: June 13, 2007    Key Record Dates
Last Update Posted: November 5, 2008
Last Verified: November 2008
Keywords provided by Cylene Pharmaceuticals:
Adult Leukemia
Chronic Lymphocytic Leukemia
B-cell CLL
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell