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

B-Cell Chronic Lymphocytic Leukemia Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00485966
• Other study ID #: C3-07-001
• Status: Withdrawn
• Phase: Phase 2
• First received: June 11, 2007
• Last updated: November 3, 2008
• Start date: June 2007
• Est. completion date: June 2008

Study information

• Verified date: November 2008
• Source: Cylene Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 25
• Est. completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• B-Cell Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

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

Locations

Country	Name	City	State
United States	University of New Mexico Cancer Research and Treatment Center	Albuquerque	New Mexico
United States	Tower Cancer Research Foundation	Beverly Hills	California
United States	Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	Oregon Health and Sciences University	Portland	Oregon
United States	Cancer Therapy and Research Center	San Antonio	Texas
United States	South Texas Accelerated Research Therapeutics (START)	San Antonio	Texas
United States	Mayo Clinic	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Cylene Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy
Primary	Safety
Secondary	Clinical benefit
Secondary	Pharmacodynamics
Secondary	Study drug blood levels
Secondary	Progression free survival