Clinical trial NCT00485966: Study Evaluating Effects of CX-3543 in Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: B-Cell Chronic Lymphocytic Leukemia
Keywords: Adult Leukemia
CLL
B-CLL
Chronic Lymphocytic Leukemia
B-cell CLL
Lead sponsor: Cylene Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-06-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy
measure: Safety
Secondary outcomes:
measure: Clinical benefit
measure: Pharmacodynamics
measure: Study drug blood levels
measure: Progression free survival
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Beverly Hills
country: United States
facility: Tower Cancer Research Foundation
state: California
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Research and Treatment Center
state: New Mexico
city: Portland
country: United States
facility: Oregon Health and Sciences University
state: Oregon
city: San Antonio
country: United States
facility: Cancer Therapy and Research Center
state: Texas
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics (START)
state: Texas
city: La Crosse
country: United States
facility: Gundersen Lutheran Medical Center
state: Wisconsin
Study officials:
References: