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

NCT00485966 | Withdrawn Phase 2

• 1 other identifier: C3-07-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 7

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).

Conditions

B-Cell Chronic Lymphocytic Leukemia

Keywords

Adult Leukemia; CLL; B-CLL; Chronic Lymphocytic Leukemia; B-cell CLL

Outcome Measures

Primary Outcomes (2)

• Efficacy

• Safety

Secondary Outcomes (4)

• Clinical benefit

• Pharmacodynamics

• Study drug blood levels

• Progression free survival

Interventions

CX-3543 DRUG

360 mg/m2 daily x 5 q 21 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cylene Pharmaceuticals: lead

Study Sites (7)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Tower Cancer Research Foundation

Beverly Hills, California, 90211, United States

Location

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, 87131-0001, United States

Location

Oregon Health and Sciences University

Portland, Oregon, 97239-3098, United States

Location

Cancer Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, 78229, United States

Location

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia; Leukemia, B-Cell

Interventions

CX 3543

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 11, 2007
• First Posted: June 13, 2007
• Study Start: June 1, 2007
• Study Completion: June 1, 2008
• Last Updated: November 5, 2008

Record last verified: 2008-11

Locations

US (7)