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B-Cell Chronic Lymphocytic LeukemiaPhase 2NCT00485966

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

A Phase 2 study testing CX-3543 in people with B-Cell Chronic Lymphocytic Leukemia, run by Cylene Pharmaceuticals at 7 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-Cell Chronic Lymphocytic Leukemia
What is being tested?
CX-3543
How many people
25 participants
Where
7 sitesUnited States
Study dates
Jun 2007to Jun 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87131-0001

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Oregon Health and Sciences University

    Portland, Oregon, 97239-3098

  • Cancer Therapy and Research Center

    San Antonio, Texas, 78229

  • South Texas Accelerated Research Therapeutics (START)

    San Antonio, Texas, 78229

  • Mayo Clinic

    Scottsdale, Arizona, 85259

Other trials in United States

About this study

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)

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).

Read the 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.

Being tested
CX-3543
Keywords
Adult Leukemia, CLL, B-CLL, Chronic Lymphocytic Leukemia, B-cell CLL
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Leukemia, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CX-3543Drug

    360 mg/m2 daily x 5 q 21 days

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy

  2. Safety

Secondary outcomes (4)

  1. Clinical benefit

  2. Pharmacodynamics

  3. Study drug blood levels

  4. Progression free survival

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2007 (estimated)
  2. Study startJun 2007
  3. Study completionJun 2008 (estimated)

Why it stopped: This study was withdrawn prior to patient enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00485966
Sponsor's protocol ID
C3-07-001
Status last verified
Nov 2008
First submitted
11 Jun 2007
Last updated
5 Nov 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CX-3543 in people with B-Cell Chronic Lymphocytic Leukemia, run by Cylene Pharmaceuticals at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 5 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00485966.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2008.

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