A Study of Motexafin Gadolinium for the Treatment of Chronic Lymphocytic Leukemia (CLL)

June 25, 2014 updated by: Pharmacyclics LLC.

Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

The purpose of this study is to determine if the drug motexafin gadolinium will be an effective treatment for patients who have chronic lymphocytic leukemia (CLL) that has come back after treatment or that has stopped responding to treatment.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Drug: Motexafin gadolinium

Study Type

Interventional

Enrollment

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Ohio
  - Columbus, Ohio, United States
    - Ohio State University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

At least 18 years old
Refractory or relapsed CLL
ECOG performance status score of 0, 1, or 2
Each patient must sign a study-specific informed consent form

Exclusion Criteria:

Laboratory values of:

Platelet count <30,000/uL
AST or ALT >2 x the upper limit of normal (ULN)
Total bilirubin >2 x ULN
Creatinine >2.0 mg/dL
Chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids, or systemic biologic anticancer therapy within 21 days before beginning study treatment
Women who are pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmacyclics LLC.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 21, 2004

First Submitted That Met QC Criteria

January 23, 2004

First Posted (Estimate)

January 26, 2004

Study Record Updates

Last Update Posted (Estimate)

June 26, 2014

Last Update Submitted That Met QC Criteria

June 25, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

PCYC-0216

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.