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

Tracking Information
First Received Date ^ICMJE	January 21, 2004
Last Updated Date	April 2, 2009
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00076401 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study of Motexafin Gadolinium for the Treatment of Chronic Lymphocytic Leukemia (CLL)
Official Title ^ICMJE	Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Brief Summary	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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Allocation: Non-Randomized Control: Uncontrolled Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Leukemia Leukemia, Lymphocytic, Chronic
Intervention ^ICMJE	Drug: Motexafin gadolinium
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	27
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00076401
Responsible Party
Study ID Numbers ^ICMJE	PCYC-0216
Study Sponsor ^ICMJE	Pharmacyclics
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Pharmacyclics
Verification Date	August 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP