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

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

This study is ongoing, but not recruiting participants.

Sponsored by:	Pharmacyclics
Information provided by:	Pharmacyclics
ClinicalTrials.gov Identifier:	NCT00076401

Purpose

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.

Condition	Intervention	Phase
Leukemia Leukemia, Lymphocytic, Chronic	Drug: Motexafin gadolinium	Phase II

MedlinePlus related topics:

Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for:

Motexafin gadolinium Motexafin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Pharmacyclics:

Estimated Enrollment:

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076401

Locations


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

Sponsors and Collaborators

Pharmacyclics

More Information

Study ID Numbers:	PCYC-0216
First Received:	January 21, 2004
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00076401
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pharmacyclics:

CLL

chronic lymphocytic leukemia

relapsed chronic lymphocytic leukemia

refractory chronic lymphocytic leukemia

Leukemia

Motexafin gadolinium

Chronic leukemia

Lymphocytic leukemia, chronic

Study placed in the following topic categories:

Chronic lymphocytic leukemia

Lymphatic Diseases

Leukemia

Leukemia, Lymphoid

Immunoproliferative Disorders

Leukemia, Lymphocytic, Chronic, B-Cell

Motexafin gadolinium

Lymphoproliferative Disorders

Leukemia, B-Cell

Additional relevant MeSH terms:

Photosensitizing Agents

Neoplasms

Neoplasms by Histologic Type

Radiation-Sensitizing Agents

Immune System Diseases

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Dermatologic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008