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

This study has been completed.

First Received on January 21, 2004. Last Updated on April 2, 2009 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Motexafin gadolinium Motexafin

U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00076401 History of Changes
Other Study ID Numbers:	PCYC-0216
Study First Received:	January 21, 2004
Last Updated:	April 2, 2009
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

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders

Immune System Diseases
Motexafin gadolinium
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Dermatologic Agents

ClinicalTrials.gov processed this record on February 12, 2012