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

NCT ID: NCT00076401

Last Updated: 2014-06-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL

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.

Conditions

Leukemia; Leukemia, Lymphocytic, Chronic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Motexafin gadolinium

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharmacyclics LLC.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ohio State University Medical Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

PCYC-0216

Identifier Type: -

Identifier Source: org_study_id