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

Sponsor

Pharmacyclics LLC. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00076401

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Leukemia, Lymphocytic, Chronic	Drug: Motexafin gadolinium	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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