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

Pharmacyclics

Status and phase: Terminated; Phase 2

Conditions: Leukemia; Leukemia, Lymphocytic, Chronic

Treatments: Drug: Motexafin gadolinium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00076401

PCYC-0216

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)