Study of Motexafin Gadolinium (MGd) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Phase 2

Terminated

• Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

• Registration Number: NCT00100711
• Lead Sponsor: Pharmacyclics LLC.

Brief Summary

The primary purpose of this study is to determine if motexafin gadolinium may be an effective treatment for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Secondly, the duration of response and the time during which patients survive without chronic lymphocytic leukemia or small lymphocytic lymphoma worsening will be evaluated. Additionally, the patient's response to motexafin gadolinium will be compared to the response of the patient's cells in a laboratory to motexafin gadolinium.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-01-04
• Study First Submitted QC: 2005-01-04
• Study First Posted: 2005-01-05
• Primary Completion: 2010-02
• Disposition First Submitted: 2014-04-14
• Status Verified: 2014-05
• Disposition First Submitted QC: 2014-05-07
• Last Update Submitted: 2014-05-07
• Disposition First Posted: 2014-05-23
• Last Update Posted: 2014-05-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• ≥ 18 years old
• CLL as defined by the NCI 96 criteria (exception; patients may have bright surface immunoglobulin staining if negative for t[11;14] translocation or cyclin D1) or SLL as defined by WHO classification criteria and is refractory or relapsed as defined by one of the following: 1) Refractory disease- progressive disease while on therapy, or 2) Relapsed disease progressive disease after at least one treatment course of therapy with disease response or stabilization
• ECOG performance status score of 0, 1, or 2
• Willing and able to provide written informed consent

Exclusion Criteria

Laboratory Values of:

• Platelet count < 30,000/µL
• AST or ALT > 2 x ULN (upper limit of normal)
• Total bilirubin > 2 x ULN
• Creatinine > 2.0 mg/dL

and

• Chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids (> 10 mg oral prednisone or equivalent), or systemic biologic anticancer therapy within 21 days before beginning study treatment
• Greater than three prior regimens (where a regimen is defined as a treatment for CLL/SLL given initially or after disease progression)
• Uncontrolled hypertension
• Known history of porphyria (testing not required at screening)
• Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency (testing not required at screening)
• Known history of HIV infection (testing not required at screening)
• Pregnant or lactating (pregnancy test is required for all female patients of childbearing potential)
• Woman of childbearing potential or sexually active man unwilling to use adequate contraceptive protection
• Physical or mental condition that makes patient unable to complete specified follow-up assessments

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Complete and partial response rates

Secondary Outcome Measures

Name	Time	Method
Progression-free survival
Duration of response
Safety and tolerability

Trial Locations

Locations (3)

Northwestern University; 🇺🇸 Chicago, Illinois, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

The Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States