Status:
TERMINATED
Study of Motexafin Gadolinium (MGd) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Lead Sponsor:
Pharmacyclics LLC.
Conditions:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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). Second...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00100711
Start Date
October 1 2004
Last Update
May 23 2014
Active Locations (3)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
The Mayo Clinic
Rochester, Minnesota, United States, 55905
3
The Ohio State University
Columbus, Ohio, United States, 43210-1240