Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Conditions
Keywords
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Leukemia, Lymphoma, Motexafin Gadolinium, Relapsed Chronic Lymphocytic Leukemia, Relapsed Chronic Lymphocycic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Small Lymphocytic Lymphoma
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.
Interventions
DRUGMotexafin Gadolinium
Sponsors
Pharmacyclics LLC.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete and partial response rates | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
| Duration of response | — |
| Safety and tolerability | — |
Countries
United States
Outcome results
None listed