Lymphoma, Non-Hodgkin's Lymphoma
Conditions
Keywords
Lymphoma, Non-Hodgkin's Lymphoma, Indolent lymphoma, Relapsed lymphoma, Refractory lymphoma, Motexafin gadolinium
Brief summary
The primary purpose of this study is to find out if motexafin gadolinium may be an effective treatment for patients with non-Hodgkin's lymphoma (NHL). Secondly, the safety and side effects of motexafin gadolinium will be evaluated.
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 * Refractory or relapsed indolent NHL. Eligible WHO histologies include follicular NHL (Grades 1, 2, and 3); marginal zone nodal; marginal zone splenic; and mucosa-associated lymphoid tissue (MALT) types * Failed ≥ 1 previous regimens, one of which must have contained rituximab as either a single agent or in combination with chemotherapy * ECOG performance status score either 0 or 1 * Willing and able to provide written informed consent
Exclusion criteria
Laboratory values of: * Platelet count \< 50,000/µL * AST or ALT \> 2 x the upper limit of normal (ULN) * Total bilirubin \> 2 x ULN * Creatinine \> 2.0 mg/dL and * Greater than three prior regimens (where a regimen is defined as a treatment for NHL given after disease progression) * Uncontrolled hypertension * Known history of porphyria, G6PD deficiency, HIV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
| Duration of clinical response | — |
| Safety and tolerability | — |
Countries
United States
Outcome results
None listed