Status:
COMPLETED
Study of Motexafin Gadolinium for the Treatment of Non-Hodgkin's Lymphoma
Lead Sponsor:
Pharmacyclics LLC.
Conditions:
Lymphoma
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 motexafi...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00086034
Last Update
May 15 2007
Active Locations (7)
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1
San Diego, California, United States, 92121
2
Stanford, California, United States, 94305
3
Miami, Florida, United States, 33136
4
Chicago, Illinois, United States, 60611