Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Leukemia, Leukemia, Lymphocytic, Chronic
Both
Leukemia, Leukemia, Lymphocytic, Chronic
Trial Information
Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Inclusion Criteria:
- At least 18 years old
- Refractory or relapsed CLL
- ECOG performance status score of 0, 1, or 2
- Each patient must sign a study-specific informed consent form
Exclusion Criteria:
Laboratory values of:
- Platelet count <30,000/uL
- AST or ALT >2 x the upper limit of normal (ULN)
- Total bilirubin >2 x ULN
- Creatinine >2.0 mg/dL
- Chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids, or systemic
biologic anticancer therapy within 21 days before beginning study treatment
- Women who are pregnant or lactating
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
PCYC-0216
NCT ID:
NCT00076401
Start Date:
Completion Date:
Related Keywords:
- Leukemia
- Leukemia, Lymphocytic, Chronic
- CLL
- chronic lymphocytic leukemia
- relapsed chronic lymphocytic leukemia
- refractory chronic lymphocytic leukemia
- Leukemia
- Motexafin gadolinium
- Chronic leukemia
- Lymphocytic leukemia, chronic
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
Name | Location |
|---|---|
| Ohio State University Medical Center | Columbus, Ohio 43210 |
