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Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Leukemia, Lymphocytic, Chronic

Thank you

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 CenterColumbus, Ohio  43210