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NCT00076401 Clinical Trial

A Study of Motexafin Gadolinium for the Treatment of Chronic Lymphocytic Leukemia (CLL)

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00076401
Other study ID # PCYC-0216
Secondary ID
Status Terminated
Phase Phase 2
First received January 21, 2004
Last updated June 25, 2014

Study information
Verified date June 2014
Source Pharmacyclics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if the drug motexafin gadolinium will be an effective treatment for patients who have chronic lymphocytic leukemia (CLL) that has come back after treatment or that has stopped responding to treatment.

Recruitment information / eligibility
Status Terminated
Enrollment 27
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Motexafin gadolinium

Locations
Country Name City State
United States Ohio State University Medical Center Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Pharmacyclics

Country where clinical trial is conducted

United States, 

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