A Phase I/II Study of GX15-070MS in Untreated CLL

Completed · Phase 1

Conditions studied: Chronic Lymphocytic Leukemia

In brief

This protocol is being run to determine the best phase II dose and schedule of obatoclax in patients with previously untreated CLL.

Key facts

Study ID

NCT00600964

Run by

Gemin X

People needed

26

Starts

2004-09-01

Expected to finish

2006-01-01

Last updated by the study team

2014-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed B-CLL
• Previous standard systemic chemotherapy, including fludarabine. There are no limitations on additional, allowable type and amount of prior therapy. Acute toxicities from prior therapy must have resolved to ≤Grade 1
• Age ≥18 years
• ECOG Performance Status ≤1
• Life expectancy of >8 weeks

You may not qualify if…

• Patients receiving any other investigational agents (e.g., under another IND) or commercial agents or therapies administered with the intent to treat their malignancy
• Patients with history of seizure disorders
• Pregnant women and women who are breast feeding
• HIV-positive patients receiving combination anti-retroviral therapy

Where it is running

• University of CA- San Diego — La Jolla, California, United States
• Lombardi Cancer Center — Washington D.C., District of Columbia, United States
• Milton S Hershey Medical Center Penn State Cancer Institute — Hershey, Pennsylvania, United States
• UT MD Anderson Cancer Center — Houston, Texas, United States
• Princess Margaret Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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