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

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gemin X
• Treatments: Obatoclax

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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