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

Gemin X

Status and phase

Completed

Phase 1

Conditions

Chronic Lymphocytic Leukemia

Treatments

Drug: GX15-070MS

Study type

Interventional

Funder types

Industry

Identifiers

GX004

Details and patient eligibility

About

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

Full description

Both 1 hour and 3 hour infusions of obatoclax every 3 weeks will be evaluated in ascending doses.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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