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

Gemin X26 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Lymphocytic Leukemia

Interventions

GX15-070MSDRUG

A 60-minute or 3-hour IV infusion every 2-3 weeks.

GX15-070MSDRUG

GX15-070MS at various doses and schedules

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

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

Outcomes

Primary Outcomes

Determine the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks

Time frame: 14 days

Secondary Outcomes

Estimate the response rate of previously-treated patients with CLL at the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks.

Time frame: 14 days

Data from ClinicalTrials.gov

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