Chronic Lymphocytic Leukemia Clinical Trial

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

Summary

This protocol is being run to determine the best phase II dose and schedule of obatoclax in patients with previously untreated leukemia-cll/" >CLL.

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Full Description

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

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Eligibility 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

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

26

Study ID:

NCT00600964

Recruitment Status:

Completed

Sponsor:

Gemin X

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There are 5 Locations for this study

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University of CA- San Diego
La Jolla California, 92093, United States
Lombardi Cancer Center
Washington District of Columbia, 20007, United States
Milton S Hershey Medical Center Penn State Cancer Institute
Hershey Pennsylvania, 17033, United States
UT MD Anderson Cancer Center
Houston Texas, 77030, United States
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

26

Study ID:

NCT00600964

Recruitment Status:

Completed

Sponsor:


Gemin X

How clear is this clinincal trial information?

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