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A Phase I/II Study of GX15-070MS in Untreated CLL | Clinical Trials | Clareo Health

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COMPLETEDPhase 1NCT00600964

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

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

Lead sponsor: Gemin X•4 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Gemin X

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 12, 2014Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment26

Start dateSep 2004

Last updatedMay 12, 2014

Condition

Chronic Lymphocytic Leukemia

Locations shown

University of CA- San Diego

La Jolla, California

Lombardi Cancer Center

Washington D.C., District of Columbia

Milton S Hershey Medical Center Penn State Cancer Institute

Hershey, Pennsylvania

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 12, 2014Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions