Study of Obatoclax in Previously Untreated Acute Myeloid Leukemia (AML)

Completed · Phase 2

Conditions studied: AML

In brief

This protocol will evaluate the efficacy of obatoclax in older patients with previously untreated AML.

Key facts

Study ID

NCT00684918

Run by

Gemin X

People needed

18

Starts

2008-04-01

Expected to finish

2009-12-01

Last updated by the study team

2013-08-26

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed AML
• No prior chemotherapy for AML (with the exception that the patients enrolled in the Pilot Safety evaluation may have had 1 prior therapy)
• Age ≥70 years
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2
• Patients must have normal organ function as defined below:
• Total bilirubin < or = 2 mg/dL unless resulting from hemolysis,
• Aspartate transaminase (AST [SGOT])/alanine transaminase (ALT [SGPT]) < or = 2.5 x institutional ULN
• Creatinine within normal institutional limits, OR creatinine clearance > or = 50 mL/min/1.73 meters squared for patients with creatinine levels above institutional ULN

You may not qualify if…

• Patients who have received or are receiving any other investigational or commercial agents or therapies administered with the intent to treat their malignancy (with the exception that the patients enrolled in the pilot safety evaluation may have had 1 prior therapy)
• patients with history of allergic reactions attributed to components of the formulated product (PEG300 and polysorbate 20)
• patients with history of seizure disorders or central nervous system leukemia
• patients with uncontrolled, intercurrent illness including, but not limited to, symptomatic neurological illness; active, uncontrolled, systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; significant pulmonary disease or hypoxia; or psychiatric illness/social situations that would limit compliance with study requirements
• Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy

Where it is running

• Northwestern University — Chicago, Illinois, United States
• The University of Iowa — Iowa City, Iowa, United States
• University of Kansas Medical Center Research Institute — Westwood, Kansas, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• St. Joseph Mercy Hospital — Ann Arbor, Michigan, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Michigan State University - Breslin Cancer Center — Lansing, Michigan, United States
• St. Vincent's Comprehensive Cancer Center — New York, New York, United States
• Legacy Emanuel Hospital & Health Center — Portland, Oregon, United States
• Penn State Hershey Cancer Institute-Clinical Trials Office — Hershey, Pennsylvania, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Benaroya Research Institute at Virginia Mason — Seattle, Washington, United States
• Princess Margaret Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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