Status:
COMPLETED
Study of Obatoclax in Previously Untreated Acute Myeloid Leukemia (AML)
Lead Sponsor:
Gemin X
Conditions:
AML
Eligibility:
All Genders
70+ years
Phase:
PHASE2
Brief Summary
This protocol will evaluate the efficacy of obatoclax in older patients with previously untreated AML.
Detailed Description
The Pilot Safety portion of the study will evaluate the safety of obatoclax administered by a 3 hour infusion for 3 days in a row. The Pilot Schedule portion of the study will randomize 16 patients in...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00684918
Start Date
April 1 2008
End Date
December 1 2009
Last Update
August 26 2013
Active Locations (13)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
The University of Iowa
Iowa City, Iowa, United States, 52242
3
University of Kansas Medical Center Research Institute
Westwood, Kansas, United States, 66205
4
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115