Acute Myeloid Leukemia Clinical Trial

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

Summary

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

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Full 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 to one of two cohorts: 1) patients receiving obatoclax administered by a 3 hour infusion for 3 days in a row or 2) patients receiving obatoclax administered by a 24 hour infusion for 3 days in a row. The schedule with the best overall efficacy and safety in the Pilot Schedule portion of the study will then be utilized in the Phase II portion of the study.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

18

Study ID:

NCT00684918

Recruitment Status:

Completed

Sponsor:

Gemin X

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There are 13 Locations for this study

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Northwestern University
Chicago Illinois, 60611, United States
The University of Iowa
Iowa City Iowa, 52242, United States
University of Kansas Medical Center Research Institute
Westwood Kansas, 66205, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
St. Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States
University of Michigan Health System
Ann Arbor Michigan, 48109, United States
Michigan State University - Breslin Cancer Center
Lansing Michigan, 48910, United States
St. Vincent's Comprehensive Cancer Center
New York New York, 10011, United States
Legacy Emanuel Hospital & Health Center
Portland Oregon, 97210, United States
Penn State Hershey Cancer Institute-Clinical Trials Office
Hershey Pennsylvania, 17033, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Benaroya Research Institute at Virginia Mason
Seattle Washington, 98101, United States
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

18

Study ID:

NCT00684918

Recruitment Status:

Completed

Sponsor:


Gemin X

How clear is this clinincal trial information?

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