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

Phase 2

Completed

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 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.

Recruitment & Eligibility

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:
1. Total bilirubin < or = 2 mg/dL unless resulting from hemolysis,
2. Aspartate transaminase (AST [SGOT])/alanine transaminase (ALT [SGPT]) < or = 2.5 x institutional ULN
3. 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

Arm && Interventions

Group	Intervention	Description
Experimental	Obatoclax	In the Pilot Schedule portion of the study 3 hour vs 24 hour infusion schedules of obatoclax.

Primary Outcome Measures

Name	Time	Method
Determine the rate of morphologic CR after treatment in the obatoclax single-agent therapy in older patients with previously untreated AML.	4 weeks

Secondary Outcome Measures

Name	Time	Method

Locations (13): Princess Margaret Hospital
🇨🇦
Toronto, Ontario, Canada
Northwestern University
🇺🇸
Chicago, Illinois, United States
The University of Iowa
🇺🇸
Iowa City, Iowa, United States
St. Vincent's Comprehensive Cancer Center
🇺🇸
New York, New York, United States
MD Anderson Cancer Center
🇺🇸
Houston, Texas, United States
Benaroya Research Institute at Virginia Mason
🇺🇸
Seattle, Washington, United States
Penn State Hershey Cancer Institute-Clinical Trials Office
🇺🇸
Hershey, Pennsylvania, United States
University of Kansas Medical Center Research Institute
🇺🇸
Westwood, Kansas, United States
Michigan State University - Breslin Cancer Center
🇺🇸
Lansing, Michigan, 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
Legacy Emanuel Hospital & Health Center
🇺🇸
Portland, Oregon, United States