Study of Obatoclax in Previously Untreated Acute Myeloid Leukemia (AML)
A Multicenter, Open-Label, 2-Stage, Phase II Study of Single-Agent Obatoclax Mesylate Administered For Three Consecutive Days Every 2 Weeks to Older Patients With Previously Untreated Acute Myeloid Leukemia (AML)
1 other identifier
interventional
18
2 countries
13
Brief Summary
This protocol will evaluate the efficacy of obatoclax in older patients with previously untreated AML.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2008
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 23, 2008
CompletedFirst Posted
Study publicly available on registry
May 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedAugust 26, 2013
August 1, 2013
1.3 years
May 23, 2008
August 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the rate of morphologic CR after treatment in the obatoclax single-agent therapy in older patients with previously untreated AML.
4 weeks
Study Arms (1)
Experimental
EXPERIMENTALIn the Pilot Schedule portion of the study 3 hour vs 24 hour infusion schedules of obatoclax.
Interventions
A 3-hour IV infusion for 3 consecutive days or a 24-hour infusion for 3 consecutive days every 2 weeks for up to 6 cycles.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gemin Xlead
Study Sites (13)
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 2M9, Canada
Related Publications (1)
Schimmer AD, Raza A, Carter TH, Claxton D, Erba H, DeAngelo DJ, Tallman MS, Goard C, Borthakur G. A multicenter phase I/II study of obatoclax mesylate administered as a 3- or 24-hour infusion in older patients with previously untreated acute myeloid leukemia. PLoS One. 2014 Oct 6;9(10):e108694. doi: 10.1371/journal.pone.0108694. eCollection 2014.
PMID: 25285531DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jean Viallet, MD
Gemin X Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2008
First Posted
May 28, 2008
Study Start
April 1, 2008
Primary Completion
August 1, 2009
Study Completion
December 1, 2009
Last Updated
August 26, 2013
Record last verified: 2013-08