The purpose of this study is to evaluate the long-term efficacy and safety profile of tosedostat in elderly patients suffering from refractory or relapsed Acute Myeloid Leukemia.
Extension protocol to the OPAL Study (CHR-2797-038). Study mimics normal clinical practice; few procedures and visits are therefore mandated by the protocol. Timing of bone marrow assessment is also left at the investigator's discretion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
120mg once daily oral for 48 weeks
UCLA Division of Hematology/Oncology
Los Angeles, California, United States
University of Michigan
Ann Arbor, Michigan, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
New York Presbyterian Hospitacl
New York, New York, United States
Safety and Tolerability of extended treatment with tosedostat
Primary outcome will be assessed using the following procedures/data: * Physical exams * Vital signs * Electrocardiography * Laboratory parameters (hematology, chemistry, urinalysis) * Adverse events * Serious adverse events
Time frame: Protocol mandated visits every 12 weeks
Efficacy of extended treatment with tosedostat
The secondary outcome will be assessed using the following parameters: * Overall survival * Relapse-free survival * Event-free survival * Clinical responses (Complete Remission, Complete Remission with Incomplete Platelet Recovery, Morphological Leukemia-Free State, Partial Remission, Stable Disease, Progressive Disease) including best response and time to response * Duration of clinical responses.
Time frame: Protocol-mandated visits every 12 weeks
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Duke University Medical Center
Durham, North Carolina, United States
MD Anderson
Houston, Texas, United States