This is a Phase II trial conducted at multiple centers for evaluation of the pharmacodynamic activity and the overall response rate contributed by the combination agents of GTI-2040 and High Dose Cytarabine (HiDAC) in Refractory and Relapsed Acute Myeloid Leukemia (AML).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
GTI-2040 will be administered one day after HiDAC in the pilot PD study and one day before HiDAC in the Phase II study for a cycle. Those who achieve a complete remission (CR) will be permitted to receive one cycle of consolidation of GTI-2040 and HiDAC
San Francisco Veterans Affairs Medical Center
San Francisco, California, United States
UCSF Medical Center
San Francisco, California, United States
Northside Hospital
Atlanta, Georgia, United States
Indiana Cancer Research Institute
Indianapolis, Indiana, United States
Overall Response Rate of GTI-2040 Combined With HiDAC in Refractory or Relapsed AML
Overall Response was defined as whether or not the patient achieved complete remission (CR) and CR with incomplete blood count recovery (CRi) while on the study.
Time frame: at 29-35 days
Summary of Treatment Emergent Adverse Events
An adverse event (AE) was defined as any unintended or undesirable experience that occurred during the course of the clinical investigation, regardless of whether or not it was considered to be study drug-related. This included any newly occurring event or a previous condition that had increased in severity or frequency since the administration of study drug.
Time frame: 30 days after the last dose
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Roswell Park Cancer Institute
Buffalo, New York, United States
The Mount Sinai Hospital
New York, New York, United States
The Ohio State University
Columbus, Ohio, United States