SY-2101 is being studied as a treatment for participants with a type of leukemia called acute promyelocytic leukemia (APL). SY-2101 is an oral formulation of a drug called arsenic trioxide (ATO). ATO is already used to treat APL in a formulation that is given as an intravenous (IV) infusion (through a needle in the arm). SY-2101 is a formulation of ATO that is taken orally (by mouth). This trial will include participants with APL in remission, who are receiving standard of care (SOC) treatment with all-trans-retinoic acid (ATRA) and IV ATO, during the consolidation phase of chemotherapy or within the past 6 months. The participants in this trial will receive continued treatment with ATO and ATRA to help keep their cancer from coming back. There will be some weeks when participants receive IV ATO and others when they receive SY-2101 (ATO taken orally). Participants with high-risk APL may be eligible for part 1 or 4 of the study for the 6 months following completion of their standard of care ATRA and ATO treatment.
This study includes 4 parts. In the first part, enrolled participants will receive a single dose of IV ATO, followed a week later by a single dose of SY-2101, SY-2101 will be administered to participants in either a fed or a fasted condition. A week after that, participants will receive a second, a single dose of SY-2101, with some participants taking this dose in a fed state and other participants taking this dose in a fasted condition. After each of these doses, blood draws and safety assessments will be performed. In the second part, enrolled participants will receive IV ATO according to the standard of care, with collection of blood and safety assessments. In the third part, enrolled participants who are documented to be in molecular remission will receive SY-2101 in place of IV ATO during the 4th cycle of consolidation, with the collection of blood and safety assessments throughout the cycle. In the fourth part, enrolled participants will receive two single-dose treatments of SY-2101 approximately one week apart.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
SY-2101 will be administered per dose and schedule specified in arm description.
IV ATO will be administered per dose and schedule specified in arm description.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
John Hopkins University
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Weill Cornell Medical College
New York, New York, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Single-Dose Module: Maximum Observed Plasma Concentration (Cmax) of SY-2101
Time frame: Predose and up to 168 hours postdose
Single-Dose Module: Area Under the Curve (AUC) of SY-2101
Time frame: Predose and up to 168 hours postdose
Multiple-Dose Module: Cmax of SY-2101
Time frame: Predose and up to 6 hours postdose on Day 5 and up to 4 hours postdose on Day 26
Multiple-Dose Module: AUC of SY-2101
Time frame: Predose and up to 6 hours postdose on Day 5 and up to 4 hours postdose on Day 26
Single-Dose Module: Cmax of ATO
Time frame: Predose and up to 168 hours postdose
Single-Dose Module: AUC of ATO
Time frame: Predose and up to 168 hours postdose
Multiple-Dose Module: Cmax of ATO
Time frame: Predose and up to 6 hours postdose on Day 5 and up to 4 hours postdose on Day 26
Multiple-Dose Module: AUC of ATO
Time frame: Predose and up to 6 hours postdose on Day 5 and up to 4 hours postdose on Day 26
Number of Participants With Adverse Events
Time frame: up to Day 23 for single-dose module and up to Day 56 for multiple-dose module
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