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Arsenic Trioxide

SY-2101 for Acute Promyelocytic Leukemia

Phase 1
Waitlist Available
Research Sponsored by Syros Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have a serum or high-sensitivity urine pregnancy test (for females of childbearing potential) that is negative at the Screening Visit and immediately prior to initiation of study treatment (first dose of study drug).
Participants must have a diagnosis of APL characterized by the presence of the t(15;17) translocation or PML/RARA gene expression via reverse transcription polymerase chain reaction (RT-PCR), fluorescence in situ hybridization (FISH), or cytogenetics. Participants with low-risk APL may be eligible for all parts of this study; participants with high-risk APL are only eligible for the single-dose modules if they have completed a treatment regimen that included ATO within 6 months prior to the Screening Visit.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose and up to 6 hours postdose on day 5 and up to 4 hours postdose on day 26
Awards & highlights

Study Summary

This trial is studying SY-2101, an oral formulation of a drug called arsenic trioxide, as a treatment for participants with a type of leukemia called acute promyelocytic leukemia (APL).

Eligible Conditions
  • Acute Promyelocytic Leukemia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose and up to 6 hours postdose on day 5 and up to 4 hours postdose on day 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose and up to 6 hours postdose on day 5 and up to 4 hours postdose on day 26 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Multiple-Dose Module: AUC of SY-2101
Multiple-Dose Module: Cmax of SY-2101
Single-Dose Module: Area Under the Curve (AUC) of SY-2101
+1 more
Secondary outcome measures
Multiple-Dose Module: AUC of ATO
Multiple-Dose Module: Cmax of ATO
Number of Participants With Adverse Events
+2 more

Side effects data

From 2009 Phase 2 trial • 22 Patients • NCT00024258
18%
Bone pain
18%
Infection NOS
18%
Infection w/o neutropenia
14%
Constipation
14%
Edema
14%
Nausea
14%
Pain, other
14%
Vomiting
14%
Neutrophil count decrease
14%
Cough
14%
Anemia
9%
Anorexia
9%
Gastrointestinal other
9%
Anxiety
9%
Platelet count decreased
9%
Respiratory, thoracic and mediastinal disorders - Other, specify Respiratory disorder
9%
Tumor pain
9%
Dyspnea
9%
Fever
9%
Neutrophil count decreased
5%
Febrile Neutropenia
5%
Catheter related infection
5%
Hypertension
5%
Renal failure
5%
Blood bilirubin increased
5%
Bruising
5%
Conjunctivitis
5%
Neurology, other
5%
Hyperkalemia
5%
Hypocalcemia
5%
Electrocardiogram QT corrected interval prolonged
5%
Hyperglycemia
5%
White blood cell decreased
5%
Purpura
5%
Pleural effusion
5%
Alanine aminotransferase increased
5%
Sinus tachycardia
5%
Urinary retention
5%
Weight loss
5%
Dry Eye
5%
Dehydration
5%
Hypercalcemia
5%
Neuralgia
5%
Fatigue
5%
Mucositis
5%
Aspartate aminotransferase increased
5%
Hypermagnesemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arsenic Trioxide

Trial Design

5Treatment groups
Experimental Treatment
Group I: Single-Dose PK Module: Sequence 2Experimental Treatment2 Interventions
Participants will receive IV ATO in a fasted state on Day 1, SY-2101 in a fasted state on Day 8, and SY-2101 in a fed state on Day 15 during Weeks 6, 7, and 8 of any consolidation cycle being received as part of SOC treatment consolidation cycle.
Group II: Single-Dose PK Module: Sequence 1Experimental Treatment2 Interventions
Participants will receive IV ATO in a fasted state on Day 1, SY-2101 in a fed state on Day 8, and SY-210 in a fasted state on Day 15 during Weeks 6, 7, and 8 of any consolidation cycle being received as part of SOC treatment consolidation cycle.
Group III: Single-Dose PK Comparability ModuleExperimental Treatment1 Intervention
Participants will receive two single-dose treatments of SY-2101, with separated from one another by approximately 1 week and separated from any preceding IV ATO dose by at least 72 hours.
Group IV: Multiple-Dose Oral ModuleExperimental Treatment1 Intervention
Participants will receive SY-2101, QD, 5 days/week for 28 days as a part of one cycle (Cycle 4; Weeks 1 through 4) of SOC treatment consolidation.
Group V: Multiple-Dose IV ModuleExperimental Treatment1 Intervention
Participants will receive IV ATO, once daily (QD), 5 days/week for 28 days as a part of at least one cycle (Weeks 1 through 4) of SOC treatment consolidation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Arsenic Trioxide
2011
Completed Phase 3
~240

Find a Location

Who is running the clinical trial?

Syros PharmaceuticalsLead Sponsor
5 Previous Clinical Trials
1,012 Total Patients Enrolled
Medical Director, MDStudy DirectorSyros Pharmaceuticals Inc.
76 Previous Clinical Trials
16,228 Total Patients Enrolled

Media Library

Arsenic Trioxide (Arsenic Trioxide) Clinical Trial Eligibility Overview. Trial Name: NCT04996030 — Phase 1
Acute Promyelocytic Leukemia Research Study Groups: Multiple-Dose IV Module, Multiple-Dose Oral Module, Single-Dose PK Module: Sequence 1, Single-Dose PK Module: Sequence 2, Single-Dose PK Comparability Module
Acute Promyelocytic Leukemia Clinical Trial 2023: Arsenic Trioxide Highlights & Side Effects. Trial Name: NCT04996030 — Phase 1
Arsenic Trioxide (Arsenic Trioxide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04996030 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies available for those who wish to participate in this research?

"Indeed. According to the details hosted on clinicaltrials.gov, recruitment for this trial is still underway - it was initially posted on September 17th 2021 and last edited July 12th 2022. In total 24 participants are needed across 5 different medical facilities."

Answered by AI

Are there any precedent investigations involving SY-2101?

"Currently, 14 trials of SY-2101 are taking place with 3 reaching the last stage. Most notably, Guangzhou in Guangdong is one of 234 locations studying this drug's efficacy and safety."

Answered by AI

How many participants are actively involved in this trial?

"This study requires 24 suitable participants. For those interested, they can join the trial at Clinical Trial Site 4 in Ann Arbor, Michigan or Clinical Trial Site 2 in Birmingham, Alabama."

Answered by AI

Do any of the research facilities in the US have this trial underway?

"Enrolment to this clinical trial is possible at 5 locations, such as Clinical Trial Site 4 in Ann Arbor and Clinical Trial Site 2 in Birmingham. Also available are facilities like Clinical Trial site 1 in Houston among other centres."

Answered by AI

Has the Federal Drug Administration sanctioned SY-2101?

"Due to the lack of real-world evidence, SY-2101's safety rating is a 1. This Phase 1 trial only provides preliminary data regarding efficacy and safety profiles."

Answered by AI
~5 spots leftby Mar 2025