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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing SY-2101, an oral form of a drug used to treat leukemia, in patients with acute promyelocytic leukemia (APL) who are in remission. The goal is to see if taking the drug by mouth is as effective as the current IV method in preventing the cancer from coming back. Bisantrene, a new drug, has shown effectiveness in treating leukemia with manageable side effects.

Eligible Conditions
  • Acute Promyelocytic Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.
80 Previous Clinical Trials
16,500 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 Oral Module, Multiple-Dose IV 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
~4 spots leftby Dec 2025
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