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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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2009 Phase 2 trial • 22 Patients • NCT0002425818%
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.
80 Previous Clinical Trials
16,584 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Multiple-Dose Oral Module
- Group 2: Multiple-Dose IV Module
- Group 3: Single-Dose PK Module: Sequence 1
- Group 4: Single-Dose PK Module: Sequence 2
- Group 5: Single-Dose PK Comparability Module
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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