Acute Promyelocytic LeukemiaPhase 1NCT04996030
A Study for Oral SY-2101 for Participants With Acute Promyelocytic Leukemia
A Phase 1 study testing SY-2101 and Arsenic Trioxide in people with Acute Promyelocytic Leukemia, run by Syros Pharmaceuticals at 8 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Promyelocytic Leukemia
- What is being tested?
- SY-2101 and Arsenic Trioxide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 8 sitesUnited States
- Study dates
- 17 Sep 2021to Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Participants must have received ATO plus ATRA induction therapy and must have received or be eligible and planning to receive consolidation therapy with ATO plus ATRA in alignment with National Comprehensive Cancer Network (NCCN) guidelines for low-risk APL prior to their enrollment in the study; or participants must have completed a treatment regimen that included ATO within 6 months prior to the Screening Visit.
- Participants must be able to tolerate full dose ATO per NCCN guidelines.
- Participants must be in morphological complete remission (CR) at the end of induction.
- 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).
Who cannot join
- Participants who have demonstrated relapse and therefore are not eligible for further consolidation.
- Participants currently receiving treatment for a non-APL malignancy (not including basal cell carcinoma, non-melanoma skin cancer, cervical carcinoma in situ, or localized prostate cancer treated with hormone therapy). Participants with history of other cancers should be free of disease for at least 2 years prior to the Screening Visit.
- Participants with an active, life-threatening, or clinically-significant uncontrolled systemic infection requiring hospitalization.
- Immunocompromised participants with increased risk of opportunistic infections, including known human immunodeficiency virus (HIV)-positive participants with cluster of differentiation 4 (CD4) counts ≤350 cells/millimeters (mm^3) or history of opportunistic infection in the last 12 months.
- Participants with a known active or chronic hepatitis B or active hepatitis C virus (HCV) infection. Participants with a history of HCV infection who have completed curative therapy for HCV at least 12 weeks before the Screening Visit and have a documented undetectable viral load at the Screening Visit are eligible for enrollment.
- Participants who have not adequately recovered from a major surgery within 4 weeks of starting study drug administration.
Show all 10Show fewer
- Participants who received any other investigational agents within 4 weeks of the Screening Visit or <5 half-lives since completion of previous investigational therapy have elapsed, whichever is shorter.
- Participants who have a hypersensitivity to arsenic.
- Participants who have experienced the following Grade ≥3 non-hematologic toxicities associated with ATO administration: QT prolongation, hepatotoxicity, neurotoxicity, cardiac function abnormalities. Participants who experienced other severe and life-threatening clinically-significant ATO-related AEs that are considered, in the judgement of the investigator, to increase participant risk with continued ATO treatment are also excluded.
- Other inclusion/exclusion criteria may apply.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Michigan
Ann Arbor, Michigan, 48109
John Hopkins University
Baltimore, Maryland, 21287
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Northwestern Memorial Hospital
Chicago, Illinois, 60208
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Weill Cornell Medical College
New York, New York, 10065
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: An Open-label Phase 1 Study to Evaluate Pharmacokinetics, Safety, and Tolerability of SY-2101 in Adult Patients With Acute Promyelocytic Leukemia
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.
Read the detailed description
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.
- Conditions
- Acute Promyelocytic Leukemia
- Being tested
- SY-2101, Arsenic Trioxide
- Medical subject headings
- Leukemia, Promyelocytic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SY-2101Drug
Also called Oral ATO, Oral Arsenic Trioxide
SY-2101 will be administered per dose and schedule specified in arm description.
Arsenic TrioxideDrug
Also called IV ATO, Trisenox®, IV Arsenic Trioxide
IV ATO will be administered per dose and schedule specified in arm description.
| Study group | Role | What they receive |
|---|---|---|
| Single-Dose PK Module: Sequence 1 | Experimental | 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. Receives: Drug: SY-2101; Drug: Arsenic Trioxide |
| Single-Dose PK Module: Sequence 2 | Experimental | 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. Receives: Drug: SY-2101; Drug: Arsenic Trioxide |
| Single-Dose PK Comparability Module | Experimental | 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. Receives: Drug: SY-2101 |
| Multiple-Dose IV Module | Experimental | 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. Receives: Drug: Arsenic Trioxide |
| Multiple-Dose Oral Module | Experimental | 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. Receives: Drug: SY-2101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single-Dose Module: Maximum Observed Plasma Concentration (Cmax) of SY-2101
Measured: Predose and up to 168 hours postdose
Single-Dose Module: Area Under the Curve (AUC) of SY-2101
Measured: Predose and up to 168 hours postdose
Multiple-Dose Module: Cmax of SY-2101
Measured: 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
Measured: Predose and up to 6 hours postdose on Day 5 and up to 4 hours postdose on Day 26
Secondary outcomes (5)
Single-Dose Module: Cmax of ATO
Measured: Predose and up to 168 hours postdose
Single-Dose Module: AUC of ATO
Measured: Predose and up to 168 hours postdose
Multiple-Dose Module: Cmax of ATO
Measured: 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
Measured: 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
Measured: up to Day 23 for single-dose module and up to Day 56 for multiple-dose module
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start17 Sep 2021
- Primary completion3 Jan 2024
- Study completionApr 2024 (estimated)
Why it stopped: Prioritization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Promyelocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The characterization of single-dose PK will be conducted in an open-label, randomized crossover 3-period, 3-treatment, 2-sequence design, separated by ≥1 week of washout.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syros Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, MD, Study director, Syros Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996030
- Sponsor's protocol ID
- SY-2101-101
- Status last verified
- Jan 2024
- First submitted
- 3 Aug 2021
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ravandi F, Rangaraju S, Kantarjian H, Garcia-Manero G, Yilmaz M, Baker K, Hall T, Grabenstein J, Roy P, Zamboni BA, Zamboni WC, Warlick E, Kelly M, Roth DA, Ghiaur G. A pharmacokinetic and safety study of oral arsenic trioxide in patients with acute promyelocytic leukemia. Blood Adv. 2025 May 13;9(9):2136-2143. doi: 10.1182/bloodadvances.2024015453.
PubMed 40020161
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase 1 Study to Evaluate Pharmacokinetics, Safety, and Tolerability of SY-2101 in Adult Patients With Acute Promyelocytic Leukemia
- ClinicalTrials.gov ID
- NCT04996030
- Acronym / sponsor ID
- SY-2101-101
- Conditions
- Acute Promyelocytic Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Prioritization
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Syros PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 3 Jan 2024 (actual)
- Study completion
- Apr 2024 (estimated)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- The characterization of single-dose PK will be conducted in an open-label, randomized crossover 3-period, 3-treatment, 2-sequence design, separated by ≥1 week of washout.
| Arm | Type | Receives |
|---|---|---|
| Single-Dose PK Module: Sequence 1 | Experimental | Drug: SY-2101, Drug: Arsenic TrioxideParticipants 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. |
| Single-Dose PK Module: Sequence 2 | Experimental | Drug: SY-2101, Drug: Arsenic TrioxideParticipants 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. |
| Single-Dose PK Comparability Module | Experimental | Drug: SY-2101Participants 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. |
| Multiple-Dose IV Module | Experimental | Drug: Arsenic TrioxideParticipants 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. |
| Multiple-Dose Oral Module | Experimental | Drug: SY-2101Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Participants must have received ATO plus ATRA induction therapy and must have received or be eligible and planning to receive consolidation therapy with ATO plus ATRA in alignment with National Comprehensive Cancer Network (NCCN) guidelines for low-risk APL prior to their enrollment in the study; or participants must have completed a treatment regimen that included ATO within 6 months prior to the Screening Visit.
- Participants must be able to tolerate full dose ATO per NCCN guidelines.
- Participants must be in morphological complete remission (CR) at the end of induction.
- 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).
Key exclusion criteria (10 listed)
- Participants who have demonstrated relapse and therefore are not eligible for further consolidation.
- Participants currently receiving treatment for a non-APL malignancy (not including basal cell carcinoma, non-melanoma skin cancer, cervical carcinoma in situ, or localized prostate cancer treated with hormone therapy). Participants with history of other cancers should be free of disease for at least 2 years prior to the Screening Visit.
- Participants with an active, life-threatening, or clinically-significant uncontrolled systemic infection requiring hospitalization.
- Immunocompromised participants with increased risk of opportunistic infections, including known human immunodeficiency virus (HIV)-positive participants with cluster of differentiation 4 (CD4) counts ≤350 cells/millimeters (mm^3) or history of opportunistic infection in the last 12 months.
- Participants with a known active or chronic hepatitis B or active hepatitis C virus (HCV) infection. Participants with a history of HCV infection who have completed curative therapy for HCV at least 12 weeks before the Screening Visit and have a documented undetectable viral load at the Screening Visit are eligible for enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SY-2101Also: Oral ATO, Oral Arsenic TrioxideSY-2101 will be administered per dose and schedule specified in arm description. | Drug | Multiple-Dose Oral Module, Single-Dose PK Comparability Module, Single-Dose PK Module: Sequence 1, Single-Dose PK Module: Sequence 2 |
| Arsenic TrioxideAlso: IV ATO, Trisenox®, IV Arsenic TrioxideIV ATO will be administered per dose and schedule specified in arm description. | Drug | Multiple-Dose IV Module, Single-Dose PK Module: Sequence 1, Single-Dose PK Module: Sequence 2 |
Primary outcome
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
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Derived from this study: PubMed 40020161Ravandi F, Rangaraju S, Kantarjian H, Garcia-Manero G, Yilmaz M, Baker K, Hall T, Grabenstein J, Roy P, Zamboni BA, Zamboni WC, Warlick E, Kelly M, Roth DA, Ghiaur G. A pharmacokinetic and safety study of oral arsenic trioxide in patients with acute promyelocytic leukemia. Blood Adv. 2025 May 13;9(9):2136-2143. doi: 10.1182/bloodadvances.2024015453.
- https://aplstudy.com/Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director, MD study director
Syros Pharmaceuticals Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SY-2101 and Arsenic Trioxide in people with Acute Promyelocytic Leukemia, run by Syros Pharmaceuticals at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single-Dose Module: Maximum Observed Plasma Concentration (Cmax) of SY-2101 (time frame: Predose and up to 168 hours postdose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04996030, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.