Acute Promyelocytic Leukemia (APL)Phase 3LATITUDENCT07296445
A Trial to Investigate Whether Oral Arsenic Trioxide Is Similar to Intravenous Arsenic Trioxide in Pharmacokinetics, Safety, and Efficacy (LATITUDE/SDKARS-301)
A Phase 3 study testing Oral ATO, IV Arsenic Trioxide and all-trans retinoic acid (ATRA) in people with Acute Promyelocytic Leukemia (APL) and Acute Promyelocytic Leukaemia, run by SDK Therapeutics, Inc..
Trial summary
LATITUDE: A Phase 3, Randomized, Open-Label, 3-Cohort, 2-Period, 2- Sequence, Crossover Trial to Evaluate the Pharmacokinetics, Safety, and Efficacy of Oral Arsenic Trioxide Versus Intravenous Arsenic Trioxide for Consolidation Therapy in Participants With Newly Diagnosed, Non-High Risk, Acute Promyelocytic Leukemia… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acute Promyelocytic Leukemia (APL), Acute Promyelocytic Leukaemia, Acute Promyelocytic Leukemia With PML-RARA
- What is being tested?
- Oral ATO, IV Arsenic Trioxide and all-trans retinoic acid (ATRA)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Jan 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants must have diagnosis of newly diagnosed non-high risk APL with a WBC count at diagnosis ≤ 10,000 cells/µL, completed induction with ATO/ATRA and achieved morphologic CR with hematologic recovery
- Eastern Cooperative Oncology Group performance status ≤2
- Adequate liver, kidney, and cardiac function
- Have a life expectancy of at least 9 months
- Negative serum pregnancy test
Who cannot join
- Diagnosis of relapsed or refractory APL.
- Fridericia's corrected QT interval (QTcF) >450 milliseconds (males) and >460 milliseconds (females)
- Any gastrointestinal (GI) issue likely to affect oral drug absorption/metabolism or inability to swallow oral medication
- Prior malignancy or currently receiving treatment for a non-APL malignancy, with the following exceptions: basal cell or squamous cell skin cancer treated with surgical resection, in situ cervical cancer, localized prostate cancer or breast cancer treated with hormone therapy or surgical resection, or other cancer from which the participant has been disease free for at least 2 years.
- Pregnant or nursing females or is of reproductive potential and unwilling to comply with contraceptive requirements.
- Participant has known active or chronic hepatitis B or active hepatitis C (HCV) infection or human immunodeficiency virus (HIV)-positive with detectable viral load.
- Note: Additional inclusion/exclusion criteria may apply, per protocol.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: LATITUDE - A Phase 3, Randomized, Open-Label, 3-Cohort, 2-Period, 2-Sequence, Crossover Trial to Evaluate the Pharmacokinetics, Safety, and Efficacy of Oral Arsenic Trioxide Versus Intravenous Arsenic Trioxide for Consolidation Therapy in Participants With Newly Diagnosed, Non-High-Risk, Acute Promyelocytic Leukemia
LATITUDE: A Phase 3, Randomized, Open-Label, 3-Cohort, 2-Period, 2- Sequence, Crossover Trial to Evaluate the Pharmacokinetics, Safety, and Efficacy of Oral Arsenic Trioxide Versus Intravenous Arsenic Trioxide for Consolidation Therapy in Participants With Newly Diagnosed, Non-High Risk, Acute Promyelocytic Leukemia
Rationale:
Read more
SDK Therapeutics is developing an oral formulation of arsenic trioxide (ATO) for the treatment of acute promyelocytic leukemia (APL). Patients with APL are usually treated with arsenic trioxide (ATO) through an IV along with all-trans retinoic acid (ATRA) taken by mouth. Receiving ATO through an IV requires patients with APL to go to the hospital a lot and get long treatments (sometimes every day over a year of treatment). This can be hard and uncomfortable. If ATO can be taken by mouth, it would be much easier for patients and their families.
Objective:
The main objective is to show that the body absorbs the same amount of ATO whether it's taken by mouth or through an IV. Other objectives include checking if ATO taken by mouth works just as well, causes fewer heart problems, is safe, and improves quality of life compared with ATO given through an IV.
Main trial endpoints:
The main endpoint being measured is how much ATO is in the blood after 5 doses. Another important endpoint is how many patients have no signs of cancer in their blood after 3 rounds of treatment.
Secondary trial endpoints:
Other things being measured include: whether patients stay cancer-free over 2 years; changes in heart rhythm; side effects and lab test results; how patients feel during treatment; how much of ATO is in the blood; and how often patients feel bothered by side effects.
Trial design:
This is an open-label study, meaning everyone knows which treatment they are getting. Patients will get 4 rounds of treatment, each lasting 8 weeks. After that, patients will have check-ups every 3 months to assess safety and disease status for a total of 2 years.
Trial population:
The study includes adults and teens (12 years and older) who have APL, are not high-risk, and have already finished the first part of their treatment (induction) with IV ATO and ATRA.
Interventions:
There are 3 groups in the study:
Cohort A: Takes 0.15 mg/kg Oral ATO for 3 rounds, then switches to 0.15 mg/kg IV ATO for part of the 4th round.
Cohort B: Takes 0.15 mg/kg IV ATO for 3 rounds, then switches to 0.15 mg/kg Oral ATO for part of the 4th round.
Cohort C: Takes 0.15 mg/kg Oral ATO for all 4 rounds.
All cohorts also take 45 mg/m2/day ATRA during certain weeks of each round. Doctors will assess efficacy by checking bone marrow samples before and during treatment to see if the cancer is gone. Special lab tests will be used to look for cancer cells. Safety will be assessed by checking for side effects using blood tests, heart tests, physical exams, and other health checks. Quality of life will be assessed by the patients who will fill out surveys about how they feel during treatment and how much the side effects bother them. The study will also look at how often patients need to go to the doctor or hospital; how treatment affects daily life and work; and how satisfied patients are with their treatment.
- Conditions
- Acute Promyelocytic Leukemia (APL), Acute Promyelocytic Leukaemia, Acute Promyelocytic Leukemia With PML-RARA, Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA, APL, Acute Promyelocytic Leukemia
- Being tested
- Oral ATO, IV Arsenic Trioxide, all-trans retinoic acid (ATRA)
- Keywords
- Oral Arsenic Trioxide, Oral ATO
- Medical subject headings
- Leukemia, Promyelocytic, Acute, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral ATODrug
Oral Arsenic Trioxide
IV Arsenic TrioxideDrug
Intravenous Arsenic Trioxide
all-trans retinoic acid (ATRA)Drug
all-trans retinoic acid (ATRA)
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Cohort A | Experimental | Participants will receive Oral ATO 0.15 mg/kg daily × 5 days a week from Weeks 1 to 4 in the first three 8-week cycles, IV ATO 0.15 mg/kg daily (2-hour infusion) × 5 days in Week 1 of Cycle 4, and oral ATO 0.15 mg/kg daily × 5 days a week from Weeks 2 to 4 of Cycle 4. All adult participants will receive ATRA 45 mg/m2/day in 2 divided doses as background treatment 7 days a week for 2 weeks on and 2 weeks off (Weeks 1, 2, 5 and 6 of each 8-week cycle) beginning in Cycle 1 and ending after Cycle 4 Week 2 Receives: Drug: Oral ATO; Drug: IV Arsenic Trioxide; Drug: all-trans retinoic acid (ATRA) |
| Part 1: Cohort B | Active comparator | Participants will receive IV ATO 0.15 mg/kg daily (2-hour infusion) × 5 days a week from Weeks 1 to 4 in the first three 8-week cycles, oral ATO 0.15 mg/kg daily × 5 days in Week 1 of Cycle 4, and IV ATO 0.15 mg/kg daily (2-hour infusion) × 5 days a week from Weeks 2 to 4 of Cycle 4. All adult participants will receive ATRA 45 mg/m2/day in 2 divided doses as background treatment 7 days a week for 2 weeks on and 2 weeks off (Weeks 1, 2, 5 and 6 of each 8-week cycle) beginning in Cycle 1 and ending after Cycle 4 Week 2 Receives: Drug: Oral ATO; Drug: IV Arsenic Trioxide; Drug: all-trans retinoic acid (ATRA) |
| Part 2: Cohort C | Experimental | Participants will receive Oral ATO 0.15 mg/kg daily × 5 days a week from Weeks 1 to 4 of four 8-week cycles. All adult participants will receive ATRA 45 mg/m2/day in 2 divided doses as background treatment 7 days a week for 2 weeks on and 2 weeks off (Weeks 1, 2, 5 and 6 of each 8-week cycle) beginning in Cycle 1 and ending after Cycle 4 Week 2 Receives: Drug: Oral ATO; Drug: all-trans retinoic acid (ATRA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic exposure (amount of ATO in the blood)
Total 5-dose plasma AsIII AUC
Measured: At the end of Cycle 4, Week 1 (Each cycle is 8 weeks)
Secondary outcomes (8)
Molecular Complete Response (molCR) rate
molCR rate, defined as negative/undetected for PML:RARα by RT-qPCR
Measured: At the end of 3 Cycles of treatment (each cycle is 8 weeks)
Relapse-Free Survival (RFS)
2-year Relapse Free Survival (RFS)
Measured: Assessed for up to 2 years after the first dose of treatment, or until disease progression/relapse or death, whichever occurs first.
Change in Fridericia-corrected QT interval (ΔQTcF interval)
Difference in QTcF between collected values
Measured: At the end of Cycles 3 and 4 (each cycle is 8 weeks)
Adverse events
Frequency, severity, and relatedness of adverse events.
Measured: Up to 9 months
Cardiac AEs related to elevated QTcF
Number of prolonged QTcF interval or other arrhythmias per CTCAE
Measured: Up to 9 months
Pharmacokinetic profile
Peak Plasma Concentration (Cmax)
Measured: At the end of Cycle 4, week 1 (Each cycle is 8 weeks)
Patient Reported Outcomes
Change from baseline as measured by the EORTC QLQ-C30
Measured: Up to 9 months
Patient Reported Outcomes
Proportion of time "bothered by side-effects" as measured by the FACT-GP5
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Promyelocytic Leukemia (APL)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, Open-Label, 3-Cohort, 2-Period, 2- Sequence, Crossover Trial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SDK Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296445
- Sponsor's protocol ID
- SDKARS-301
- Other IDs
- 2025-524329-41-00, 2025
- Acronym
- LATITUDE
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LATITUDE - A Phase 3, Randomized, Open-Label, 3-Cohort, 2-Period, 2-Sequence, Crossover Trial to Evaluate the Pharmacokinetics, Safety, and Efficacy of Oral Arsenic Trioxide Versus Intravenous Arsenic Trioxide for Consolidation Therapy in Participants With Newly Diagnosed, Non-High-Risk, Acute Promyelocytic Leukemia
- ClinicalTrials.gov ID
- NCT07296445
- Acronym / sponsor ID
- LATITUDE / SDKARS-301
- Conditions
- Acute Promyelocytic Leukemia (APL), Acute Promyelocytic Leukaemia, Acute Promyelocytic Leukemia With PML-RARA, Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA, APL, Acute Promyelocytic Leukemia
- Keywords
- Oral Arsenic Trioxide, Oral ATO
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- SDK Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 22 Dec 2025 (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.
LATITUDE: A Phase 3, Randomized, Open-Label, 3-Cohort, 2-Period, 2- Sequence, Crossover Trial to Evaluate the Pharmacokinetics, Safety, and Efficacy of Oral Arsenic Trioxide Versus Intravenous Arsenic Trioxide for Consolidation Therapy in Participants With Newly Diagnosed, Non-High Risk, Acute Promyelocytic Leukemia
Rationale:
SDK Therapeutics is developing an oral formulation of arsenic trioxide (ATO) for the treatment of acute promyelocytic leukemia (APL). Patients with APL are usually treated with arsenic trioxide (ATO) through an IV along with all-trans retinoic acid (ATRA) taken by mouth. Receiving ATO through an IV requires patients with APL to go to the hospital a lot and get long treatments (sometimes every day over a year of treatment). This can be hard and uncomfortable. If ATO can be taken by mouth, it would be much easier for patients and their families.
Objective:
The main objective is to show that the body absorbs the same amount of ATO whether it's taken by mouth or through an IV. Other objectives include checking if ATO taken by mouth works just as well, causes fewer heart problems, is safe, and improves quality of life compared with ATO given through an IV.
Main trial endpoints:
The main endpoint being measured is how much ATO is in the blood after 5 doses. Another important endpoint is how many patients have no signs of cancer in their blood after 3 rounds of treatment.
Secondary trial endpoints:
Other things being measured include: whether patients stay cancer-free over 2 years; changes in heart rhythm; side effects and lab test results; how patients feel during treatment; how much of ATO is in the blood; and how often patients feel bothered by side effects.
Trial design:
This is an open-label study, meaning everyone knows which treatment they are getting. Patients will get 4 rounds of treatment, each lasting 8 weeks. After that, patients will have check-ups every 3 months to assess safety and disease status for a total of 2 years.
Trial population:
The study includes adults and teens (12 years and older) who have APL, are not high-risk, and have already finished the first part of their treatment (induction) with IV ATO and ATRA.
Interventions:
There are 3 groups in the study:
Cohort A: Takes 0.15 mg/kg Oral ATO for 3 rounds, then switches to 0.15 mg/kg IV ATO for part of the 4th round.
Cohort B: Takes 0.15 mg/kg IV ATO for 3 rounds, then switches to 0.15 mg/kg Oral ATO for part of the 4th round.
Cohort C: Takes 0.15 mg/kg Oral ATO for all 4 rounds.
All cohorts also take 45 mg/m2/day ATRA during certain weeks of each round. Doctors will assess efficacy by checking bone marrow samples before and during treatment to see if the cancer is gone. Special lab tests will be used to look for cancer cells. Safety will be assessed by checking for side effects using blood tests, heart tests, physical exams, and other health checks. Quality of life will be assessed by the patients who will fill out surveys about how they feel during treatment and how much the side effects bother them. The study will also look at how often patients need to go to the doctor or hospital; how treatment affects daily life and work; and how satisfied patients are with their treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized, Open-Label, 3-Cohort, 2-Period, 2- Sequence, Crossover Trial
| Arm | Type | Receives |
|---|---|---|
| Part 1: Cohort A | Experimental | Drug: Oral ATO, Drug: IV Arsenic Trioxide, Drug: all-trans retinoic acid (ATRA)Participants will receive Oral ATO 0.15 mg/kg daily × 5 days a week from Weeks 1 to 4 in the first three 8-week cycles, IV ATO 0.15 mg/kg daily (2-hour infusion) × 5 days in Week 1 of Cycle 4, and oral ATO 0.15 mg/kg daily × 5 days a week from Weeks 2 to 4 of Cycle 4. All adult participants will receive ATRA 45 mg/m2/day in 2 divided doses as background treatment 7 days a week for 2 weeks on and 2 weeks off (Weeks 1, 2, 5 and 6 of each 8-week cycle) beginning in Cycle 1 and ending after Cycle 4 Week 2 |
| Part 1: Cohort B | Active comparator | Drug: Oral ATO, Drug: IV Arsenic Trioxide, Drug: all-trans retinoic acid (ATRA)Participants will receive IV ATO 0.15 mg/kg daily (2-hour infusion) × 5 days a week from Weeks 1 to 4 in the first three 8-week cycles, oral ATO 0.15 mg/kg daily × 5 days in Week 1 of Cycle 4, and IV ATO 0.15 mg/kg daily (2-hour infusion) × 5 days a week from Weeks 2 to 4 of Cycle 4. All adult participants will receive ATRA 45 mg/m2/day in 2 divided doses as background treatment 7 days a week for 2 weeks on and 2 weeks off (Weeks 1, 2, 5 and 6 of each 8-week cycle) beginning in Cycle 1 and ending after Cycle 4 Week 2 |
| Part 2: Cohort C | Experimental | Drug: Oral ATO, Drug: all-trans retinoic acid (ATRA)Participants will receive Oral ATO 0.15 mg/kg daily × 5 days a week from Weeks 1 to 4 of four 8-week cycles. All adult participants will receive ATRA 45 mg/m2/day in 2 divided doses as background treatment 7 days a week for 2 weeks on and 2 weeks off (Weeks 1, 2, 5 and 6 of each 8-week cycle) beginning in Cycle 1 and ending after Cycle 4 Week 2 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must have diagnosis of newly diagnosed non-high risk APL with a WBC count at diagnosis ≤ 10,000 cells/µL, completed induction with ATO/ATRA and achieved morphologic CR with hematologic recovery
- Eastern Cooperative Oncology Group performance status ≤2
- Adequate liver, kidney, and cardiac function
- Have a life expectancy of at least 9 months
- Negative serum pregnancy test
Key exclusion criteria (7 listed)
- Diagnosis of relapsed or refractory APL.
- Fridericia's corrected QT interval (QTcF) >450 milliseconds (males) and >460 milliseconds (females)
- Any gastrointestinal (GI) issue likely to affect oral drug absorption/metabolism or inability to swallow oral medication
- Prior malignancy or currently receiving treatment for a non-APL malignancy, with the following exceptions: basal cell or squamous cell skin cancer treated with surgical resection, in situ cervical cancer, localized prostate cancer or breast cancer treated with hormone therapy or surgical resection, or other cancer from which the participant has been disease free for at least 2 years.
- Pregnant or nursing females or is of reproductive potential and unwilling to comply with contraceptive requirements.
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 |
|---|---|---|
| Oral ATOOral Arsenic Trioxide | Drug | Part 1: Cohort A, Part 1: Cohort B, Part 2: Cohort C |
| IV Arsenic TrioxideIntravenous Arsenic Trioxide | Drug | Part 1: Cohort A, Part 1: Cohort B |
| all-trans retinoic acid (ATRA)all-trans retinoic acid (ATRA) | Drug | Part 1: Cohort A, Part 1: Cohort B, Part 2: Cohort C |
Primary outcome
Pharmacokinetic exposure (amount of ATO in the blood)
Time frame: At the end of Cycle 4, Week 1 (Each cycle is 8 weeks)
Total 5-dose plasma AsIII AUC
8 secondary outcomes
Molecular Complete Response (molCR) rate
Time frame: At the end of 3 Cycles of treatment (each cycle is 8 weeks)
Relapse-Free Survival (RFS)
Time frame: Assessed for up to 2 years after the first dose of treatment, or until disease progression/relapse or death, whichever occurs first.
Change in Fridericia-corrected QT interval (ΔQTcF interval)
Time frame: At the end of Cycles 3 and 4 (each cycle is 8 weeks)
Adverse events
Time frame: Up to 9 months
Cardiac AEs related to elevated QTcF
Time frame: Up to 9 months
Pharmacokinetic profile
Time frame: At the end of Cycle 4, week 1 (Each cycle is 8 weeks)
Patient Reported Outcomes
Time frame: Up to 9 months
Patient Reported Outcomes
Time frame: Up to 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral ATO, IV Arsenic Trioxide and all-trans retinoic acid (ATRA) in people with Acute Promyelocytic Leukemia (APL) and Acute Promyelocytic Leukaemia, run by SDK Therapeutics, Inc..
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 7 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: opening soon, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danelle James, MD (+16196063187, Danelle.James@sdktx.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic exposure (amount of ATO in the blood) (time frame: At the end of Cycle 4, Week 1 (Each cycle is 8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2025.